Trial Outcomes & Findings for Effect of Probiotic Supplementation on the Immune System in Patients With Ulcerative Colitis in Amman, Jordan (NCT NCT04223479)
NCT ID: NCT04223479
Last Updated: 2024-09-19
Results Overview
The level of Immunoglobulin (Ig) A in mg/dL was tested at the end of follow-up (after 6 weeks of follow-up) based on an Immunoturbidimetric assay using Cobas-C501
Recruitment status
COMPLETED
Study phase
PHASE2/PHASE3
Target enrollment
30 participants
Primary outcome timeframe
at the end of 6 weeks of follow-up
Results posted on
2024-09-19
Participant Flow
Assessed for eligibility (n=300) Excluded (n= 270) * Not meeting inclusion criteria (n=229) * Declined to participate (n=15) * Other reasons (n=26) Randomized (n=30)
Participant milestones
| Measure |
Placebo Group
In this intervention arm Placebo arm received three oral viable capsules daily, containing polysaccharides, without any viable probiotics matching the probiotic capsules in appearance, smell, and taste.
Placebos: The Placebos will be coded in a specific label by a researcher who will not be in contact with the participants and administrated randomly based on gender in a double-blind manner. The patient will receive 2 bottles of the placebo every 2 weeks and will be followed weekly for 6 weeks.
|
Probiotic Group
In this intervention arm, the patients will receive oral viable capsules of probiotic contain (1\*10 10 colony-forming unit (CFU)/g) of lactobacillus (Lactobacillus rhamnosus , Lactobacillus acidophilus, Lactobacillus reuteri, Lactobacillus paracasei, Lactobacillus casei, Lactobacillus gasseri, Lactobacillus plantarum) and bifidobacteria (Bifidobacterium lactis, Bifidobacterium breve, Bifidobacterium bifidum, Bifidobacterium longum, Bifidobacterium infantis) species three times a per day
Probiotic Formula Capsule: The Probiotic will be coded in a specific label by a researcher who will not be in contact with the participants and administrated randomly based on gender in a double-blind manner. The patient will receive 2 bottles of the drug every 2 weeks and will be followed weekly for 6 weeks.
|
|---|---|---|
|
Overall Study
STARTED
|
16
|
14
|
|
Overall Study
COMPLETED
|
12
|
12
|
|
Overall Study
NOT COMPLETED
|
4
|
2
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Effect of Probiotic Supplementation on the Immune System in Patients With Ulcerative Colitis in Amman, Jordan
Baseline characteristics by cohort
| Measure |
Probiotic Formula Capsule
n=16 Participants
In this intervention arm, the patients will receive oral viable capsules of probiotic contain (1\*10 10 colony-forming unit (CFU)/g) of lactobacillus (Lactobacillus rhamnosus , Lactobacillus acidophilus, Lactobacillus reuteri, Lactobacillus paracasei, Lactobacillus casei, Lactobacillus gasseri, Lactobacillus plantarum) and bifidobacteria (Bifidobacterium lactis, Bifidobacterium breve, Bifidobacterium bifidum, Bifidobacterium longum, Bifidobacterium infantis) species three times a per day
Probiotic Formula Capsule: The Probiotic will be coded in a specific label by a researcher who will not be in contact with the participants and administrated randomly based on gender in a double-blind manner. The patient will receive 2 bottles of the drug every 2 weeks and will be followed weekly for 6 weeks.
|
Placebos
n=14 Participants
In this intervention arm Placebo arm received three oral viable capsules daily, containing polysaccharides, without any viable probiotics matching the probiotic capsules in appearance, smell, and taste.
Placebos: The Placebos will be coded in a specific label by a researcher who will not be in contact with the participants and administrated randomly based on gender in a double-blind manner. The patient will receive 2 bottles of the placebo every 2 weeks and will be followed weekly for 6 weeks.
|
Total
n=30 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
16 Participants
n=5 Participants
|
14 Participants
n=7 Participants
|
30 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Sex: Female, Male
Female
|
10 Participants
n=5 Participants
|
8 Participants
n=7 Participants
|
18 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
6 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
12 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
16 Participants
n=5 Participants
|
14 Participants
n=7 Participants
|
30 Participants
n=5 Participants
|
|
Region of Enrollment
Jordan
|
16 participants
n=5 Participants
|
14 participants
n=7 Participants
|
30 participants
n=5 Participants
|
|
Ethnicity
Arabs
|
16 Participants
n=5 Participants
|
14 Participants
n=7 Participants
|
30 Participants
n=5 Participants
|
|
Ethnicity
Others
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Body mass index
|
25.3 kg/m^2
STANDARD_DEVIATION 6.8 • n=5 Participants
|
24.6 kg/m^2
STANDARD_DEVIATION 5.7 • n=7 Participants
|
24.95 kg/m^2
STANDARD_DEVIATION 6.25 • n=5 Participants
|
|
Family history of IBD
Yes
|
5 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
7 Participants
n=5 Participants
|
|
Family history of IBD
No
|
11 Participants
n=5 Participants
|
12 Participants
n=7 Participants
|
23 Participants
n=5 Participants
|
|
History of Probiotic use
Yes
|
1 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
|
History of Probiotic use
No
|
15 Participants
n=5 Participants
|
12 Participants
n=7 Participants
|
27 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: at the end of 6 weeks of follow-upThe level of Immunoglobulin (Ig) A in mg/dL was tested at the end of follow-up (after 6 weeks of follow-up) based on an Immunoturbidimetric assay using Cobas-C501
Outcome measures
| Measure |
Placebo Group
n=12 Participants
In this intervention arm Placebo arm received three oral viable capsules daily, containing polysaccharides, without any viable probiotics matching the probiotic capsules in appearance, smell, and taste.
