Effects of Probiotics on Improving the Gastrointestinal Function and Intestinal Bacterial Flora

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to evaluate the effect of combined probiotics to improve the gastrointestinal function and intestinal bacteria flora

Detailed Description
-----------------
Probiotics were known to improve gastrointestinal function before. This is a single-blind placebo control clinical study. We will perform gastrointestinal function questionnaire and collect stool as baseline data before the study (0-week). Then healthy subjects will be randomized to two groups. Experimental: probiotics 1 pack bid for 3 weeks. Probiotics : (AB-kefir)：Lactobacillus acidophilus,Bifidobacterium longum,Lactobacillus paracasei,Lactobacillus rhamnosus,Lactobacillus fermentum,Streptococcus thermophilus,Lactobacillus helveticus,Kluyveromyces fragilis. Other components include starch,oligosaccharide,yeast powder, superior standard spice， calcium pantothenate， VitB1， VitB12， biotin and folic acid. Placebo group: placebo 1 pack bid for 3 weeks. Placebo: Except the probiotics (AB-kefir),the other components are the same with study group. Then gastrointestinal function questionnaire and stool collection will be performed at the end of 1st, 2nd, 3rd, and 4th weeks after starting the study.

Official Title
-----------------
Effects of Probiotics on Improving the Gastrointestinal Function and Intestinal Bacterial Flora

Conditions
-----------------
Gastrointestinal Function, Intestinal Bacteria Flora

Intervention / Treatment
-----------------
* Dietary Supplement: probiotics


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Healthy people who are aged between 20 and 40 years Exclusion Criteria: 1. People who use probiotics medication and food that can inhibit bacteria growth within one month before the study 2. People who have active infection 3. People who have active or chronic gastro-intestinal disease 4. People who have diarrhea within two weeks before the study 5. People who are drug or alcohol abuser 6. People who are poor compliance

Ages Eligible for Study
-----------------
Minimum Age: 20 Years
Maximum Age: 40 Years

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

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

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

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: probiotics<br>1 pack bid use for 3 weeks | Dietary Supplement: probiotics<br>* probiotics 1 pack (2g) bid for three weeks<br>|
| Placebo Comparator: Placebo<br>placebo 1pack bid for 3 weeks | Dietary Supplement: probiotics<br>* probiotics 1 pack (2g) bid for three weeks<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Changes of gastrointestinal function after probiotics use | Changes of gastrointestinal function, such as constipation, abdominal distension and appetite after proiotics and placebo use. | 28 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Changes of intestinal bacteria flora after probiotics use | Changes of intestinal bacteria flora: (1) aerobic bacteria count (2) anaerobic bacteria count (3) Bifidobacterium count (4) Clostridium perfringens count (5) Staphylococcus aureus count (6) E. coli and K. pneumoniae count The ratio for the antibiotics resistant bacteria ( such as Vancomycin-resistant Enterococcus，third-generation cephalosporin resistance E. coli, Methicillin-resistant Staphylococcus aureous, Extended-spectrum beta lactamase E. coli and K. pneumoniae) Changes of the bacteria virulence factors for the intestinal E. coli and K. pneumonia | 28 days | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
probiotics, gastrointestinal function, intestinal bacteria flora