Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 7:32 PM
Ignite Modification Date:
2025-12-24 @ 7:32 PM
NCT ID:
NCT04612803
Eligibility Criteria:
Inclusion Criteria:
* Age 18 years and older
* Prior to Diagnosis of IBS + diarrhea based on ICD 10 codes with or without constipation unresponsive to prior treatments
* Moderate to severe symptom severity score (\>175 points) based on IBS symptom severity scale
* Seeking evaluation by a health care professional
* Negative serologic celiac panel
* No response to lactose elimination diet by history
* Normal colonoscopy
* Able to complete symptoms diaries and global evaluations
Exclusion Criteria:
* Confirmed IgE dependent food allergy as a cause of the gastrointestinal symptoms.
* Lactose intolerance by history
* Celiac disease by serology
* Inflammatory bowel disease or colitis
* Bile acid diarrhea by history
* Post-surgical GI symptoms (e.g., dumping syndrome) by history
* No colonoscopy performed
* GI malabsorption
* Current pregnancy
* Current severe depression or history of psychosis
* Current treatment with tricyclic antidepressants
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT04612803
Study Brief:
Protocol Section:
NCT04612803