Irritable Bowel Syndrome Evaluation and Treatment in Primary Care
Status:
Completed
Trial end date:
2012-03-01
Target enrollment:
Participant gender:
Summary
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.