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Clinical trialNCT01641341CompletedPhase 4Interventional

Irritable Bowel Syndrome Evaluation and Treatment in Primary Care

SponsorAmerican Academy of Family PhysiciansEnrollment61Irritable Bowel Syndrome
View the registry record on ClinicalTrials.gov

Summary

The lay summary the sponsor registered on ClinicalTrials.gov.

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.

Investigators

The overall officials registered on this study. Names that resolve to a FindMyKOL profile link to it; the rest are shown as registered.

A profile link is shown only when the registered name resolves to a person record with a confident, namesake-checked match; ambiguous names stay unlinked.

Sites

9 registered facilities, with the per-site recruitment status where the registry publishes one. ClinicalTrials.gov does not publish per-site enrollment counts.

United States
  • Torrance Clinical Research

    Lomita, California, United States

  • American Academy of Family Physicians-National Research Network

    Leawood, Kansas, United States

  • Overland Park Family Health Partners

    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

Site investigator names are published by ClinicalTrials.gov only while a study recruits, so completed studies list sites without them.

Drugs studied

The drug and biological interventions registered on this study, normalized to their RxNorm ingredient where possible.

Linked drugs open the directory filtered to KOLs working with them.clinicaltrials.gov ↗

Registration & key dates

Registry attributes as recorded on the ClinicalTrials.gov study record.

Start
30 Nov 2010
Primary completion
31 Mar 2012
Completion
31 Mar 2012
Last update posted
23 Jan 2019
Registered enrollment
61
Registry id
NCT01641341

Source: ClinicalTrials.gov, via the CTTI AACT database, data as of 11 Nov 2026. Registry facts are shown as registered by the study sponsor; FindMyKOL does not interpret them.