Trial Outcomes & Findings for Probiotics and Antibiotic Associated Diarrhea in Pediatric Complicated Appendicitis (NCT NCT04529980)
NCT ID: NCT04529980
Last Updated: 2024-08-13
Results Overview
Length of hospital stay measured in hours from admission to discharge. from admission to discharge, up to 1 month
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
98 participants
Primary outcome timeframe
From admission to discharge, up to 1 month
Results posted on
2024-08-13
Participant Flow
Participant milestones
| Measure |
Lactobacillus Rhanmosus GG(LGG®) Group
Lactobacillus rhanmosus GG(LGG®)(Culturelle) is an over the counter dietary supplement that can help to restore the balance in the gut by promoting colonization to support better digestion and immune health. As such, this dietary supplement is not reviewed and approved by the FDA. This study does not intend to investigate route of administration, dose, patient population, or other factor that significantly increases the risk (or decreases the acceptability of the risk) associated with the use of the dietary supplement. Patients in the treatment group will receive a standard dose of Lactobacillus rhamnosus GG capsule following their surgery while in the hospital until discharge.
Lactobacillus rhamnosus GG (LGG) Probiotic: Lactobacillus rhanmosus GG(LGG®)(Culturelle) is an over the counter dietary supplement that can help to restore the balance in the gut by promoting colonization to support better digestion and immune health.
|
Placebo Control Group
Patients in the placebo group will receive a placebo capsule following their surgery while in the hospital until discharge.
Placebo: Placebo
|
|---|---|---|
|
Overall Study
STARTED
|
57
|
41
|
|
Overall Study
COMPLETED
|
53
|
40
|
|
Overall Study
NOT COMPLETED
|
4
|
1
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Probiotics and Antibiotic Associated Diarrhea in Pediatric Complicated Appendicitis
Baseline characteristics by cohort
| Measure |
Lactobacillus Rhanmosus GG(LGG®) Group
n=53 Participants
Lactobacillus rhanmosus GG(LGG®)(Culturelle) is an over the counter dietary supplement that can help to restore the balance in the gut by promoting colonization to support better digestion and immune health. As such, this dietary supplement is not reviewed and approved by the FDA. This study does not intend to investigate route of administration, dose, patient population, or other factor that significantly increases the risk (or decreases the acceptability of the risk) associated with the use of the dietary supplement. Patients in the treatment group will receive a standard dose of Lactobacillus rhamnosus GG capsule following their surgery while in the hospital until discharge.
Lactobacillus rhamnosus GG (LGG) Probiotic: Lactobacillus rhanmosus GG(LGG®)(Culturelle) is an over the counter dietary supplement that can help to restore the balance in the gut by promoting colonization to support better digestion and immune health.
|
Placebo Control Group
n=40 Participants
Patients in the placebo group will receive a placebo capsule following their surgery while in the hospital until discharge.
Placebo: Placebo
|
Total
n=93 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
53 Participants
n=5 Participants
|
40 Participants
n=7 Participants
|
93 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Continuous
|
10.23 years
STANDARD_DEVIATION 3.51 • n=5 Participants
|
10.53 years
STANDARD_DEVIATION 3.94 • n=7 Participants
|
10.29 years
STANDARD_DEVIATION 3.65 • n=5 Participants
|
|
Sex: Female, Male
Female
|
20 Participants
n=5 Participants
|
23 Participants
n=7 Participants
|
43 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
33 Participants
n=5 Participants
|
17 Participants
n=7 Participants
|
50 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
36 Participants
n=5 Participants
|
29 Participants
n=7 Participants
|
65 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
16 Participants
n=5 Participants
|
11 Participants
n=7 Participants
|
27 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 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
|
3 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
3 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
|
4 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
45 Participants
n=5 Participants
|
38 Participants
n=7 Participants
|
83 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
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
53 Participants
n=5 Participants
|
40 Participants
n=7 Participants
|
93 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: From admission to discharge, up to 1 monthLength of hospital stay measured in hours from admission to discharge. from admission to discharge, up to 1 month
Outcome measures
| Measure |
Lactobacillus Rhanmosus GG(LGG®) Group
n=53 Participants
Lactobacillus rhanmosus GG(LGG®)(Culturelle) is an over the counter dietary supplement that can help to restore the balance in the gut by promoting colonization to support better digestion and immune health. As such, this dietary supplement is not reviewed and approved by the FDA. This study does not intend to investigate route of administration, dose, patient population, or other factor that significantly increases the risk (or decreases the acceptability of the risk) associated with the use of the dietary supplement. Patients in the treatment group will receive a standard dose of Lactobacillus rhamnosus GG capsule following their surgery while in the hospital until discharge.
Lactobacillus rhamnosus GG (LGG) Probiotic: Lactobacillus rhanmosus GG(LGG®)(Culturelle) is an over the counter dietary supplement that can help to restore the balance in the gut by promoting colonization to support better digestion and immune health.
|
Placebo Control Group
n=40 Participants
Patients in the placebo group will receive a placebo capsule following their surgery while in the hospital until discharge.
Placebo: Placebo
|
|---|---|---|
|
Length of Hospital Stay
|
121.55 hours
Standard Deviation 59.21
|
131.69 hours
Standard Deviation 74.27
|
SECONDARY outcome
Timeframe: up to 1 monthDocumented number of diarrhea episodes each day in EHR.
Outcome measures
| Measure |
Lactobacillus Rhanmosus GG(LGG®) Group
n=53 Participants
Lactobacillus rhanmosus GG(LGG®)(Culturelle) is an over the counter dietary supplement that can help to restore the balance in the gut by promoting colonization to support better digestion and immune health. As such, this dietary supplement is not reviewed and approved by the FDA. This study does not intend to investigate route of administration, dose, patient population, or other factor that significantly increases the risk (or decreases the acceptability of the risk) associated with the use of the dietary supplement. Patients in the treatment group will receive a standard dose of Lactobacillus rhamnosus GG capsule following their surgery while in the hospital until discharge.
Lactobacillus rhamnosus GG (LGG) Probiotic: Lactobacillus rhanmosus GG(LGG®)(Culturelle) is an over the counter dietary supplement that can help to restore the balance in the gut by promoting colonization to support better digestion and immune health.
|
Placebo Control Group
n=40 Participants
Patients in the placebo group will receive a placebo capsule following their surgery while in the hospital until discharge.
Placebo: Placebo
|
|---|---|---|
|
Number of Diarrhea Episodes Daily
|
12.43 episodes/day
Standard Deviation 15.51
|
9.50 episodes/day
Standard Deviation 11.05
|
Adverse Events
Lactobacillus Rhanmosus GG(LGG®) Group
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Placebo Control Group
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
Dr. Mayra Garcia, DNP, APRN, PCNS-BC, EBP-C
Children's Health Children's Medical Center
Phone: 12144567990
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place