Placebos: The Placebos will be coded in a specific label by a researcher who will not be in contact with the participants and administrated randomly based on gender in a double-blind manner. The patient will receive 2 bottles of the placebo every 2 weeks and will be followed weekly for 6 weeks.
|
Probiotic Group
n=12 Participants
In this intervention arm, the patients will receive oral viable capsules of probiotic contain (1\*10 10 colony-forming unit (CFU)/g) of lactobacillus (Lactobacillus rhamnosus , Lactobacillus acidophilus, Lactobacillus reuteri, Lactobacillus paracasei, Lactobacillus casei, Lactobacillus gasseri, Lactobacillus plantarum) and bifidobacteria (Bifidobacterium lactis, Bifidobacterium breve, Bifidobacterium bifidum, Bifidobacterium longum, Bifidobacterium infantis) species three times a per day
Probiotic Formula Capsule: The Probiotic will be coded in a specific label by a researcher who will not be in contact with the participants and administrated randomly based on gender in a double-blind manner. The patient will receive 2 bottles of the drug every 2 weeks and will be followed weekly for 6 weeks.
|
|---|---|---|
|
The Level of Immunoglobulin (Ig) A
|
270.42 mg/dL
Standard Deviation 71.79
|
208.63 mg/dL
Standard Deviation 85.84
|
PRIMARY outcome
Timeframe: at the end of 6 weeks of follow upThe level of Immunoglobulin (Ig) G in mg/dL was tested at the end of follow-up (after 6 weeks of follow-up) based on an Immunoturbidimetric assay using Cobas-C501
Outcome measures
| Measure |
Placebo Group
n=12 Participants
In this intervention arm Placebo arm received three oral viable capsules daily, containing polysaccharides, without any viable probiotics matching the probiotic capsules in appearance, smell, and taste.
Placebos: The Placebos will be coded in a specific label by a researcher who will not be in contact with the participants and administrated randomly based on gender in a double-blind manner. The patient will receive 2 bottles of the placebo every 2 weeks and will be followed weekly for 6 weeks.
|
Probiotic Group
n=12 Participants
In this intervention arm, the patients will receive oral viable capsules of probiotic contain (1\*10 10 colony-forming unit (CFU)/g) of lactobacillus (Lactobacillus rhamnosus , Lactobacillus acidophilus, Lactobacillus reuteri, Lactobacillus paracasei, Lactobacillus casei, Lactobacillus gasseri, Lactobacillus plantarum) and bifidobacteria (Bifidobacterium lactis, Bifidobacterium breve, Bifidobacterium bifidum, Bifidobacterium longum, Bifidobacterium infantis) species three times a per day
Probiotic Formula Capsule: The Probiotic will be coded in a specific label by a researcher who will not be in contact with the participants and administrated randomly based on gender in a double-blind manner. The patient will receive 2 bottles of the drug every 2 weeks and will be followed weekly for 6 weeks.
|
|---|---|---|
|
The Level of Immunoglobulin (Ig) G
|
1267.36 mg/dL
Standard Deviation 177.6
|
1214.70 mg/dL
Standard Deviation 236.3
|
PRIMARY outcome
Timeframe: at the end of 6 weeks of follow-upThe level of Immunoglobulin (Ig) M in mg/dL was tested at the end of follow-up (after 6 weeks of follow-up) based on an Immunoturbidimetric assay using Cobas-C501
Outcome measures
| Measure |
Placebo Group
n=12 Participants
In this intervention arm Placebo arm received three oral viable capsules daily, containing polysaccharides, without any viable probiotics matching the probiotic capsules in appearance, smell, and taste.
Placebos: The Placebos will be coded in a specific label by a researcher who will not be in contact with the participants and administrated randomly based on gender in a double-blind manner. The patient will receive 2 bottles of the placebo every 2 weeks and will be followed weekly for 6 weeks.
|
Probiotic Group
n=12 Participants
In this intervention arm, the patients will receive oral viable capsules of probiotic contain (1\*10 10 colony-forming unit (CFU)/g) of lactobacillus (Lactobacillus rhamnosus , Lactobacillus acidophilus, Lactobacillus reuteri, Lactobacillus paracasei, Lactobacillus casei, Lactobacillus gasseri, Lactobacillus plantarum) and bifidobacteria (Bifidobacterium lactis, Bifidobacterium breve, Bifidobacterium bifidum, Bifidobacterium longum, Bifidobacterium infantis) species three times a per day
Probiotic Formula Capsule: The Probiotic will be coded in a specific label by a researcher who will not be in contact with the participants and administrated randomly based on gender in a double-blind manner. The patient will receive 2 bottles of the drug every 2 weeks and will be followed weekly for 6 weeks.
|
|---|---|---|
|
The Level of Immunoglobulin (Ig) M
|
114.64 mg/dL
Standard Deviation 62.03
|
104.10 mg/dL
Standard Deviation 39.57
|
PRIMARY outcome
Timeframe: at the end of 6 weeks of follow-upThe Level of Interleukin (IL)-6 in pg/ml measured aat the end of follow-up (after 6 weeks of follow-up) by a two-site sandwich Enzyme-Linked Immunosorbent Assay (ELISA)
Outcome measures
| Measure |
Placebo Group
n=12 Participants
In this intervention arm Placebo arm received three oral viable capsules daily, containing polysaccharides, without any viable probiotics matching the probiotic capsules in appearance, smell, and taste.
