NCT01099696

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
302

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Apr 2010

Shorter than P25 for not_applicable

Geographic Reach
1 country

10 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2010

Completed
5 days until next milestone

First Submitted

Initial submission to the registry

April 6, 2010

Completed
1 day until next milestone

First Posted

Study publicly available on registry

April 7, 2010

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2010

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2010

Completed
Last Updated

December 20, 2012

Status Verified

December 1, 2012

Enrollment Period

6 months

First QC Date

April 6, 2010

Last Update Submit

December 19, 2012

Conditions

Abdominal DiscomfortBloating

Keywords

abdominal discomfort and bloating

Outcome Measures

Primary Outcomes (1)

  • The change in abdominal discomfort and bloating

    4 weeks

Study Arms (2)

B. infantis 35624

EXPERIMENTAL

B. infantis 35624 in white capsules

Dietary Supplement: B. infantis 35624

placebo

PLACEBO COMPARATOR

white placebo capsules (inert)

Dietary Supplement: placebo

Interventions

B. infantis 35624DIETARY_SUPPLEMENT

B. infantis 35624 in white capsules

B. infantis 35624
placeboDIETARY_SUPPLEMENT

white placebo capsules

placebo

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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;

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (10)

Research Site

Chicago, Illinois, 60610, United States

Location

Research Site

Rockford, Illinois, 61107, United States

Location

Research Site

Indianapolis, Indiana, 46240, United States

Location

Research Site

Chevy Chase, Maryland, 20815, United States

Location

Research Site

Chapel Hill, North Carolina, 27999, United States

Location

Research Site

Greensboro, North Carolina, 27403, United States

Location

Research Site

Cincinnati, Ohio, 45249, United States

Location

Research Site

Greer, South Carolina, 29651, United States

Location

Research Site

Nashville, Tennessee, 37205, United States

Location

Research Site

Charlottesville, Virginia, 22911, United States

Location

Related Publications (1)

  • 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.

    PMID: 27845337DERIVED

Study Officials

  • Jose Brum, MD

    P&G

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 6, 2010

First Posted

April 7, 2010

Study Start

April 1, 2010

Primary Completion

October 1, 2010

Study Completion

October 1, 2010

Last Updated

December 20, 2012

Record last verified: 2012-12

Locations

US(10)