NCT01428999

Brief Summary

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

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
48

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Sep 2011

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2011

Completed
1 day until next milestone

First Submitted

Initial submission to the registry

September 2, 2011

Completed
3 days until next milestone

First Posted

Study publicly available on registry

September 5, 2011

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2012

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2012

Completed
Last Updated

September 5, 2011

Status Verified

June 1, 2011

Enrollment Period

7 months

First QC Date

September 2, 2011

Last Update Submit

September 2, 2011

Conditions

Gastrointestinal FunctionIntestinal Bacteria Flora

Keywords

probioticsgastrointestinal functionintestinal bacteria flora

Outcome Measures

Primary Outcomes (1)

  • 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

Secondary Outcomes (1)

  • Changes of intestinal bacteria flora after probiotics use

    28 days

Study Arms (2)

probiotics

EXPERIMENTAL

1 pack bid use for 3 weeks

Dietary Supplement: probiotics

Placebo

PLACEBO COMPARATOR

placebo 1pack bid for 3 weeks

Dietary Supplement: probiotics

Interventions

probioticsDIETARY_SUPPLEMENT

probiotics 1 pack (2g) bid for three weeks

Placeboprobiotics

Eligibility Criteria

Age20 Years - 40 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Healthy people who are aged between 20 and 40 years

You may not qualify if:

  • \. 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

National Cheng Kung University Hospital

Tainan, Taiwan

Location

MeSH Terms

Interventions

Probiotics

Intervention Hierarchy (Ancestors)

Dietary SupplementsFoodDiet, Food, and NutritionPhysiological PhenomenaFood and Beverages

Study Officials

  • Ming-Cheng Wang, MD

    National Cheng-Kung University Hospital

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Ming-Cheng Wang, MD

CONTACT

886-6-2353535wangmc@mail.ncku.edu.tw

An-bang Wu, MD

CONTACT

886-6-2353535anbang@mail.ncku.edu.tw

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 2, 2011

First Posted

September 5, 2011

Study Start

September 1, 2011

Primary Completion

April 1, 2012

Study Completion

April 1, 2012

Last Updated

September 5, 2011

Record last verified: 2011-06

Locations

TW(1)