Irritable Bowel Syndrome Evaluation and Treatment in Primary Care

Completed · Phase 4 · Has a placebo group

Conditions studied: Irritable Bowel Syndrome

In brief

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.

Key facts

Study ID

NCT01641341

Run by

American Academy of Family Physicians

People needed

61

Starts

2010-11-01

Expected to finish

2012-03-01

Last updated by the study team

2019-01-23

Who can join

Age: 18 and older, up to 65. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• have HIV or AIDs
• have gall stones with a gall bladder present

Where it is running

• Torrance Clinical Research — Lomita, California, United States
• Overland Park Family Health Partners — Leawood, Kansas, United States
• American Academy of Family Physicians-National Research Network — Leawood, Kansas, United States
• Baton Rouge Family Practice — Baton Rouge, Louisiana, United States
• Family Medicine of SE Missouri — Sikeston, Missouri, United States
• Missouri Delta Physician Services — Sikeston, Missouri, United States
• Silver Sage Center for Family Medicine — Reno, Nevada, United States
• Raj Kachoria — Macedon, New York, United States
• Southwest Family Medicine Associates — Dallas, Texas, United States

Full record on ClinicalTrials.gov

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