- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01428999
Effects of Probiotics on Improving the Gastrointestinal Function and Intestinal Bacterial Flora
Study Overview
Status
Intervention / Treatment
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 Type
Enrollment (Anticipated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Ming-Cheng Wang, MD
- Phone Number: 2594 886-6-2353535
- Email: wangmc@mail.ncku.edu.tw
Study Locations
-
-
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Tainan, Taiwan
- National Cheng Kung University Hospital
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Contact:
- Ming-Cheng Wang, MD
- Phone Number: 2594 886-6-2353535
- Email: wangmc@mail.ncku.edu.tw
-
Principal Investigator:
- Ming-Cheng Wang, MD
-
Sub-Investigator:
- An-Bang Wu, MD
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Sub-Investigator:
- Hung-Lien Wu
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Sub-Investigator:
- Jiunn-Jong Wu, PhD
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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 Plan
How is the study designed?
Design Details
- Primary Purpose: TREATMENT
- Allocation: RANDOMIZED
- Interventional Model: PARALLEL
- Masking: SINGLE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
EXPERIMENTAL: probiotics
1 pack bid use for 3 weeks
|
probiotics 1 pack (2g) bid for three weeks
|
PLACEBO_COMPARATOR: Placebo
placebo 1pack bid for 3 weeks
|
probiotics 1 pack (2g) bid for three weeks
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Changes of gastrointestinal function after probiotics use
Time Frame: 28 days
|
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
Time Frame: 28 days
|
|
28 days
|
Collaborators and Investigators
Collaborators
Investigators
- Principal Investigator: Ming-Cheng Wang, MD, National Cheng-Kung University Hospital
Study record dates
Study Major Dates
Study Start
Primary Completion (ANTICIPATED)
Study Completion (ANTICIPATED)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ESTIMATE)
Study Record Updates
Last Update Posted (ESTIMATE)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- BR-100-039
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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