New hope for unexplained chronic diarrhea: drug trial shows promise
NCT ID NCT03898856
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This study tested the drug crofelemer in 93 adults with chronic diarrhea of unknown cause (not related to HIV). The goal was to see if the drug reduces stool frequency and improves consistency, and to find out which diagnostic tests are most useful. Results may help doctors better manage this challenging condition.
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Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 4
Runs after approval, following long-term safety and how well the treatment works in everyday use.
- Participants
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93 people
The number who actually took part.
- Started
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Apr 2019
- Finished
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Jan 2025
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 to 75 years
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
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.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
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The University of Texas Health Science Center at Houston
Houston, Texas, 77030, United States