Placebos: The Placebos will be coded in a specific label by a researcher who will not be in contact with the participants and administrated randomly based on gender in a double-blind manner. The patient will receive 2 bottles of the placebo every 2 weeks and will be followed weekly for 6 weeks.
|
Probiotic Group
n=12 Participants
In this intervention arm, the patients will receive oral viable capsules of probiotic contain (1\*10 10 colony-forming unit (CFU)/g) of lactobacillus (Lactobacillus rhamnosus , Lactobacillus acidophilus, Lactobacillus reuteri, Lactobacillus paracasei, Lactobacillus casei, Lactobacillus gasseri, Lactobacillus plantarum) and bifidobacteria (Bifidobacterium lactis, Bifidobacterium breve, Bifidobacterium bifidum, Bifidobacterium longum, Bifidobacterium infantis) species three times a per day
Probiotic Formula Capsule: The Probiotic will be coded in a specific label by a researcher who will not be in contact with the participants and administrated randomly based on gender in a double-blind manner. The patient will receive 2 bottles of the drug every 2 weeks and will be followed weekly for 6 weeks.
|
|---|---|---|
|
The Level of Interleukin (IL)-6
|
10.84 pg/ml
Standard Deviation 3.30
|
9.40 pg/ml
Standard Deviation 3.13
|
PRIMARY outcome
Timeframe: at the end of 6 weeks of follow-upThe Level of Interleukin (IL)-1 in pg/ml measured at the end of follow-up (after 6 weeks of follow-up) by a two-site sandwich Enzyme-Linked Immunosorbent Assay (ELISA)
Outcome measures
| Measure |
Placebo Group
n=12 Participants
In this intervention arm Placebo arm received three oral viable capsules daily, containing polysaccharides, without any viable probiotics matching the probiotic capsules in appearance, smell, and taste.
Placebos: The Placebos will be coded in a specific label by a researcher who will not be in contact with the participants and administrated randomly based on gender in a double-blind manner. The patient will receive 2 bottles of the placebo every 2 weeks and will be followed weekly for 6 weeks.
|
Probiotic Group
n=12 Participants
In this intervention arm, the patients will receive oral viable capsules of probiotic contain (1\*10 10 colony-forming unit (CFU)/g) of lactobacillus (Lactobacillus rhamnosus , Lactobacillus acidophilus, Lactobacillus reuteri, Lactobacillus paracasei, Lactobacillus casei, Lactobacillus gasseri, Lactobacillus plantarum) and bifidobacteria (Bifidobacterium lactis, Bifidobacterium breve, Bifidobacterium bifidum, Bifidobacterium longum, Bifidobacterium infantis) species three times a per day
Probiotic Formula Capsule: The Probiotic will be coded in a specific label by a researcher who will not be in contact with the participants and administrated randomly based on gender in a double-blind manner. The patient will receive 2 bottles of the drug every 2 weeks and will be followed weekly for 6 weeks.
|
|---|---|---|
|
The Level of Interleukin (IL)-1
|
7.33 pg/ml
Standard Deviation 3.31
|
8.55 pg/ml
Standard Deviation 3.45
|
PRIMARY outcome
Timeframe: at the endo f 6 weeks of follow-upThe Level of Interleukin (IL)-10 in pg/ml was measured at the end of follow-up (after 6 weeks of follow-up) by a two-site sandwich Enzyme-Linked Immunosorbent Assay (ELISA)
Outcome measures
| Measure |
Placebo Group
n=12 Participants
In this intervention arm Placebo arm received three oral viable capsules daily, containing polysaccharides, without any viable probiotics matching the probiotic capsules in appearance, smell, and taste.
Placebos: The Placebos will be coded in a specific label by a researcher who will not be in contact with the participants and administrated randomly based on gender in a double-blind manner. The patient will receive 2 bottles of the placebo every 2 weeks and will be followed weekly for 6 weeks.
|
Probiotic Group
n=12 Participants
In this intervention arm, the patients will receive oral viable capsules of probiotic contain (1\*10 10 colony-forming unit (CFU)/g) of lactobacillus (Lactobacillus rhamnosus , Lactobacillus acidophilus, Lactobacillus reuteri, Lactobacillus paracasei, Lactobacillus casei, Lactobacillus gasseri, Lactobacillus plantarum) and bifidobacteria (Bifidobacterium lactis, Bifidobacterium breve, Bifidobacterium bifidum, Bifidobacterium longum, Bifidobacterium infantis) species three times a per day
Probiotic Formula Capsule: The Probiotic will be coded in a specific label by a researcher who will not be in contact with the participants and administrated randomly based on gender in a double-blind manner. The patient will receive 2 bottles of the drug every 2 weeks and will be followed weekly for 6 weeks.
|
|---|---|---|
|
The Level of Interleukin (IL)-10
|
22.89 pg/ml
Standard Deviation 12.49
|
37.10 pg/ml
Standard Deviation 14.95
|
PRIMARY outcome
Timeframe: at the endo of 6weeks of follow-upThe Level of TNF-α in pg/ml measured at the end of follow-up (after 6 weeks of follow-up) by a two-site sandwich Enzyme-Linked Immunosorbent Assay (ELISA)
Outcome measures
| Measure |
Placebo Group
n=12 Participants
In this intervention arm Placebo arm received three oral viable capsules daily, containing polysaccharides, without any viable probiotics matching the probiotic capsules in appearance, smell, and taste.
