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

NCT ID: NCT01099696

Last Updated: 2012-12-20

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

COMPLETED

Clinical Phase

NA

Total Enrollment

302 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-04-30

Study Completion Date

2010-10-31

Brief Summary

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

Detailed Description

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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.

Conditions

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Abdominal Discomfort Bloating

Keywords

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abdominal discomfort and bloating

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Caregivers Investigators

Study Groups

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B. infantis 35624

B. infantis 35624 in white capsules

Group Type EXPERIMENTAL

B. infantis 35624

Intervention Type DIETARY_SUPPLEMENT

B. infantis 35624 in white capsules

placebo

white placebo capsules (inert)

Group Type PLACEBO_COMPARATOR

placebo

Intervention Type DIETARY_SUPPLEMENT

white placebo capsules

Interventions

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B. infantis 35624

B. infantis 35624 in white capsules

Intervention Type DIETARY_SUPPLEMENT

placebo

white placebo capsules

Intervention Type DIETARY_SUPPLEMENT

Eligibility Criteria

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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;
Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Procter and Gamble

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Jose Brum, MD

Role: STUDY_DIRECTOR

P&G

Locations

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Research Site

Chicago, Illinois, United States

Site Status

Research Site

Rockford, Illinois, United States

Site Status

Research Site

Indianapolis, Indiana, United States

Site Status

Research Site

Chevy Chase, Maryland, United States

Site Status

Research Site

Chapel Hill, North Carolina, United States

Site Status

Research Site

Greensboro, North Carolina, United States

Site Status

Research Site

Cincinnati, Ohio, United States

Site Status

Research Site

Greer, South Carolina, United States

Site Status

Research Site

Nashville, Tennessee, United States

Site Status

Research Site

Charlottesville, Virginia, United States

Site Status

Countries

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United States

References

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Ringel-Kulka T, McRorie J, Ringel Y. Multi-Center, Double-Blind, Randomized, Placebo-Controlled, Parallel-Group Study to Evaluate the Benefit of the Probiotic Bifidobacterium infantis 35624 in Non-Patients With Symptoms of Abdominal Discomfort and Bloating. Am J Gastroenterol. 2017 Jan;112(1):145-151. doi: 10.1038/ajg.2016.511. Epub 2016 Nov 15.

Reference Type DERIVED
PMID: 27845337 (View on PubMed)

Other Identifiers

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2009120

Identifier Type: -

Identifier Source: org_study_id