Irritable Bowel Syndrome Evaluation and Treatment in Primary Care
Public ClinicalTrials.gov record NCT01641341. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
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.
Study identification
- NCT ID
- NCT01641341
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Phase 4
- Enrollment
- 61 participants
Conditions and interventions
Conditions
Eligibility (public fields only)
- Age range
- 18 Years to 65 Years
- Sex
- All
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Oct 31, 2010
- Primary completion
- Feb 29, 2012
- Completion
- Feb 29, 2012
- Last update posted
- Jan 22, 2019
2010 – 2012
United States locations
- U.S. sites
- 9
- U.S. states
- 7
- U.S. cities
- 7
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Torrance Clinical Research | Lomita | California | 90717 | — |
| Overland Park Family Health Partners | Leawood | Kansas | 66209 | — |
| American Academy of Family Physicians-National Research Network | Leawood | Kansas | 66211 | — |
| Baton Rouge Family Practice | Baton Rouge | Louisiana | 70806 | — |
| Family Medicine of SE Missouri | Sikeston | Missouri | 63801 | — |
| Missouri Delta Physician Services | Sikeston | Missouri | 63801 | — |
| Silver Sage Center for Family Medicine | Reno | Nevada | 89521 | — |
| Raj Kachoria | Macedon | New York | 14502 | — |
| Southwest Family Medicine Associates | Dallas | Texas | 75235 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT01641341, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Jan 22, 2019 · Synced Sep 2, 2026
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Open the official record
The complete protocol, eligibility criteria, and contact information for NCT01641341 live on ClinicalTrials.gov.