Placebos: The Placebos will be coded in a specific label by a researcher who will not be in contact with the participants and administrated randomly based on gender in a double-blind manner. The patient will receive 2 bottles of the placebo every 2 weeks and will be followed weekly for 6 weeks.
|
Probiotic Group
n=12 Participants
In this intervention arm, the patients will receive oral viable capsules of probiotic contain (1\*10 10 colony-forming unit (CFU)/g) of lactobacillus (Lactobacillus rhamnosus , Lactobacillus acidophilus, Lactobacillus reuteri, Lactobacillus paracasei, Lactobacillus casei, Lactobacillus gasseri, Lactobacillus plantarum) and bifidobacteria (Bifidobacterium lactis, Bifidobacterium breve, Bifidobacterium bifidum, Bifidobacterium longum, Bifidobacterium infantis) species three times a per day
Probiotic Formula Capsule: The Probiotic will be coded in a specific label by a researcher who will not be in contact with the participants and administrated randomly based on gender in a double-blind manner. The patient will receive 2 bottles of the drug every 2 weeks and will be followed weekly for 6 weeks.
|
|---|---|---|
|
The Level of Tumor Necrosis Factor (TNF)-α
|
9.36 pg/ml
Standard Deviation 1.57
|
9.58 pg/ml
Standard Deviation 1.75
|
PRIMARY outcome
Timeframe: at the end of 6 weeks of follow-upThe Level of CRP in mg/ml measured at the end of follow-up (after 6 weeks of follow-up) based on an Immunoturbidimetric assay using Cobas-C501
Outcome measures
| Measure |
Placebo Group
n=12 Participants
In this intervention arm Placebo arm received three oral viable capsules daily, containing polysaccharides, without any viable probiotics matching the probiotic capsules in appearance, smell, and taste.
Placebos: The Placebos will be coded in a specific label by a researcher who will not be in contact with the participants and administrated randomly based on gender in a double-blind manner. The patient will receive 2 bottles of the placebo every 2 weeks and will be followed weekly for 6 weeks.
|
Probiotic Group
n=12 Participants
In this intervention arm, the patients will receive oral viable capsules of probiotic contain (1\*10 10 colony-forming unit (CFU)/g) of lactobacillus (Lactobacillus rhamnosus , Lactobacillus acidophilus, Lactobacillus reuteri, Lactobacillus paracasei, Lactobacillus casei, Lactobacillus gasseri, Lactobacillus plantarum) and bifidobacteria (Bifidobacterium lactis, Bifidobacterium breve, Bifidobacterium bifidum, Bifidobacterium longum, Bifidobacterium infantis) species three times a per day
Probiotic Formula Capsule: The Probiotic will be coded in a specific label by a researcher who will not be in contact with the participants and administrated randomly based on gender in a double-blind manner. The patient will receive 2 bottles of the drug every 2 weeks and will be followed weekly for 6 weeks.
|
|---|---|---|
|
The Level of C-reactive Protein (CRP)
|
4.65 mg/L
Standard Deviation 0.24
|
4.54 mg/L
Standard Deviation 0.14
|
SECONDARY outcome
Timeframe: at the end of 6 weeks of follow-upThe average score of the general quality of life (QoL) subscales was assessed by the Short Quality of Life in Inflammatory Bowel Disease Questionnaire (SIBDQ). The SIBDQ contains 10 questions for 4 functional scales (Bowel, Systemic, emotional, and social). For each question, there a regraded responses on a 7-point Likert scale ranging from one (representing the ''worst'' aspect) to seven (representing the ''best'' aspect). Total SIBDQ scores range from 10 to 70.Higher scores reflect better well-being.
Outcome measures
| Measure |
Placebo Group
n=12 Participants
In this intervention arm Placebo arm received three oral viable capsules daily, containing polysaccharides, without any viable probiotics matching the probiotic capsules in appearance, smell, and taste.
Placebos: The Placebos will be coded in a specific label by a researcher who will not be in contact with the participants and administrated randomly based on gender in a double-blind manner. The patient will receive 2 bottles of the placebo every 2 weeks and will be followed weekly for 6 weeks.
|
Probiotic Group
n=12 Participants
In this intervention arm, the patients will receive oral viable capsules of probiotic contain (1\*10 10 colony-forming unit (CFU)/g) of lactobacillus (Lactobacillus rhamnosus , Lactobacillus acidophilus, Lactobacillus reuteri, Lactobacillus paracasei, Lactobacillus casei, Lactobacillus gasseri, Lactobacillus plantarum) and bifidobacteria (Bifidobacterium lactis, Bifidobacterium breve, Bifidobacterium bifidum, Bifidobacterium longum, Bifidobacterium infantis) species three times a per day
Probiotic Formula Capsule: The Probiotic will be coded in a specific label by a researcher who will not be in contact with the participants and administrated randomly based on gender in a double-blind manner. The patient will receive 2 bottles of the drug every 2 weeks and will be followed weekly for 6 weeks.
|
|---|---|---|
|
Quality of Life of Patients
|
4.96 points
Standard Deviation 1.27
|
6.54 points
Standard Deviation 0.29
|
OTHER_PRE_SPECIFIED outcome
Timeframe: at the end of 6 weeks of follow-upThe level of WBC as cells\*10\^9/l measured at the end of follow-up (after 6 weeks of follow-up) using the automated analyzer Sysmex XS-500i
Outcome measures
| Measure |
Placebo Group
n=12 Participants
In this intervention arm Placebo arm received three oral viable capsules daily, containing polysaccharides, without any viable probiotics matching the probiotic capsules in appearance, smell, and taste.
