NCT04486326

Crofelemer for Functional Diarrhea

• Status: Terminated
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 17 (actual)
• Sponsor: Beth Israel Deaconess Medical Center · Academic / Other
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

Summary

The primary objectives of this study are to evaluate the clinical response of patients with diarrhea to crofelemer relative to placebo and evaluate the overall safety and tolerability of crofelemer in the treatment of diarrhea.

Detailed description

Crofelemer is a potent antisecretory agent and has promising therapeutic properties for functional diarrhea patients. Crofelemer is an active compound extracted from the latex of the Western South American plant Croton lechleri. The latex has been used for medicinal purposes for centuries by indigenous peoples, with its active properties attributable to the crofelemer compound (11). Crofelemer has an inhibitory effect on cyclic AMP-mediated secretion of chloride ions in T84 and Caco-2 epithelial cells, resulting in antisecretory effects in the colon that may alleviate diarrhea and related symptoms (12). Crofelemer has been shown to improve traveler's diarrhea and HIV-associated diarrhea (13,14). It's applicability to symptoms of functional diarrhea is still unclear. In a Phase II randomized trial, Mangel \& Chaturvedi observed the effects of crofelemer in the setting of Inflammatory Bowel Syndrome-D (15). While they did not meet the primary endpoint of altering stool consistency in IBS-D patients, they did find upon further analysis that crofelemer significantly reduced the number of pain- and discomfort-free days in female patients with IBS-D. This study warrants further investigation of the effects of crofelemer in treating symptoms of functional diarrhea.

Conditions

• Diarrhea

Interventions

Type	Name	Description
DRUG	Crofelemer	Crofelemer
DRUG	Placebo	placebo

Timeline

• Start date: 2020-08-20
• Primary completion: 2022-09-23
• Completion: 2022-09-23
• First posted: 2020-07-24
• Last updated: 2026-03-10
• Results posted: 2026-03-10

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study