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

Study Overview
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Brief Summary
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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
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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.

Official Title
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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

Conditions
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Abdominal Discomfort, Bloating

Intervention / Treatment
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* Dietary Supplement: B. infantis 35624
* Dietary Supplement: placebo


Participation Criteria
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Eligibility Criteria
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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;

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: B. infantis 35624<br>B. infantis 35624 in white capsules | Dietary Supplement: B. infantis 35624<br>* B. infantis 35624 in white capsules<br>|
| Placebo Comparator: placebo<br>white placebo capsules (inert) | Dietary Supplement: placebo<br>* white placebo capsules<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The change in abdominal discomfort and bloating |  | 4 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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abdominal discomfort and bloating