Placebos: The Placebos will be coded in a specific label by a researcher who will not be in contact with the participants and administrated randomly based on gender in a double-blind manner. The patient will receive 2 bottles of the placebo every 2 weeks and will be followed weekly for 6 weeks.
|
Probiotic Group
n=12 Participants
In this intervention arm, the patients will receive oral viable capsules of probiotic contain (1\*10 10 colony-forming unit (CFU)/g) of lactobacillus (Lactobacillus rhamnosus , Lactobacillus acidophilus, Lactobacillus reuteri, Lactobacillus paracasei, Lactobacillus casei, Lactobacillus gasseri, Lactobacillus plantarum) and bifidobacteria (Bifidobacterium lactis, Bifidobacterium breve, Bifidobacterium bifidum, Bifidobacterium longum, Bifidobacterium infantis) species three times a per day
Probiotic Formula Capsule: The Probiotic will be coded in a specific label by a researcher who will not be in contact with the participants and administrated randomly based on gender in a double-blind manner. The patient will receive 2 bottles of the drug every 2 weeks and will be followed weekly for 6 weeks.
|
|---|---|---|
|
The Level of White Blood Cell Count (WBC)
|
8.18 cells10^9/l
Standard Deviation 2.90
|
6.72 cells10^9/l
Standard Deviation 2.01
|
OTHER_PRE_SPECIFIED outcome
Timeframe: at the end of 6 weeks of follow-upThe level of RBC as cells\*10\^12/l measured at the end of follow-up (after 6 weeks of follow-up) using the automated analyzer Sysmex XS-500i
Outcome measures
| Measure |
Placebo Group
n=12 Participants
In this intervention arm Placebo arm received three oral viable capsules daily, containing polysaccharides, without any viable probiotics matching the probiotic capsules in appearance, smell, and taste.
Placebos: The Placebos will be coded in a specific label by a researcher who will not be in contact with the participants and administrated randomly based on gender in a double-blind manner. The patient will receive 2 bottles of the placebo every 2 weeks and will be followed weekly for 6 weeks.
|
Probiotic Group
n=12 Participants
In this intervention arm, the patients will receive oral viable capsules of probiotic contain (1\*10 10 colony-forming unit (CFU)/g) of lactobacillus (Lactobacillus rhamnosus , Lactobacillus acidophilus, Lactobacillus reuteri, Lactobacillus paracasei, Lactobacillus casei, Lactobacillus gasseri, Lactobacillus plantarum) and bifidobacteria (Bifidobacterium lactis, Bifidobacterium breve, Bifidobacterium bifidum, Bifidobacterium longum, Bifidobacterium infantis) species three times a per day
Probiotic Formula Capsule: The Probiotic will be coded in a specific label by a researcher who will not be in contact with the participants and administrated randomly based on gender in a double-blind manner. The patient will receive 2 bottles of the drug every 2 weeks and will be followed weekly for 6 weeks.
|
|---|---|---|
|
The Level of Red Blood Cell Count (RBC)
|
4.73 cells10^12/ul
Standard Deviation 0.55
|
4.95 cells10^12/ul
Standard Deviation 0.36
|
OTHER_PRE_SPECIFIED outcome
Timeframe: at the end of 6 weeks of follow-upThe MCV in fl measured at the end of follow-up (after 6 weeks of follow-up) using the automated analyzer Sysmex XS-500i
Outcome measures
| Measure |
Placebo Group
n=12 Participants
In this intervention arm Placebo arm received three oral viable capsules daily, containing polysaccharides, without any viable probiotics matching the probiotic capsules in appearance, smell, and taste.
Placebos: The Placebos will be coded in a specific label by a researcher who will not be in contact with the participants and administrated randomly based on gender in a double-blind manner. The patient will receive 2 bottles of the placebo every 2 weeks and will be followed weekly for 6 weeks.
|
Probiotic Group
n=12 Participants
In this intervention arm, the patients will receive oral viable capsules of probiotic contain (1\*10 10 colony-forming unit (CFU)/g) of lactobacillus (Lactobacillus rhamnosus , Lactobacillus acidophilus, Lactobacillus reuteri, Lactobacillus paracasei, Lactobacillus casei, Lactobacillus gasseri, Lactobacillus plantarum) and bifidobacteria (Bifidobacterium lactis, Bifidobacterium breve, Bifidobacterium bifidum, Bifidobacterium longum, Bifidobacterium infantis) species three times a per day
Probiotic Formula Capsule: The Probiotic will be coded in a specific label by a researcher who will not be in contact with the participants and administrated randomly based on gender in a double-blind manner. The patient will receive 2 bottles of the drug every 2 weeks and will be followed weekly for 6 weeks.
|
|---|---|---|
|
The Mean Corpuscular Volume (MCV)
|
85.68 fl
Standard Deviation 9.23
|
83.63 fl
Standard Deviation 7.33
|
OTHER_PRE_SPECIFIED outcome
Timeframe: at the end of 6 weeks of follow-upThe MCH in pg measured at the end of follow-up (after 6 weeks of follow-up) using the automated analyzer Sysmex XS-500i
Outcome measures
| Measure |
Placebo Group
n=12 Participants
In this intervention arm Placebo arm received three oral viable capsules daily, containing polysaccharides, without any viable probiotics matching the probiotic capsules in appearance, smell, and taste.
