Crofelemer for Chronic Diarrhea

Overseen By Brooks Cash, MD

Age: 18+

Sex: Any

Trial Phase: Phase 4

Sponsor: The University of Texas Health Science Center, Houston

Must not be taking: Antibiotics, Chemo-radiation, Immune-modulators, others

Disqualifiers: HIV, Pregnancy, Alcohol abuse, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: Unknown

Duration: 4 weeks

93 Participants Needed

Trial Summary

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.

Research Team

Brooks Cash, MD

Principal Investigator

The University of Texas Health Sciences Center at Houston

Eligibility Criteria

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

Patients from any ethnicity

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.

Exclusion Criteria

You have been on a gluten-free diet for the past 3 months and are unwilling to consume gluten.

You are a breastfeeding mother. We don't know if crofelemer can pass into breast milk and potentially harm your baby.

Persons within ability to provide consent and understand the study.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive Crofelemer 125 mg tablets taken by mouth twice daily for 28 days

4 weeks

Weekly visits (in-person or virtual)

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

Treatment Details

Interventions

• Crofelemer

Trial Overview The study aims to test the effectiveness of Crofelemer in treating chronic idiopathic diarrhea in non-HIV patients. It also seeks to identify which standard diagnostic tests are most useful for finding treatable causes of this condition and how treatment affects quality of life.

Participant Groups

Group I: Crofelemer and Diagnostic tests for cause of chronic diarrhea Experimental Treatment 2 Interventions

125 mg tablets taken by mouth twice daily for 28 days

Who Is Running the Clinical Trial?

The University of Texas Health Science Center, Houston

Lead Sponsor

Trials

974

Recruited

361,000+

Napo Pharmaceuticals, Inc.

Industry Sponsor

Trials

6

Recruited

470+