Yield of Diagnostic Tests and Effects of Crofelemer for Chronic Idiopathic Diarrhea in Non-HIV Patients
- Conditions
- Chronic Diarrhea of Unknown Origin
- Interventions
- Diagnostic Test: Diagnostic tests for cause of chronic diarrhea
- Registration Number
- NCT03898856
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 93
- 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
- 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
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Crofelemer and Diagnostic tests for cause of chronic diarrhea Crofelemer 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 125 mg tablets taken by mouth twice daily for 28 days
- Primary Outcome Measures
Name Time Method Number of participants with a 50 percent decrease in mean stool count per week Week 4
- Secondary Outcome Measures
Name Time Method Change in participant diary descriptors as measured by number of anti-diarrheal medication taken per 24-hr period Baseline,week 4 of treatment Change in participant diary descriptor of daily time of administration of crofelemer Baseline,week 4 of treatment Time
Change in participant diary descriptors as measured by the presence of urgency with each bowel movement Baseline,week 4 of treatment 0-4 visual analog scale (0=none; 4=incontinence)
Change in participant diary descriptors as measured by supportive anti-diarrheal medication taken Baseline,week 4 of treatment Yes or no
Change in participant diary descriptors as measured by dose of supportive anti-diarrheal medication taken Baseline,week 4 of treatment Number of participants with an improvement in stool consistency by more than 2 levels as measured by the Bristol stool form scale 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
Change in physical, psychological, and social functioning as measured by the Health-related quality of life (HRQOL) questionnaire Baseline,week 4 of treatment The Medical Outcomes Trust short form questionnaire with 36 questions, most often referred to as SF-36, is a measure of general health status relevant across age, disease and treatment groups, widely used and tested in a range of conditions and settings. The items in SF-36 are divided into eight different domains with overall physical and mental health component summary scores. Domains are physical functioning, role limitations physical, bodily pain, social functioning, general mental health, role limitations emotional, vitality and general health. The SF-36 consists of eight scaled scores, which are the weighted sums of the questions in their section. Each scale is directly transformed into a 0-100 scale on the assumption that each question carries equal weight. The lower the score the more disability. The higher the score the less disability i.e., a score of zero is equivalent to maximum disability and a score of 100 is equivalent to no disability.
Number of participants with any abnormal diagnostic test results leading to the identification of the cause of chronic diarrhea Baseline Number of participants with abnormal diagnostic test results leading to the identification of the cause of chronic diarrhea-Esophagogastroduodenoscopy Baseline Number of participants with abnormal diagnostic test results leading to the identification of the cause of chronic diarrhea-Colonoscopy Baseline Number of participants with abnormal diagnostic test results leading to the identification of the cause of chronic diarrhea-Biopsy of duodenum Baseline Number of participants with abnormal diagnostic test results leading to the identification of the cause of chronic diarrhea-Biopsy of Colon Baseline Number of participants with abnormal diagnostic test results leading to the identification of the cause of chronic diarrhea-Prometheus IBcause Chronic Diarrhea panel Baseline Number of participants with abnormal diagnostic test results leading to the identification of the cause of chronic diarrhea-Thyroid Function Tests Baseline Number of participants with abnormal diagnostic test results leading to the identification of the cause of chronic diarrhea-Stool osmolality Baseline Number of participants with abnormal diagnostic test results leading to the identification of the cause of chronic diarrhea-Stool Ova and Parasites Baseline Number of participants with abnormal diagnostic test results leading to the identification of the cause of chronic diarrhea-Stool Culture Baseline Number of participants with abnormal diagnostic test results leading to the identification of the cause of chronic diarrhea-Stool Qualitative Stool Fat Baseline Number of participants with abnormal diagnostic test results leading to the identification of the cause of chronic diarrhea-Stool Reducing Substances Baseline Number of participants with abnormal diagnostic test results leading to the identification of the cause of chronic diarrhea-Laxative Screening Baseline Number of participants with abnormal diagnostic test results leading to the identification of the cause of chronic diarrhea-Lactulose Hydrogen Breath Test Baseline Number of participants with abnormal diagnostic test results leading to the identification of the cause of chronic diarrhea-Gastrin Level Baseline Number of participants with abnormal diagnostic test results leading to the identification of the cause of chronic diarrhea-. Calcitonin Level Baseline Number of participants with abnormal diagnostic test results leading to the identification of the cause of chronic diarrhea-VIP Level Baseline Change in participant diary descriptors as measured by time of bowel movements per 24 hr period Baseline,week 4 of treatment Change in participant diary descriptors as measured by number of loose stools per 24 hr period Baseline,week 4 of treatment Change in participant diary descriptors as measured by consistency of each bowel movement as per the Bristol Stool Form Scale Baseline,week 4 of treatment 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
Change in participant diary descriptor of any new symptoms Baseline,week 4 of treatment
Trial Locations
- Locations (1)
The University of Texas Health Science Center at Houston
🇺🇸Houston, Texas, United States