Placebos: The Placebos will be coded in a specific label by a researcher who will not be in contact with the participants and administrated randomly based on gender in a double-blind manner. The patient will receive 2 bottles of the placebo every 2 weeks and will be followed weekly for 6 weeks.
|
Probiotic Group
n=12 Participants
In this intervention arm, the patients will receive oral viable capsules of probiotic contain (1\*10 10 colony-forming unit (CFU)/g) of lactobacillus (Lactobacillus rhamnosus , Lactobacillus acidophilus, Lactobacillus reuteri, Lactobacillus paracasei, Lactobacillus casei, Lactobacillus gasseri, Lactobacillus plantarum) and bifidobacteria (Bifidobacterium lactis, Bifidobacterium breve, Bifidobacterium bifidum, Bifidobacterium longum, Bifidobacterium infantis) species three times a per day
Probiotic Formula Capsule: The Probiotic will be coded in a specific label by a researcher who will not be in contact with the participants and administrated randomly based on gender in a double-blind manner. The patient will receive 2 bottles of the drug every 2 weeks and will be followed weekly for 6 weeks.
|
|---|---|---|
|
The Mean Corpuscular Hemoglobin (MCH)
|
28.70 pg
Standard Deviation 3.27
|
27.88 pg
Standard Deviation 2.96
|
OTHER_PRE_SPECIFIED outcome
Timeframe: at the end of 6 weeks of follow-upThe MCH in g/dl measured at the end of follow-up (after 6 weeks of follow-up) using the automated analyzer Sysmex XS-500i
Outcome measures
| Measure |
Placebo Group
n=12 Participants
In this intervention arm Placebo arm received three oral viable capsules daily, containing polysaccharides, without any viable probiotics matching the probiotic capsules in appearance, smell, and taste.
Placebos: The Placebos will be coded in a specific label by a researcher who will not be in contact with the participants and administrated randomly based on gender in a double-blind manner. The patient will receive 2 bottles of the placebo every 2 weeks and will be followed weekly for 6 weeks.
|
Probiotic Group
n=12 Participants
In this intervention arm, the patients will receive oral viable capsules of probiotic contain (1\*10 10 colony-forming unit (CFU)/g) of lactobacillus (Lactobacillus rhamnosus , Lactobacillus acidophilus, Lactobacillus reuteri, Lactobacillus paracasei, Lactobacillus casei, Lactobacillus gasseri, Lactobacillus plantarum) and bifidobacteria (Bifidobacterium lactis, Bifidobacterium breve, Bifidobacterium bifidum, Bifidobacterium longum, Bifidobacterium infantis) species three times a per day
Probiotic Formula Capsule: The Probiotic will be coded in a specific label by a researcher who will not be in contact with the participants and administrated randomly based on gender in a double-blind manner. The patient will receive 2 bottles of the drug every 2 weeks and will be followed weekly for 6 weeks.
|
|---|---|---|
|
The Mean Corpuscular Hemoglobin Concentration (MCHC)
|
33.28 g/dl
Standard Deviation 0.90
|
33.52 g/dl
Standard Deviation 1.31
|
OTHER_PRE_SPECIFIED outcome
Timeframe: at the end of 6 weeks of follow-upThe Platelet count as cells 10\^9/ll measured at the end of follow-up (after 6 weeks of follow-up) using the automated analyzer Sysmex XS-500i
Outcome measures
| Measure |
Placebo Group
n=12 Participants
In this intervention arm Placebo arm received three oral viable capsules daily, containing polysaccharides, without any viable probiotics matching the probiotic capsules in appearance, smell, and taste.
Placebos: The Placebos will be coded in a specific label by a researcher who will not be in contact with the participants and administrated randomly based on gender in a double-blind manner. The patient will receive 2 bottles of the placebo every 2 weeks and will be followed weekly for 6 weeks.
|
Probiotic Group
n=12 Participants
In this intervention arm, the patients will receive oral viable capsules of probiotic contain (1\*10 10 colony-forming unit (CFU)/g) of lactobacillus (Lactobacillus rhamnosus , Lactobacillus acidophilus, Lactobacillus reuteri, Lactobacillus paracasei, Lactobacillus casei, Lactobacillus gasseri, Lactobacillus plantarum) and bifidobacteria (Bifidobacterium lactis, Bifidobacterium breve, Bifidobacterium bifidum, Bifidobacterium longum, Bifidobacterium infantis) species three times a per day
Probiotic Formula Capsule: The Probiotic will be coded in a specific label by a researcher who will not be in contact with the participants and administrated randomly based on gender in a double-blind manner. The patient will receive 2 bottles of the drug every 2 weeks and will be followed weekly for 6 weeks.
|
|---|---|---|
|
The Platelet Count
|
292.40 cells*10^9/l
Standard Deviation 72.05
|
288.18 cells*10^9/l
Standard Deviation 69.47
|
OTHER_PRE_SPECIFIED outcome
Timeframe: at the end of 6 weeks of follow-upThe Hemoglobin in g/dl measured at the end of follow-up (after 6 weeks of follow-up) using the automated analyzer Sysmex XS-500i
Outcome measures
| Measure |
Placebo Group
n=12 Participants
In this intervention arm Placebo arm received three oral viable capsules daily, containing polysaccharides, without any viable probiotics matching the probiotic capsules in appearance, smell, and taste.
