DRUG
Crofelemer
125 mg tablets taken by mouth twice daily for 28 days
Status
Completed
Phase
Phase 4
Enrollment
93
Locations
1
Results
Posted
Publications
0
Study 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.
Interventions
DRUG
125 mg tablets taken by mouth twice daily for 28 days
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.
Timeline
First posted
Apr 2, 2019
Study start
Apr 1, 2019
Primary completion
Jan 30, 2025
Study completion
Jan 30, 2025
Results posted
Feb 12, 2026
Registry updated
Feb 12, 2026
Outcomes
Number of Participants With a 50 Percent Decrease in Mean Stool Count
Time frame · Week 1
Number of Participants With a 50 Percent Decrease in Mean Stool Count
Time frame · Week 2
Number of Participants With a 50 Percent Decrease in Mean Stool Count
Time frame · Week 3
Number of Participants With a 50 Percent Decrease in Mean Stool Count
Time frame · Week 4
Number of Participants With an Improvement in Stool Consistency by More Than 2 Levels as Measured by the Bristol Stool Form Scale
Time frame · week 4
The Bristol stool form scale is a validated 1-7 scale that correlates to stool form. Type 1 is pebble like stool, type 2 lumpy and hard, type 3 like a sausage with cracks on the surface type 4 like a sausage but smooth and soft, type 5 soft blobs with clear cut edges, type 6 fluffy pieces with ragged edges, mushy stool, type 7watery, no solid pieces Types 5-7 are consistent with diarrhea and for this study a movement to lower types is considered an improvement
Physical, Psychological, and Social Functioning as Measured by the Health-related Quality of Life (HRQOL) Questionnaire
Time frame · Baseline,week 4 of treatment
Health-related quality of life questionnaire assesses psychological, and social functioning. The total score ranges from 0 to 100 with higher scores indicate better quality of life.
Number of Participants With Any Abnormal Diagnostic Test Results Leading to the Identification of the Cause of Chronic Diarrhea
Time frame · Baseline
Eligibility
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.
Study locations
United States. Showing up to 24 locations stored in the fast local snapshot.
The University of Texas Health Science Center at Houston
Houston, Texas, United States
Publications
No PMID-linked publications were present in this registry snapshot.
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