Clinical trial NCT03898856: Yield of Diagnostic Tests and Effects of Crofelemer for Chronic Idiopathic Diarrhea in Non-HIV Patients
Official title: Yield of Diagnostic Tests and Management of Crofelemer for Chronic Idiopathic Diarrhea in Non-HIV Patients: a Pilot Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Chronic Diarrhea of Unknown Origin
Keywords: diarrhea
diagnosis
crofelemer
treatment
Lead sponsor: The University of Texas Health Science Center, Houston
Sponsor class: OTHER
Collaborators: name: Napo Pharmaceuticals, Inc.
First posted: 2019-04-02
Enrollment: 93
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.


Eligibility criteria: 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.

Primary outcomes:
measure: Number of participants with a 50 percent decrease in mean stool count per week
timeFrame: Week 4
Secondary outcomes:
measure: Number of participants with an improvement in stool consistency by more than 2 levels as measured by the Bristol stool form scale
timeFrame: week 4
measure: Change in physical, psychological, and social functioning as measured by the Health-related quality of life (HRQOL) questionnaire
timeFrame: Baseline,week 4 of treatment
measure: Number of participants with any abnormal diagnostic test results leading to the identification of the cause of chronic diarrhea
timeFrame: Baseline
measure: Number of participants with abnormal diagnostic test results leading to the identification of the cause of chronic diarrhea-Esophagogastroduodenoscopy
timeFrame: Baseline
measure: Number of participants with abnormal diagnostic test results leading to the identification of the cause of chronic diarrhea-Colonoscopy
timeFrame: Baseline
measure: Number of participants with abnormal diagnostic test results leading to the identification of the cause of chronic diarrhea-Biopsy of duodenum
timeFrame: Baseline
measure: Number of participants with abnormal diagnostic test results leading to the identification of the cause of chronic diarrhea-Biopsy of Colon
timeFrame: Baseline
measure: Number of participants with abnormal diagnostic test results leading to the identification of the cause of chronic diarrhea-Prometheus IBcause Chronic Diarrhea panel
timeFrame: Baseline
measure: Number of participants with abnormal diagnostic test results leading to the identification of the cause of chronic diarrhea-Thyroid Function Tests
timeFrame: Baseline
measure: Number of participants with abnormal diagnostic test results leading to the identification of the cause of chronic diarrhea-Stool osmolality
timeFrame: Baseline
measure: Number of participants with abnormal diagnostic test results leading to the identification of the cause of chronic diarrhea-Stool Ova and Parasites
timeFrame: Baseline
measure: Number of participants with abnormal diagnostic test results leading to the identification of the cause of chronic diarrhea-Stool Culture
timeFrame: Baseline
measure: Number of participants with abnormal diagnostic test results leading to the identification of the cause of chronic diarrhea-Stool Qualitative Stool Fat
timeFrame: Baseline
measure: Number of participants with abnormal diagnostic test results leading to the identification of the cause of chronic diarrhea-Stool Reducing Substances
timeFrame: Baseline
measure: Number of participants with abnormal diagnostic test results leading to the identification of the cause of chronic diarrhea-Laxative Screening
timeFrame: Baseline
measure: Number of participants with abnormal diagnostic test results leading to the identification of the cause of chronic diarrhea-Lactulose Hydrogen Breath Test
timeFrame: Baseline
measure: Number of participants with abnormal diagnostic test results leading to the identification of the cause of chronic diarrhea-Gastrin Level
timeFrame: Baseline
measure: Number of participants with abnormal diagnostic test results leading to the identification of the cause of chronic diarrhea-. Calcitonin Level
timeFrame: Baseline
measure: Number of participants with abnormal diagnostic test results leading to the identification of the cause of chronic diarrhea-VIP Level
timeFrame: Baseline
measure: Change in participant diary descriptors as measured by time of bowel movements per 24 hr period
timeFrame: Baseline,week 4 of treatment
measure: Change in participant diary descriptors as measured by number of loose stools per 24 hr period
timeFrame: Baseline,week 4 of treatment
measure: Change in participant diary descriptors as measured by consistency of each bowel movement as per the Bristol Stool Form Scale
timeFrame: Baseline,week 4 of treatment
measure: Change in participant diary descriptors as measured by the presence of urgency with each bowel movement
timeFrame: Baseline,week 4 of treatment
measure: Change in participant diary descriptors as measured by supportive anti-diarrheal medication taken
timeFrame: Baseline,week 4 of treatment
measure: Change in participant diary descriptors as measured by dose of supportive anti-diarrheal medication taken
timeFrame: Baseline,week 4 of treatment
measure: Change in participant diary descriptors as measured by number of anti-diarrheal medication taken per 24-hr period
timeFrame: Baseline,week 4 of treatment
measure: Change in participant diary descriptor of daily time of administration of crofelemer
timeFrame: Baseline,week 4 of treatment
measure: Change in participant diary descriptor of any new symptoms
timeFrame: Baseline,week 4 of treatment
Other outcomes:
Locations:
city: Houston
country: United States
facility: The University of Texas Health Science Center at Houston
state: Texas
Study officials:
affiliation: The University of Texas Health Sciences Center at Houston
name: Brooks Cash, MD
role: PRINCIPAL_INVESTIGATOR
References: