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Yield of Diagnostic Tests and Effects of Crofelemer for Chronic Idiopathic Diarrhea In Non-HIV Patients | Clinical Trials | Clareo Health

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Yield of Diagnostic Tests and Effects of Crofelemer for Chronic Idiopathic Diarrhea In Non-HIV Patients

Yield of Diagnostic Tests and Management of Crofelemer for Chronic Idiopathic Diarrhea In Non-HIV Patients: A Pilot Study

NCT03898856•The University of Texas Health Science Center, Houston

View on ClinicalTrials.gov

Summary

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.

Eligibility

Age

18 - 75 years

Sex

ALL

Healthy Volunteers

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.
+5 more criteria

Locations (1)

The University of Texas Health Science Center at Houston

Houston, Texas, United States

Key Dates

Start Date

April 1, 2019

Primary Completion Date

January 30, 2025

Completion Date

January 30, 2025

Last Updated

February 12, 2026

Enrollment

ACTUAL participants

Conditions

Chronic Diarrhea of Unknown Origin

Interventions

Crofelemer

DRUG

Diagnostic tests for cause of chronic diarrhea

DIAGNOSTIC_TEST