Phase 2
N=24
Fermented Milk Drink on Human Intestinal Microflora
Signs and Symptoms, Digestive
Bottom Line
View on ClinicalTrials.gov: NCT00822328 ↗Enrolled (actual)
24
Serious AEs
—
Results posted
Aug 2009
Primary outcome: Primary: Modification of the Composition of the Intestinal Microflora: Bifidobacterium — 7.88; 7.60; 8.13; 8.10 log10 CFU/g — p=<0.05
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- Yakult®300 (Dietary_supplement); Lactobacillus casei strain Shirota (Dietary_supplement)
- Age
- Adult, Older Adult · 20+ yrs
- Sex
- All
- Sponsor
- Cheng Hsin Rehabilitation Medical Center
- Primary completion
- Mar 2009
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Modification of the Composition of the Intestinal Microflora: Bifidobacterium |
7.88; 7.60; 8.13; 8.10; 9.03; 8.35 | <0.05 sig |
| PRIMARY Modification of the Composition of the Intestinal Microflora: Clostridium Perfringens |
7.13; 7.24; 7.61; 7.57; 8.04; 7.95 | <0.05 sig |
| SECONDARY Modification of the Composition of the Intestinal Microflora: Escherichia Coli, Lactobacillus Spp., Lactobacillus Casei Shirota |
— | — |
Summary
Fermented milk is a popular drink. Recent studies revealed that some fermented milk containing some strains of lactic acid bacteria have health-promoting effects through improvement of the intestinal microflora and modulation of the immune system. Lactobacillus casei strain Shirota (LcS) is a probiotic bacterium used in the production of fermented milk products and lactic acid bacteria preparations. LcS has been shown to modify allergen-induced immune responses in allergic rhinitis, altering fermentation patterns in the small bowel, prevention of recurrent urinary tract infections in women. Yakult®300 is a fermented milk containing at least 3x10^10 live LcS cells per 100 ml bottle. This study aimed to evaluate the effects of a fermented milk drink containing Lactobacillus casei strain Shirota on the human intestinal microflora.
Eligibility Criteria
Inclusion Criteria
- Healthy adult volunteers and willing to give voluntary written informed consent
Exclusion Criteria
- Major systemic disease
- Pregnancy, parturient and feeding woman, or expect to be pregnant
- Abnormal liver function
- Abnormal renal function
- Abnormal gastrointestinal function
- Take medication for gastrointestinal function
- Stroke, myocardial infarction,
- Poor compliance for study protocol
Data sourced from ClinicalTrials.gov (NCT00822328). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.