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

Not Applicable

• Conditions: Gastrointestinal Function; Intestinal Bacteria Flora

• Registration Number: NCT01428999
• Lead Sponsor: National Cheng-Kung University Hospital

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.

Study Timeline

• Status Verified: 2011-06
• Study Start: 2011-09
• Study First Submitted: 2011-09-02
• Study First Submitted QC: 2011-09-02
• Last Update Submitted: 2011-09-02
• Study First Posted: 2011-09-05
• Last Update Posted: 2011-09-05
• Primary Completion: 2012-04
• Study Completion: 2012-04

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 48

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Changes of gastrointestinal function after probiotics use	28 days	Changes of gastrointestinal function, such as constipation, abdominal distension and appetite after proiotics and placebo use.

Secondary Outcome Measures

Name	Time	Method
Changes of intestinal bacteria flora after probiotics use	28 days	1. 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; 2. 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); 3. Changes of the bacteria virulence factors for the intestinal E. coli and K. pneumonia

Trial Locations

Locations (1)

National Cheng Kung University Hospital; 🇨🇳 Tainan, Taiwan