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 @ 11:38 PM
Ignite Modification Date:
2025-12-24 @ 11:38 PM
NCT ID:
NCT03898856
Eligibility Criteria:
Inclusion Criteria:
* Patients with chronic diarrhea (defined as 3 non-bloody loose stools per day or more than 20 non-bloody loose stools per week for more ≥ 4 weeks) and Bristol Stool Form Scale for stool consistency of 6/7 with \>50% stool without an obvious cause after evaluation for organic etiologies.
* Patients from any ethnicity
Exclusion Criteria:
* Hematochezia (potentially related to an organic cause).
* Subjects less than 18 years of age more than 75 years of age (safety and effectiveness of crofelemer has not been established in these age groups).
* Pregnant females (crofelemer is a Category C drug due to lack of well-controlled studies to study its effects in this population).
* Lactating females (it is unknown if crofelemer is excreted in the human milk and thus may have unknown adverse effects on the nursing infants).
* HIV positive individuals.
* Persons within ability to provide consent and understand the study
* Persons with history of alcohol abuse or binge drinking.
* Persons with history of surgical bowel resection or bariatric surgery in the past 12 months.
* Persons who have undergone cholecystectomy (open or laparoscopic) in the past 3 months.
* Persons receiving antibiotics currently or have received antimicrobials in the past 4 weeks.
* Persons with end-organ failures including end-stage renal disease, end-stage liver disease, or severe heart failure.
* Persons with metastatic hematologic and oncologic malignancies.
* Persons receiving chemo-radiation or immune-modulators for oncologic or rheumatologic conditions.
* Persons with any other known organic gastrointestinal or non-gastrointestinal disease process in which diarrhea is a recognized clinical feature.
* Gluten free diet for previous 3 months and refusal to ingest gluten.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
75 Years
Study:
NCT03898856
Study Brief:
Protocol Section:
NCT03898856