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

Procter & Gamble (P&G)

Status

Completed

Conditions

Bloating

Abdominal Discomfort

Treatments

Dietary Supplement: B. infantis 35624

Dietary Supplement: placebo

Study type

Interventional

Funder types

Industry

Identifiers

NCT01099696

2009120

Details and patient eligibility

About

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

Full 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.

Enrollment

302 patients

Sex

All

Ages

18 to 75 years old

Volunteers

Accepts Healthy Volunteers

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;