NCT03898856CompletedPhase 4
Yield of Diagnostic Tests and Effects of Crofelemer for Chronic Idiopathic Diarrhea In Non-HIV Patients
Yield of Diagnostic Tests and Management of Crofelemer for Chronic Idiopathic Diarrhea In Non-HIV Patients: A Pilot Study
Source: ClinicalTrials.gov · Last updated 12 Feb 2026
Brief summary (registry, in English)
The purpose of this study is to evaluate the effectiveness of the drug Crofelemer in the treatment of non-HIV patients with chronic idiopathic diarrhea; to determine the prevalence of identifiable causes of chronic diarrhea in a non-HIV patients; to assess the diagnostic yield, in terms of identification of treatable etiologies, of commercially available diagnostic evaluations in adult, non-HIV patients with chronic idiopathic diarrhea, that is, evaluate which tests, among the standard diagnostic tests commonly conducted as part of the evaluation of chronic idiopathic diarrhea, are most likely to identify a treatable cause of the diarrhea; and to analyze the relationship between chronic idiopathic diarrhea and health-related quality of life and assess the impact of crofelemer treatment on health-related quality of life.
- Status (registry)
- Completed
- Phase (registry)
- Phase 4
- Study type
- Interventional
- Enrollment
- 93 (actual)
- First submitted
- 29 Mar 2019
- Start date
- 1 Apr 2019
- Primary completion date
- 30 Jan 2025
- Lead sponsor
- The University of Texas Health Science Center, Houston
- NCT number
- NCT03898856
What you commit to
- Study type: Interventional · Phase 4
- Participants enrolled: 93
- From 1 Apr 2019 to the primary completion date, 30 Jan 2025
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Pregnant females (crofelemer is a Category C drug due to lack of well-controlled studies to study its effects in this population).
- Persons receiving antibiotics currently or have received antimicrobials in the past 4 weeks.
- Persons receiving chemo-radiation or immune-modulators for oncologic or rheumatologic conditions.
- Gluten free diet for previous 3 months and refusal to ingest gluten.
Other illness
- HIV positive individuals.
- 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 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 with any other known organic gastrointestinal or non-gastrointestinal disease process in which diarrhea is a recognized clinical feature.
Age
- 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).
Other
- Hematochezia (potentially related to an organic cause).
- Lactating females (it is unknown if crofelemer is excreted in the human milk and thus may have unknown adverse effects on the nursing infants).
- Persons within ability to provide consent and understand the study
- Persons who have undergone cholecystectomy (open or laparoscopic) in the past 3 months.
Who the study is looking for
- 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
Age in the registry: 18 years to 75 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| The University of Texas Health Science Center at Houston Coordinator of this site? Confirm its status | Houston | United States | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.