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

Bloating Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01099696
• Other study ID #: 2009120
• Status: Completed
• Phase: N/A
• First received: April 6, 2010
• Last updated: December 19, 2012
• Start date: April 2010
• Est. completion date: October 2010

Study information

• Verified date: December 2012
• Source: Procter and Gamble
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 302
• Est. completion date: October 2010
• Est. primary completion date: October 2010
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 75 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Abdominal Discomfort
• Bloating

Intervention

Dietary Supplement:
• B. infantis 35624
B. infantis 35624 in white capsules
• placebo
white placebo capsules

Locations

Country	Name	City	State
United States	Research Site	Chapel Hill	North Carolina
United States	Research Site	Charlottesville	Virginia
United States	Research Site	Chevy Chase	Maryland
United States	Research Site	Chicago	Illinois
United States	Research Site	Cincinnati	Ohio
United States	Research Site	Greensboro	North Carolina
United States	Research Site	Greer	South Carolina
United States	Research Site	Indianapolis	Indiana
United States	Research Site	Nashville	Tennessee
United States	Research Site	Rockford,	Illinois

Sponsors (1)

Lead Sponsor	Collaborator
Procter and Gamble

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The change in abdominal discomfort and bloating		4 weeks	No