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

NCT03898856 | Completed Phase 4 Results FDA Drug

• 1 other identifier: HSC-MS-18-0990
• Study Type: interventional
• Target: 93
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Chronic Diarrhea of Unknown Origin

Keywords

diarrhea; diagnosis; crofelemer; treatment

Outcome Measures

Primary Outcomes (4)

• Number of Participants With a 50 Percent Decrease in Mean Stool Count

  Week 1

• Number of Participants With a 50 Percent Decrease in Mean Stool Count

  Week 2

• Number of Participants With a 50 Percent Decrease in Mean Stool Count

  Week 3

• Number of Participants With a 50 Percent Decrease in Mean Stool Count

  Week 4

Secondary Outcomes (3)

• Number of Participants With an Improvement in Stool Consistency by More Than 2 Levels as Measured by the Bristol Stool Form Scale

  week 4

• Physical, Psychological, and Social Functioning as Measured by the Health-related Quality of Life (HRQOL) Questionnaire

  Baseline,week 4 of treatment

• Number of Participants With Any Abnormal Diagnostic Test Results Leading to the Identification of the Cause of Chronic Diarrhea

  Baseline

Study Arms (1)

Crofelemer and Diagnostic tests for cause of chronic diarrhea

EXPERIMENTAL

125 mg tablets taken by mouth twice daily for 28 days

Drug: Crofelemer; Diagnostic Test: Diagnostic tests for cause of chronic diarrhea

Interventions

Crofelemer DRUG

125 mg tablets taken by mouth twice daily for 28 days

Crofelemer and Diagnostic tests for cause of chronic diarrhea

Diagnostic tests for cause of chronic diarrhea DIAGNOSTIC_TEST

Diagnostic tests include: Esophagogastroduodenoscopy, Colonoscopy, biopsies of the upper gastrointestinal tract (duodenum) and lower gastrointestinal tract (colon), genetic testing for Congenital sucrase-isomaltase deficiency (CSID),Prometheus IBcause Chronic Diarrhea panel, Thyroid Panel, Stool osmolality, Stool Ova and Parasites, Stool Culture, Stool Qualitative Stool Fat, Stool Reducing Substances, Laxative Screening, Lactulose Hydrogen Breath Test, Gastrin Level, Calcitonin Level, Vasoactive Intestinal Polypeptide(VIP) level.

Crofelemer and Diagnostic tests for cause of chronic diarrhea

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Napo Pharmaceuticals, Inc.: collaborator
• The University of Texas Health Science Center, Houston: lead

Study Sites (1)

The University of Texas Health Science Center at Houston

Houston, Texas, 77030, United States

Location

MeSH Terms

Conditions

Diarrhea; Disease

Interventions

crofelemer; Diagnostic Tests, Routine

Condition Hierarchy (Ancestors)

Signs and Symptoms, Digestive; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Pathologic Processes

Intervention Hierarchy (Ancestors)

Diagnostic Techniques and Procedures; Diagnosis

Results Point of Contact

• Title: Brooks Cash, MD
• Organization: The University of Texas Health Sciences Center at Houston

Brooks.D.Cash@uth.tmc.edu

713-500-6677

Study Officials

• Brooks Cash, MD

  The University of Texas Health Sciences Center at Houston

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Visiting professor

Study Record Dates

• First Submitted: March 29, 2019
• First Posted: April 2, 2019
• Study Start: April 1, 2019
• Primary Completion: January 30, 2025
• Study Completion: January 30, 2025
• Last Updated: February 12, 2026
• Results First Posted: February 12, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)