Crofelemer for Chronic Diarrhea
What You Need to Know Before You Apply
What is the purpose of this trial?
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.
Who Is on the Research Team?
Brooks Cash, MD
Principal Investigator
The University of Texas Health Sciences Center at Houston
Are You a Good Fit for This Trial?
This trial is for non-HIV patients with chronic diarrhea, defined as having frequent loose stools without an obvious cause despite prior tests. Participants should be adults not on a gluten-free diet, not pregnant or lactating, and without a history of significant alcohol use, bowel surgeries, recent antibiotic use, or serious organ failure.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive Crofelemer 125 mg tablets taken by mouth twice daily for 28 days
Follow-up
Participants are monitored for safety and effectiveness after treatment
What Are the Treatments Tested in This Trial?
Interventions
- Crofelemer
Find a Clinic Near You
Who Is Running the Clinical Trial?
The University of Texas Health Science Center, Houston
Lead Sponsor
Napo Pharmaceuticals, Inc.
Industry Sponsor