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

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

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

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.

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;