Print

Purpose

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.

Condition

Eligibility

Eligible Ages
Between 18 Years and 75 Years
Eligible Genders
All
Accepts Healthy Volunteers
No

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 Design

Phase
Phase 4
Study Type
Interventional
Allocation
N/A
Intervention Model
Single Group Assignment
Primary Purpose
Treatment
Masking
None (Open Label)

Arm Groups

ArmDescriptionAssigned Intervention
Experimental
Crofelemer and Diagnostic tests for cause of chronic diarrhea 		125 mg tablets taken by mouth twice daily for 28 days
  • Drug: Crofelemer
    125 mg tablets taken by mouth twice daily for 28 days
  • Diagnostic Test: Diagnostic tests for cause of chronic diarrhea
    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.

Recruiting Locations

The University of Texas Health Science Center at Houston
Houston, Texas 77030
Contact:
Brooks Cash, MD

More Details

Status
Recruiting
Sponsor
The University of Texas Health Science Center, Houston

Study Contact

Brooks Cash, MD
713-500-6677
Brooks.D.Cash@uth.tmc.edu

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.