Study to Evaluate a Probiotic in Healthy Subjects With a History of Abdominal Discomfort and Bloating

December 19, 2012 updated by: Procter and Gamble

A Multicenter, Double-blind, Randomized, Placebo-controlled, Parallel-group Study to Evaluate the Benefit of a Probiotic (Bifidobacterium Infantis 35624) in Healthy Subjects With a History of Abdominal Discomfort and Bloating

This is a multicenter, double-blind, randomized, placebo-controlled, 6-week study of a probiotic for abdominal discomfort and bloating in healthy subjects.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

This is a multicenter, double-blind, randomized, placebo-controlled, parallel-group, 6-week study of a probiotic for abdominal discomfort and bloating in healthy subjects.

Study Type

Interventional

Enrollment (Actual)

302

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Illinois
      • Chicago, Illinois, United States, 60610
        • Research Site
      • Rockford,, Illinois, United States, 61107
        • Research Site
    • Indiana
      • Indianapolis, Indiana, United States, 46240
        • Research Site
    • Maryland
      • Chevy Chase, Maryland, United States, 20815
        • Research Site
    • North Carolina
      • Chapel Hill, North Carolina, United States, 27999
        • Research Site
      • Greensboro, North Carolina, United States, 27403
        • Research Site
    • Ohio
      • Cincinnati, Ohio, United States, 45249
        • Research Site
    • South Carolina
      • Greer, South Carolina, United States, 29651
        • Research Site
    • Tennessee
      • Nashville, Tennessee, United States, 37205
        • Research Site
    • Virginia
      • Charlottesville, Virginia, United States, 22911
        • Research Site

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • healthy men and non-pregnant, non-lactating women aged 18 to 75 years of age;
  • Body Mass Index (BMI) < or = 40;
  • if female, postmenopausal or using adequate contraception
  • if over 50 years of age, have had a colonoscopy performed in the previous 5 years with findings that are normal for this population
  • be willing to refrain from taking dietary supplements or other foods that contain fermented live bacteria during the study and be willing to refrain from taking any medications or preparations that treat lower digestive upsets
  • have experienced abdominal discomfort and bloating at least twice a week, on average, over the last 3 months.

Exclusion Criteria:

  • have been under a physician's care for functional bowel disorders within the past year or have taken prescription medication for functional bowel disorders within the past year;
  • have alarm symptoms suggestive of an underlying disease;
  • have prior GI surgery (appendectomy and hernia repair are not excluded and cholecystectomy at least 3 years ago is not excluded);
  • have a significant acute or chronic coexisting illness or condition;
  • have used systemic steroidal agents within the last 30 days;
  • have used oral or systemic antibiotics within the last 30 days;
  • have used probiotics at least 3 times a week within the last 30 days;

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: B. infantis 35624
B. infantis 35624 in white capsules
Dietary supplement: B. infantis 35624
B. infantis 35624 in white capsules
Placebo Comparator: placebo
white placebo capsules (inert)
Dietary supplement: placebo
white placebo capsules

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
The change in abdominal discomfort and bloating
Time Frame: 4 weeks
4 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Procter and Gamble

Investigators

  • Study Director: Jose Brum, MD, P&G

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2010

Primary Completion (Actual)

October 1, 2010

Study Completion (Actual)

October 1, 2010

Study Registration Dates

First Submitted

April 6, 2010

First Submitted That Met QC Criteria

April 6, 2010

First Posted (Estimate)

April 7, 2010

Study Record Updates

Last Update Posted (Estimate)

December 20, 2012

Last Update Submitted That Met QC Criteria

December 19, 2012

Last Verified

December 1, 2012

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • 2009120

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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