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

This study is not yet open for participant recruitment.
Verified June 2011 by National Cheng-Kung University Hospital
Sponsor:
Collaborator:
National Science Council, Taiwan
Information provided by (Responsible Party):
National Cheng-Kung University Hospital
ClinicalTrials.gov Identifier:
NCT01428999
First received: September 2, 2011
Last updated: NA
Last verified: June 2011
History: No changes posted
  Purpose

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


Condition Intervention
Gastrointestinal Function
Intestinal Bacteria Flora
 Dietary Supplement: probiotics

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Primary Purpose: Treatment
Official Title: Effects of Probiotics on Improving the Gastrointestinal Function and Intestinal Bacterial Flora

Further study details as provided by National Cheng-Kung University Hospital:

Primary Outcome Measures:
  • Changes of gastrointestinal function after probiotics use [ Time Frame: 28 days ] [ Designated as safety issue: No ]
    Changes of gastrointestinal function, such as constipation, abdominal distension and appetite after proiotics and placebo use.


Secondary Outcome Measures:
  • Changes of intestinal bacteria flora after probiotics use [ Time Frame: 28 days ] [ Designated as safety issue: No ]
    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


Estimated Enrollment: 48
Study Start Date: September 2011
Estimated Study Completion Date: April 2012
Estimated Primary Completion Date: April 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: probiotics
1 pack bid use for 3 weeks
 Dietary Supplement: probiotics
probiotics 1 pack (2g) bid for three weeks
Placebo Comparator: Placebo
placebo 1pack bid for 3 weeks
 Dietary Supplement: probiotics
probiotics 1 pack (2g) bid for three weeks

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.

  Eligibility

Ages Eligible for Study:   20 Years to 40 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01428999

Contacts
Contact: Ming-Cheng Wang, MD 886-6-2353535 ext 2594 wangmc@mail.ncku.edu.tw
Contact: An-bang Wu, MD 886-6-2353535 ext 2594 anbang@mail.ncku.edu.tw

Locations
Taiwan
National Cheng Kung University Hospital Recruiting
Tainan, Taiwan
Contact: Ming-Cheng Wang, MD     886-6-2353535 ext 2594     wangmc@mail.ncku.edu.tw    
Contact: An-Bang Wu, MD     886-6-2353535 ext 2594     anbang@mail.ncku.edu.tw    
Principal Investigator: Ming-Cheng Wang, MD            
Sub-Investigator: An-Bang Wu, MD            
Sub-Investigator: Hung-Lien Wu            
Sub-Investigator: Jiunn-Jong Wu, PhD            
Sponsors and Collaborators
National Cheng-Kung University Hospital
National Science Council, Taiwan
Investigators
Principal Investigator: Ming-Cheng Wang, MD National Cheng-Kung University Hospital
  More Information

No publications provided

Responsible Party: National Cheng-Kung University Hospital
ClinicalTrials.gov Identifier: NCT01428999     History of Changes
Other Study ID Numbers: BR-100-039
Study First Received: September 2, 2011
Last Updated: September 2, 2011
Health Authority: Taiwan: Institutional Review Board

Keywords provided by National Cheng-Kung University Hospital:
probiotics
gastrointestinal function
intestinal bacteria flora

ClinicalTrials.gov processed this record on May 23, 2013