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

Gastrointestinal Function Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT01428999
• Other study ID #: BR-100-039
• Status: Not yet recruiting
• Phase: N/A
• First received: September 2, 2011
• Last updated: September 2, 2011
• Start date: September 2011
• Est. completion date: April 2012

Study information

• Verified date: June 2011
• Source: National Cheng-Kung University Hospital
• Contact: Ming-Cheng Wang, MD
• Phone: 886-6-2353535
• Email: wangmc[@]mail.ncku.edu.tw
• Is FDA regulated: No
• Health authority: Taiwan: Institutional Review Board
• Study type: Interventional

Clinical Trial Summary

The purpose of this study is to evaluate the effect of "combined probiotics" to improve the gastrointestinal function and intestinal bacteria flora

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 48
• Est. completion date: April 2012
• Est. primary completion date: April 2012
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 20 Years to 40 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Gastrointestinal Function
• Intestinal Bacteria Flora

Intervention

Dietary Supplement:
• probiotics
probiotics 1 pack (2g) bid for three weeks

Locations

Country	Name	City	State
Taiwan	National Cheng Kung University Hospital	Tainan

Sponsors (2)

Lead Sponsor	Collaborator
National Cheng-Kung University Hospital	National Science Council, Taiwan

Country where clinical trial is conducted

Taiwan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	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	No