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

Completed · Not applicable · Has a placebo group

Conditions studied: Abdominal Discomfort, Bloating

In brief

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

Key facts

Study ID: NCT01099696
Run by: Procter and Gamble
People needed: 302
Starts: 2010-04-01
Expected to finish: 2010-10-01
Last updated by the study team: 2012-12-20

Who can join

Age: 18 and older, up to 75. Sex: any. Healthy volunteers: accepted.

You may qualify if…

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.

You may not qualify if…

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;

Where it is running

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

Full record on ClinicalTrials.gov

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