Chronic Diarrhea of Unknown Origin
Conditions
Keywords
diarrhea, diagnosis, crofelemer, 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.
Interventions
DRUGCrofelemer
125 mg tablets taken by mouth twice daily for 28 days
DIAGNOSTIC_TESTDiagnostic 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.
Sponsors
The University of Texas Health Science Center, Houston
Napo Pharmaceuticals, Inc.
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Number of Participants With a 50 Percent Decrease in Mean Stool Count | Week 1 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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 |
| Physical, Psychological, and Social Functioning as Measured by the Health-related Quality of Life (HRQOL) Questionnaire | 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 | Baseline | — |
Countries
United States
Contacts
PRINCIPAL_INVESTIGATORBrooks Cash, MD
The University of Texas Health Sciences Center at Houston
Participant flow
Pre-assignment details
Of the 93 participants enrolled, 23 met the inclusion criteria and continued in the study to receive the intervention.
Baseline characteristics
| Characteristic | — |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 7 Participants |
| Age, Categorical Between 18 and 65 years | 16 Participants |
| Ethnicity (NIH/OMB) Hispanic or Latino | 1 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 22 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 2 Participants |
| Race (NIH/OMB) Black or African American | 3 Participants |
| Race (NIH/OMB) More than one race | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) White | 18 Participants |
| Region of Enrollment United States | 23 participants |
| Sex: Female, Male Female | 17 Participants |
| Sex: Female, Male Male | 6 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 93 |
| other Total, other adverse events | 0 / 93 |
| serious Total, serious adverse events | 0 / 93 |
Outcome results
None listed