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

Not Applicable

Completed

• Conditions: Abdominal Discomfort; Bloating
• Interventions: Dietary Supplement: placebo; Dietary Supplement: B. infantis 35624

• Registration Number: NCT01099696
• Lead Sponsor: Procter and Gamble

Brief Summary

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

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 Timeline

• Study Start: 2010-04
• Study First Submitted: 2010-04-06
• Study First Submitted QC: 2010-04-06
• Study First Posted: 2010-04-07
• Primary Completion: 2010-10
• Study Completion: 2010-10
• Status Verified: 2012-12
• Last Update Submitted: 2012-12-19
• Last Update Posted: 2012-12-20

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 302

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
placebo	placebo	white placebo capsules (inert)
B. infantis 35624	B. infantis 35624	B. infantis 35624 in white capsules

Primary Outcome Measures

Name	Time	Method
The change in abdominal discomfort and bloating	4 weeks

Trial Locations

Locations (1)

Research Site; 🇺🇸 Charlottesville, Virginia, United States