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

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01099696

Enrollment

302

Registered

2010-04-07

Start date

2010-04-30

Completion date

2010-10-31

Last updated

2012-12-20

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Abdominal Discomfort, Bloating

Keywords

abdominal discomfort and bloating

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.

Interventions

DIETARY_SUPPLEMENTB. infantis 35624

B. infantis 35624 in white capsules

DIETARY_SUPPLEMENTplacebo

white placebo capsules

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

TRIPLE (Subject, Caregiver, Investigator)

Eligibility

Sex/Gender

ALL

Age

18 Years to 75 Years

Healthy volunteers

Yes

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;

Design outcomes

Primary

Measure	Time frame
The change in abdominal discomfort and bloating	4 weeks

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026