Fermented Milk Drink on Human Intestinal Microflora

Study Overview
=================
Brief 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.

Official Title
-----------------
Effects of a Fermented Milk Drink Containing Lactobacillus Casei Strain Shirota on the Human Intestinal Microflora

Conditions
-----------------
Signs and Symptoms, Digestive

Intervention / Treatment
-----------------
* Dietary Supplement: Yakult®300
* Dietary Supplement: Lactobacillus casei strain Shirota


Participation Criteria
=================
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

Ages Eligible for Study
-----------------
Minimum Age: 20 Years
Maximum Age: 65 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Basic Science
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br>Fermented milk with Lactobacillus casei strain Shirota 100ml per day | Dietary Supplement: Yakult®300<br>* Yakult®300 was given 100 ml once per day for four weeks. Fermented or unfermented milk per 100 ml bottle per day for four week.<br>Dietary Supplement: Lactobacillus casei strain Shirota<br>* Lactobacillus casei strain Shirota<br>|
| Placebo Comparator: 2<br>Unfermented milk without Lactobacillus casei strain Shirota 100ml per day | Dietary Supplement: Yakult®300<br>* Yakult®300 was given 100 ml once per day for four weeks. Fermented or unfermented milk per 100 ml bottle per day for four week.<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Modification of the Composition of the Intestinal Microflora: Bifidobacterium | 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. | week 0, 1, 2, 3, 4, 5, 6. | 
| Modification of the Composition of the Intestinal Microflora: Clostridium Perfringens | 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. | week 0, 1, 2, 3, 4, 5, 6. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Modification of the Composition of the Intestinal Microflora: Escherichia Coli, Lactobacillus Spp., Lactobacillus Casei Shirota | Fecal specimens were obtained from all 24 healthy volunteers at week 0, 1, 2, 3, 4, 5, 6. Bacterial colonies were cultured and counted. | at week 0, 1, 2, 3, 4, 5, 6 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Lactobacillus, Probiotics, Intestine, Flora