Placebos: The Placebos will be coded in a specific label by a researcher who will not be in contact with the participants and administrated randomly based on gender in a double-blind manner. The patient will receive 2 bottles of the placebo every 2 weeks and will be followed weekly for 6 weeks.
|
Probiotic Group
n=12 Participants
In this intervention arm, the patients will receive oral viable capsules of probiotic contain (1\*10 10 colony-forming unit (CFU)/g) of lactobacillus (Lactobacillus rhamnosus , Lactobacillus acidophilus, Lactobacillus reuteri, Lactobacillus paracasei, Lactobacillus casei, Lactobacillus gasseri, Lactobacillus plantarum) and bifidobacteria (Bifidobacterium lactis, Bifidobacterium breve, Bifidobacterium bifidum, Bifidobacterium longum, Bifidobacterium infantis) species three times a per day
Probiotic Formula Capsule: The Probiotic will be coded in a specific label by a researcher who will not be in contact with the participants and administrated randomly based on gender in a double-blind manner. The patient will receive 2 bottles of the drug every 2 weeks and will be followed weekly for 6 weeks.
|
|---|---|---|
|
The of Hemoglobin
|
13.54 g/l
Standard Deviation 2.01
|
13.78 g/l
Standard Deviation 1.54
|
OTHER_PRE_SPECIFIED outcome
Timeframe: at the end of 6 weeks of follow-upThe MPV in fl measured at the end of follow-up (after 6 weeks of follow-up) using the automated analyzer Sysmex XS-500i
Outcome measures
| Measure |
Placebo Group
n=12 Participants
In this intervention arm Placebo arm received three oral viable capsules daily, containing polysaccharides, without any viable probiotics matching the probiotic capsules in appearance, smell, and taste.
Placebos: The Placebos will be coded in a specific label by a researcher who will not be in contact with the participants and administrated randomly based on gender in a double-blind manner. The patient will receive 2 bottles of the placebo every 2 weeks and will be followed weekly for 6 weeks.
|
Probiotic Group
n=12 Participants
In this intervention arm, the patients will receive oral viable capsules of probiotic contain (1\*10 10 colony-forming unit (CFU)/g) of lactobacillus (Lactobacillus rhamnosus , Lactobacillus acidophilus, Lactobacillus reuteri, Lactobacillus paracasei, Lactobacillus casei, Lactobacillus gasseri, Lactobacillus plantarum) and bifidobacteria (Bifidobacterium lactis, Bifidobacterium breve, Bifidobacterium bifidum, Bifidobacterium longum, Bifidobacterium infantis) species three times a per day
Probiotic Formula Capsule: The Probiotic will be coded in a specific label by a researcher who will not be in contact with the participants and administrated randomly based on gender in a double-blind manner. The patient will receive 2 bottles of the drug every 2 weeks and will be followed weekly for 6 weeks.
|
|---|---|---|
|
The Mean Platelet Volume (MPV)
|
10.67 fl
Standard Deviation 1.22
|
10.71 fl
Standard Deviation 0.83
|
OTHER_PRE_SPECIFIED outcome
Timeframe: at the end of 6 weeks of follow-upThe number of lymphocytes cells as cells\*10\^9/L measuredat the end of follow-up (after 6 weeks of follow-up) using the automated analyzer Sysmex XS-500i
Outcome measures
| Measure |
Placebo Group
n=12 Participants
In this intervention arm Placebo arm received three oral viable capsules daily, containing polysaccharides, without any viable probiotics matching the probiotic capsules in appearance, smell, and taste.
Placebos: The Placebos will be coded in a specific label by a researcher who will not be in contact with the participants and administrated randomly based on gender in a double-blind manner. The patient will receive 2 bottles of the placebo every 2 weeks and will be followed weekly for 6 weeks.
|
Probiotic Group
n=12 Participants
In this intervention arm, the patients will receive oral viable capsules of probiotic contain (1\*10 10 colony-forming unit (CFU)/g) of lactobacillus (Lactobacillus rhamnosus , Lactobacillus acidophilus, Lactobacillus reuteri, Lactobacillus paracasei, Lactobacillus casei, Lactobacillus gasseri, Lactobacillus plantarum) and bifidobacteria (Bifidobacterium lactis, Bifidobacterium breve, Bifidobacterium bifidum, Bifidobacterium longum, Bifidobacterium infantis) species three times a per day
Probiotic Formula Capsule: The Probiotic will be coded in a specific label by a researcher who will not be in contact with the participants and administrated randomly based on gender in a double-blind manner. The patient will receive 2 bottles of the drug every 2 weeks and will be followed weekly for 6 weeks.
|
|---|---|---|
|
The Level of Lymphocytes
|
2.50 cells*10^9/L
Standard Deviation 0.93
|
2.40 cells*10^9/L
Standard Deviation 0.69
|
OTHER_PRE_SPECIFIED outcome
Timeframe: at the end of 6 weeks of follow-upThe number of Monocytes cells measured at the end of follow-up (after 6 weeks of follow-up) using the automated analyzer Sysmex XS-500i
Outcome measures
| Measure |
Placebo Group
n=12 Participants
In this intervention arm Placebo arm received three oral viable capsules daily, containing polysaccharides, without any viable probiotics matching the probiotic capsules in appearance, smell, and taste.
Placebos: The Placebos will be coded in a specific label by a researcher who will not be in contact with the participants and administrated randomly based on gender in a double-blind manner. The patient will receive 2 bottles of the placebo every 2 weeks and will be followed weekly for 6 weeks.
|
Probiotic Group
n=12 Participants
In this intervention arm, the patients will receive oral viable capsules of probiotic contain (1\*10 10 colony-forming unit (CFU)/g) of lactobacillus (Lactobacillus rhamnosus , Lactobacillus acidophilus, Lactobacillus reuteri, Lactobacillus paracasei, Lactobacillus casei, Lactobacillus gasseri, Lactobacillus plantarum) and bifidobacteria (Bifidobacterium lactis, Bifidobacterium breve, Bifidobacterium bifidum, Bifidobacterium longum, Bifidobacterium infantis) species three times a per day
Probiotic Formula Capsule: The Probiotic will be coded in a specific label by a researcher who will not be in contact with the participants and administrated randomly based on gender in a double-blind manner. The patient will receive 2 bottles of the drug every 2 weeks and will be followed weekly for 6 weeks.
|
|---|---|---|
|
The Level of Monocytes
|
0.67 cells10^9/l
Standard Deviation 0.28
|
0.59 cells10^9/l
Standard Deviation 0.16
|
OTHER_PRE_SPECIFIED outcome
Timeframe: at the end of 6 weeks of follow-upThe number of eosinophils cells measured at the end of follow-up (after 6 weeks of follow-up) using the automated analyzer Sysmex XS-500i
Outcome measures
| Measure |
Placebo Group
n=12 Participants
In this intervention arm Placebo arm received three oral viable capsules daily, containing polysaccharides, without any viable probiotics matching the probiotic capsules in appearance, smell, and taste.
