Trial Outcomes & Findings for Fermented Milk Drink on Human Intestinal Microflora (NCT NCT00822328)
NCT ID: NCT00822328
Last Updated: 2009-09-02
Results Overview
Fecal specimens were obtained from all 24 healthy volunteers at week 0, 1, 2, 3, 4, 5, 6. Bifidobacterium was cultured. Bacterial colonies were counted.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
24 participants
Primary outcome timeframe
week 0, 1, 2, 3, 4, 5, 6.
Results posted on
2009-09-02
Participant Flow
24 healthy volunteers were recuited on Jan.11, 2009 at Cheng Hsin Rehabilitation Medical Center.
Participant milestones
| Measure |
Fermented Milk (Study Group)
Fermented milk with Lactobacillus casei strain Shirota 100ml per day
|
Unfermented Milk (Placebo Group)
Unfermented milk without Lactobacillus casei strain Shirota 100ml per day
|
|---|---|---|
|
Overall Study
STARTED
|
12
|
12
|
|
Overall Study
COMPLETED
|
12
|
12
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Fermented Milk Drink on Human Intestinal Microflora
Baseline characteristics by cohort
| Measure |
Fermented Milk (Study Group)
n=12 Participants
Fermented milk with Lactobacillus casei strain Shirota 100ml per day
|
Unfermented Milk (Placebo Group)
n=12 Participants
Unfermented milk without Lactobacillus casei strain Shirota 100ml per day
|
Total
n=24 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
|
12 Participants
n=5 Participants
|
12 Participants
n=7 Participants
|
24 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
|
30.00 years
STANDARD_DEVIATION 3.54 • n=5 Participants
|
32.42 years
STANDARD_DEVIATION 6.33 • n=7 Participants
|
31.21 years
STANDARD_DEVIATION 5.17 • n=5 Participants
|
|
Sex: Female, Male
Female
|
8 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
14 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
4 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
10 Participants
n=5 Participants
|
|
Region of Enrollment
Taiwan
|
12 participants
n=5 Participants
|
12 participants
n=7 Participants
|
24 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: week 0, 1, 2, 3, 4, 5, 6.Population: The number of participants for analysis was per protocol analysis.
Fecal specimens were obtained from all 24 healthy volunteers at week 0, 1, 2, 3, 4, 5, 6. Bifidobacterium was cultured. Bacterial colonies were counted.
Outcome measures
| Measure |
Fermented Milk (Study Group)
n=12 Participants
Fermented milk with Lactobacillus casei strain Shirota 100ml per day
|
Unfermented Milk (Placebo Group)
n=12 Participants
Unfermented milk without Lactobacillus casei strain Shirota 100ml per day
|
|---|---|---|
|
Modification of the Composition of the Intestinal Microflora: Bifidobacterium
Week 1
|
8.13 log10 CFU/g
Standard Deviation 0.49
|
8.10 log10 CFU/g
Standard Deviation 0.78
|
|
Modification of the Composition of the Intestinal Microflora: Bifidobacterium
Week 2
|
9.03 log10 CFU/g
Standard Deviation 0.76
|
8.35 log10 CFU/g
Standard Deviation 0.59
|
|
Modification of the Composition of the Intestinal Microflora: Bifidobacterium
Week 3
|
8.87 log10 CFU/g
Standard Deviation 0.88
|
8.11 log10 CFU/g
Standard Deviation 0.82
|
|
Modification of the Composition of the Intestinal Microflora: Bifidobacterium
Week 4
|
9.43 log10 CFU/g
Standard Deviation 0.29
|
8.40 log10 CFU/g
Standard Deviation 0.52
|
|
Modification of the Composition of the Intestinal Microflora: Bifidobacterium
Week 0
|
7.88 log10 CFU/g
Standard Deviation 0.41
|
7.60 log10 CFU/g
Standard Deviation 0.63
|
|
Modification of the Composition of the Intestinal Microflora: Bifidobacterium
Week 5
|
9.14 log10 CFU/g
Standard Deviation 0.45
|
8.27 log10 CFU/g
Standard Deviation 0.44
|
|
Modification of the Composition of the Intestinal Microflora: Bifidobacterium
Week 6
|
8.51 log10 CFU/g
Standard Deviation 0.41
|
8.05 log10 CFU/g
Standard Deviation 0.63
|
PRIMARY outcome
Timeframe: week 0, 1, 2, 3, 4, 5, 6.Fecal specimens were obtained from all 24 healthy volunteers at week 0, 1, 2, 3, 4, 5, 6. Clostridium perfringens was cultured.Bacterial colonies were counted.
Outcome measures
| Measure |
Fermented Milk (Study Group)
n=12 Participants
Fermented milk with Lactobacillus casei strain Shirota 100ml per day
|
Unfermented Milk (Placebo Group)
n=12 Participants
Unfermented milk without Lactobacillus casei strain Shirota 100ml per day
|
|---|---|---|
|
Modification of the Composition of the Intestinal Microflora: Clostridium Perfringens
Week 0
|
7.13 log10 CFU/g
Standard Deviation 0.66
|
7.24 log10 CFU/g
Standard Deviation 0.59
|
|
Modification of the Composition of the Intestinal Microflora: Clostridium Perfringens
Week 1
|
7.61 log10 CFU/g
Standard Deviation 0.61
|
7.57 log10 CFU/g
Standard Deviation 0.57
|
|
Modification of the Composition of the Intestinal Microflora: Clostridium Perfringens
Week 2
|
8.04 log10 CFU/g
Standard Deviation 0.39
|
7.95 log10 CFU/g
Standard Deviation 0.31
|
|
Modification of the Composition of the Intestinal Microflora: Clostridium Perfringens
Week 3
|
7.53 log10 CFU/g
Standard Deviation 0.69
|
7.78 log10 CFU/g
Standard Deviation 0.37
|
|
Modification of the Composition of the Intestinal Microflora: Clostridium Perfringens
Week 4
|
7.29 log10 CFU/g
Standard Deviation 0.52
|
7.54 log10 CFU/g
Standard Deviation 0.43
|
|
Modification of the Composition of the Intestinal Microflora: Clostridium Perfringens
Week 5
|
6.00 log10 CFU/g
Standard Deviation 0.72
|
6.83 log10 CFU/g
Standard Deviation 0.74
|
|
Modification of the Composition of the Intestinal Microflora: Clostridium Perfringens
Week 6
|
6.57 log10 CFU/g
Standard Deviation 0.37
|
6.65 log10 CFU/g
Standard Deviation 0.63
|
SECONDARY outcome
Timeframe: at week 0, 1, 2, 3, 4, 5, 6Fecal specimens were obtained from all 24 healthy volunteers at week 0, 1, 2, 3, 4, 5, 6. Bacterial colonies were cultured and counted.
Outcome measures
Outcome data not reported
Adverse Events
Fermented Milk (Study Group)
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Unfermented Milk (Placebo 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.Yi-Hsien Lin
Cheng Hsin Rehabilitation Medical Center
Phone: +886-2-28264400
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place