Crofelemer for Chronic Diarrhea
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial tests the effectiveness of Crofelemer for individuals with chronic diarrhea not caused by HIV. Researchers aim to identify other treatable causes of the diarrhea and assess how the drug impacts daily life quality. Participants will take Crofelemer pills twice daily for 28 days. Those experiencing chronic diarrhea, defined as at least three loose, non-bloody stools per day for four weeks or more, may qualify for this study. As a Phase 4 trial, Crofelemer has already received FDA approval and proven effective, offering participants the opportunity to benefit from a well-established treatment.
Will I have to stop taking my current medications?
The trial does not specify if you need to stop taking your current medications, but you cannot participate if you are currently taking antibiotics or have taken them in the past 4 weeks. It's best to discuss your specific medications with the trial team.
What is the safety track record for this treatment?
Research has shown that crofelemer is as safe as a placebo, an inactive pill, across different patient groups. In studies with HIV-positive patients, crofelemer was well-tolerated, with side effects similar to those of a placebo. Another study found that individuals using crofelemer for diarrhea experienced side effects mostly like those seen with a placebo. Overall, the treatment appears safe for humans, with generally mild side effects similar to not taking any active medication.12345
Why are researchers enthusiastic about this study treatment?
Crofelemer is unique because it targets chloride channels in the intestines to reduce fluid secretion, which can effectively manage chronic diarrhea. Unlike many standard treatments that primarily address symptoms or infections, Crofelemer’s mechanism of action directly addresses the underlying cause of fluid imbalance, offering a novel approach. Researchers are excited about Crofelemer because it is derived from a natural source, the Croton lechleri plant, and it has shown potential to offer relief with fewer side effects compared to conventional options like loperamide or bismuth subsalicylate.
What is the effectiveness track record for Crofelemer in treating chronic diarrhea?
Research has shown that crofelemer, the treatment under study in this trial, can reduce symptoms of long-lasting diarrhea. In earlier studies, it firmed stools and reduced stomach pain without causing constipation. Initially, it successfully treated diarrhea in people with HIV/AIDS. Crofelemer also managed diarrhea caused by the cancer drug neratinib, nearly doubling the likelihood of symptom improvement. These findings suggest that crofelemer could be a helpful treatment for people with chronic diarrhea not related to HIV.14678
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