Clinical trial NCT01099696: Study to Evaluate a Probiotic in Healthy Subjects With a History of Abdominal Discomfort and Bloating
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Abdominal Discomfort
Bloating
Keywords: abdominal discomfort and bloating
Lead sponsor: Procter and Gamble
Sponsor class: INDUSTRY
First posted: 2010-04-07
Enrollment: 302
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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: 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.

Eligibility criteria: 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;

Primary outcomes:
measure: The change in abdominal discomfort and bloating
timeFrame: 4 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Chicago
country: United States
facility: Research Site
state: Illinois
city: Rockford,
country: United States
facility: Research Site
state: Illinois
city: Indianapolis
country: United States
facility: Research Site
state: Indiana
city: Chevy Chase
country: United States
facility: Research Site
state: Maryland
city: Chapel Hill
country: United States
facility: Research Site
state: North Carolina
city: Greensboro
country: United States
facility: Research Site
state: North Carolina
city: Cincinnati
country: United States
facility: Research Site
state: Ohio
city: Greer
country: United States
facility: Research Site
state: South Carolina
city: Nashville
country: United States
facility: Research Site
state: Tennessee
city: Charlottesville
country: United States
facility: Research Site
state: Virginia
Study officials:
affiliation: P&G
name: Jose Brum, MD
role: STUDY_DIRECTOR
References:
citation: Ringel-Kulka T, McRorie J, Ringel Y. Multi-Center, Double-Blind, Randomized, Placebo-Controlled, Parallel-Group Study to Evaluate the Benefit of the Probiotic Bifidobacterium infantis 35624 in Non-Patients With Symptoms of Abdominal Discomfort and Bloating. Am J Gastroenterol. 2017 Jan;112(1):145-151. doi: 10.1038/ajg.2016.511. Epub 2016 Nov 15.