Irritable Bowel Syndrome Evaluation and Treatment in Primary Care

• Status: Completed
• Trial end date: 2012-03-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: American Academy of Family Physicians
• Collaborator: Genova Diagnostics
• Treatments: Nitazoxanide; Pancreatin; Pancrelipase

Criteria

Inclusion Criteria:

• between the ages of 18 and 65 years of age

• meet Rome III criteria for IBS

• willing to complete surveys and daily symptom logs for three to four 14-day periods

• have positive symptoms for at least 3 days out of the 14 days of the baseline daily log records

Exclusion Criteria:

• have HIV or AIDs

• have gall stones with a gall bladder present