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

NCT ID: NCT01428999

Last Updated: 2011-09-05

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

48 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-09-30

Study Completion Date

2012-04-30

Brief Summary

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

Detailed Description

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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.

Conditions

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Gastrointestinal Function Intestinal Bacteria Flora

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants

Study Groups

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probiotics

1 pack bid use for 3 weeks

Group Type EXPERIMENTAL

probiotics

Intervention Type DIETARY_SUPPLEMENT

probiotics 1 pack (2g) bid for three weeks

Placebo

placebo 1pack bid for 3 weeks

Group Type PLACEBO_COMPARATOR

probiotics

Intervention Type DIETARY_SUPPLEMENT

probiotics 1 pack (2g) bid for three weeks

Interventions

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probiotics

probiotics 1 pack (2g) bid for three weeks

Intervention Type DIETARY_SUPPLEMENT

Eligibility Criteria

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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
Minimum Eligible Age

20 Years

Maximum Eligible Age

40 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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National Science and Technology Council, Taiwan

OTHER_GOV

Sponsor Role collaborator

National Cheng-Kung University Hospital

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Ming-Cheng Wang, MD

Role: PRINCIPAL_INVESTIGATOR

National Cheng-Kung University Hospital

Locations

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National Cheng Kung University Hospital

Tainan City, , Taiwan

Site Status

Countries

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Taiwan

Central Contacts

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Ming-Cheng Wang, MD

Role: CONTACT

886-6-2353535 ext. 2594

An-bang Wu, MD

Role: CONTACT

886-6-2353535 ext. 2594

Facility Contacts

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Ming-Cheng Wang, MD

Role: primary

886-6-2353535 ext. 2594

An-Bang Wu, MD

Role: backup

886-6-2353535 ext. 2594

Other Identifiers

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BR-100-039

Identifier Type: -

Identifier Source: org_study_id

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