Yield of Diagnostic Tests and Effects of Crofelemer for Chronic Idiopathic Diarrhea In Non-HIV Pa… (NCT03898856) | Clinical Trial Compass
CompletedPhase 4
Yield of Diagnostic Tests and Effects of Crofelemer for Chronic Idiopathic Diarrhea In Non-HIV Patients
United States93 participantsStarted 2019-04-01
Plain-language 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.
Who can participate
Age range
18 Years – 75 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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-radi…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Number of Participants With a 50 Percent Decrease in Mean Stool Count
Timeframe: Week 1
2
Number of Participants With a 50 Percent Decrease in Mean Stool Count
Timeframe: Week 2
3
Number of Participants With a 50 Percent Decrease in Mean Stool Count
Timeframe: Week 3
4
Number of Participants With a 50 Percent Decrease in Mean Stool Count
Timeframe: Week 4
Trial details
NCT IDNCT03898856
SponsorThe University of Texas Health Science Center, Houston