Placebos: The Placebos will be coded in a specific label by a researcher who will not be in contact with the participants and administrated randomly based on gender in a double-blind manner. The patient will receive 2 bottles of the placebo every 2 weeks and will be followed weekly for 6 weeks.
|
Probiotic Group
n=12 Participants
In this intervention arm, the patients will receive oral viable capsules of probiotic contain (1\*10 10 colony-forming unit (CFU)/g) of lactobacillus (Lactobacillus rhamnosus , Lactobacillus acidophilus, Lactobacillus reuteri, Lactobacillus paracasei, Lactobacillus casei, Lactobacillus gasseri, Lactobacillus plantarum) and bifidobacteria (Bifidobacterium lactis, Bifidobacterium breve, Bifidobacterium bifidum, Bifidobacterium longum, Bifidobacterium infantis) species three times a per day
Probiotic Formula Capsule: The Probiotic will be coded in a specific label by a researcher who will not be in contact with the participants and administrated randomly based on gender in a double-blind manner. The patient will receive 2 bottles of the drug every 2 weeks and will be followed weekly for 6 weeks.
|
|---|---|---|
|
The Level of Eosinophils
|
0.25 cells10^9/l
Standard Deviation 0.19
|
0.15 cells10^9/l
Standard Deviation 0.10
|
OTHER_PRE_SPECIFIED outcome
Timeframe: at the end of 6 weeks of follow-upThe number of basophils cells measured at the end of follow-up (after 6 weeks of follow-up) using the automated analyzer Sysmex XS-500i
Outcome measures
| Measure |
Placebo Group
n=12 Participants
In this intervention arm Placebo arm received three oral viable capsules daily, containing polysaccharides, without any viable probiotics matching the probiotic capsules in appearance, smell, and taste.
Placebos: The Placebos will be coded in a specific label by a researcher who will not be in contact with the participants and administrated randomly based on gender in a double-blind manner. The patient will receive 2 bottles of the placebo every 2 weeks and will be followed weekly for 6 weeks.
|
Probiotic Group
n=12 Participants
In this intervention arm, the patients will receive oral viable capsules of probiotic contain (1\*10 10 colony-forming unit (CFU)/g) of lactobacillus (Lactobacillus rhamnosus , Lactobacillus acidophilus, Lactobacillus reuteri, Lactobacillus paracasei, Lactobacillus casei, Lactobacillus gasseri, Lactobacillus plantarum) and bifidobacteria (Bifidobacterium lactis, Bifidobacterium breve, Bifidobacterium bifidum, Bifidobacterium longum, Bifidobacterium infantis) species three times a per day
Probiotic Formula Capsule: The Probiotic will be coded in a specific label by a researcher who will not be in contact with the participants and administrated randomly based on gender in a double-blind manner. The patient will receive 2 bottles of the drug every 2 weeks and will be followed weekly for 6 weeks.
|
|---|---|---|
|
The Level of Basophils
|
0 cells10^9/l
Standard Deviation 0
|
0 cells10^9/l
Standard Deviation 0
|
OTHER_PRE_SPECIFIED outcome
Timeframe: at the end of 6 weeks of follow-upThe number of neutrophils cells measured at the end of follow-up (after 6 weeks of follow-up) using the automated analyzer Sysmex XS-500i
Outcome measures
| Measure |
Placebo Group
n=12 Participants
In this intervention arm Placebo arm received three oral viable capsules daily, containing polysaccharides, without any viable probiotics matching the probiotic capsules in appearance, smell, and taste.
Placebos: The Placebos will be coded in a specific label by a researcher who will not be in contact with the participants and administrated randomly based on gender in a double-blind manner. The patient will receive 2 bottles of the placebo every 2 weeks and will be followed weekly for 6 weeks.
|
Probiotic Group
n=12 Participants
In this intervention arm, the patients will receive oral viable capsules of probiotic contain (1\*10 10 colony-forming unit (CFU)/g) of lactobacillus (Lactobacillus rhamnosus , Lactobacillus acidophilus, Lactobacillus reuteri, Lactobacillus paracasei, Lactobacillus casei, Lactobacillus gasseri, Lactobacillus plantarum) and bifidobacteria (Bifidobacterium lactis, Bifidobacterium breve, Bifidobacterium bifidum, Bifidobacterium longum, Bifidobacterium infantis) species three times a per day
Probiotic Formula Capsule: The Probiotic will be coded in a specific label by a researcher who will not be in contact with the participants and administrated randomly based on gender in a double-blind manner. The patient will receive 2 bottles of the drug every 2 weeks and will be followed weekly for 6 weeks.
|
|---|---|---|
|
The Level of Neutrophils
|
5.05 cells10^9/l
Standard Deviation 2.35
|
3.56 cells10^9/l
Standard Deviation 1.59
|
Adverse Events
Probiotic Formula Capsule
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Placebos
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place