Who is sponsoring NCT01641341?

NCT01641341 is sponsored by American Academy of Family Physicians.

What condition does NCT01641341 study?

NCT01641341 studies Irritable Bowel Syndrome.

What drugs are being tested in NCT01641341?

Interventions: Bifidobacterium infantis, Pancrelipase, Nitazoxanide, Placebo.

What is the status of NCT01641341?

NCT01641341 is currently COMPLETED.

Last reviewed 2019-01-18 · How we verify

Irritable Bowel Syndrome Evaluation and Treatment in Primary Care

NCT01641341 Phase 4 COMPLETED

Overview of Methods: This is a double blind, randomized controlled trial with a non-balanced randomization and a cross-over to active treatment for placebo treated individuals who do not respond to the placebo treatment. Data collected will help determine the feasibility of the study design in primary care offices. Patient outcome data will provide a more precise estimate of power for a larger, classic randomized trial to determine if such a study can be reasonably undertaken within primary care practices. Aims: The aims of this pilot study are to: 1) Evaluate how well Genova Diagnostics (GDx) IBS tests can be integrated into primary care, 2) examine the effects of the Genova Diagnostics (GDx) test on treatment, and 3) observe and track patients' health, quality of life and clinical outcomes related to IBS during the study period.

Details

Lead sponsor	American Academy of Family Physicians
Phase	Phase 4
Status	COMPLETED
Enrolment	61
Start date	2010-11
Completion	2012-03

Conditions

Irritable Bowel Syndrome

Interventions

Bifidobacterium infantis
Pancrelipase
Nitazoxanide
Placebo

Primary outcomes

A reduction in IBS symptoms — 16 weeks
20 to 40% of the control/placebo patients and approximately 70-75% of the treatment patients will experience a positive outcome as determined by both the daily log sheets and the modified Rome criteria administered at baseline, 8 and 16 weeks.

Countries

United States