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

The University of Texas System (UT)

Status and phase

Completed

Phase 4

Conditions

Chronic Diarrhea of Unknown Origin

Treatments

Diagnostic Test: Diagnostic tests for cause of chronic diarrhea

Drug: Crofelemer

Study type

Interventional

Funder types

Other

Industry

Identifiers

NCT03898856

HSC-MS-18-0990

Details and patient eligibility

About

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.

Enrollment

93 patients

Sex

All

Ages

18 to 75 years old

Volunteers

No 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.
Persons with end-organ failures including end-stage renal disease, end-stage liver disease, or severe heart failure.
Persons with metastatic hematologic and oncologic malignancies.
Persons receiving chemo-radiation or immune-modulators for oncologic or rheumatologic conditions.
Persons with any other known organic gastrointestinal or non-gastrointestinal disease process in which diarrhea is a recognized clinical feature.
Gluten free diet for previous 3 months and refusal to ingest gluten.