Primary outcomeCount of participants· Week 1
Number of Participants With a 50 Percent Decrease in Mean Stool Count
| Group | Value (Participants) |
|---|---|
| Crofelemer and Diagnostic Tests for Cause of Chronic Diarrhea | 17 |
Trial · Interventional
CompletedPhase 4Results postedRegistry dataYield of Diagnostic Tests and Effects of Crofelemer for Chronic Idiopathic Diarrhea In Non-HIV Patients
NCTNCT03898856 (opens ClinicalTrials.gov in a new tab)Other idHSC-MS-18-0990
This trial does not test a peptide that PepBank tracks.
- Names Vasoactive intestinal peptide (VIP, aviptadil), does not test it. It appears in the description.
Overview
- Status
- Completed
- Phase
- Phase 4
- Enrollment
- 93 participants (actual)
- Sponsor
- The University of Texas Health Science Center, Houston · Other
- Design
- Allocation not applicable · Open label (no masking)
- Countries
1 country
United States
- Start
- 1 Apr 2019
- Primary completion
- 30 Jan 2025
- Completion
- 30 Jan 2025
- First posted
- 2 Apr 2019
- Last update posted
- 12 Feb 2026
- Conditions
- Chronic Diarrhea of Unknown Origin
Timeline
1 trial · 1 completed · 1 with posted results
- Completed
- Ongoing
- Not yet recruiting
- Stopped
- Estimated dates (est.)
- Results posted
2020202220242026
- Ph 4
Yield of Diagnostic Tests and Effects of Crofelemer for Chronic Idiopathic Diarrhea In Non-HIV Patients
NCT038988561 Apr 2019 to 30 Jan 2025
Registry summary
Text and fields below are the sponsor's entries at ClinicalTrials.gov, shown as posted.
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
- CrofelemerDrug
- Diagnostic tests for cause of chronic diarrheaDiagnostic test
Arms1
Experimental
Crofelemer and Diagnostic tests for cause of chronic diarrhea
125 mg tablets taken by mouth twice daily for 28 days
Primary outcomes4
Outcomes the sponsor listed as primary.
Number of Participants With a 50 Percent Decrease in Mean Stool Count
Time frame · Week 1
Number of Participants With a 50 Percent Decrease in Mean Stool Count
Time frame · Week 2
Number of Participants With a 50 Percent Decrease in Mean Stool Count
Time frame · Week 3
Number of Participants With a 50 Percent Decrease in Mean Stool Count
Time frame · Week 4
Secondary outcomes(3)
Number of Participants With an Improvement in Stool Consistency by More Than 2 Levels as Measured by the Bristol Stool Form Scale
Time frame · week 4
Registry description
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
Time frame · Baseline,week 4 of treatment
Registry description
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
Time frame · Baseline
Posted results
Values are shown as posted at ClinicalTrials.gov, with their units. PepBank has not converted, pooled or compared them.
Primary outcome results
Primary outcomeCount of participants· Week 2
Number of Participants With a 50 Percent Decrease in Mean Stool Count
| Group | Value (Participants) |
|---|---|
| Crofelemer and Diagnostic Tests for Cause of Chronic Diarrhea | 16 |
Primary outcomeCount of participants· Week 3
Number of Participants With a 50 Percent Decrease in Mean Stool Count
| Group | Value (Participants) |
|---|---|
| Crofelemer and Diagnostic Tests for Cause of Chronic Diarrhea | 18 |
Primary outcomeCount of participants· Week 4
Number of Participants With a 50 Percent Decrease in Mean Stool Count
| Group | Value (Participants) |
|---|---|
| Crofelemer and Diagnostic Tests for Cause of Chronic Diarrhea | 17 |
Secondary and other outcome results(3)
Secondary outcomeCount of participants· week 4
Number of Participants With an Improvement in Stool Consistency by More Than 2 Levels as Measured by the Bristol Stool Form Scale
| Group | Value (Participants) |
|---|---|
| Crofelemer and Diagnostic Tests for Cause of Chronic Diarrhea | 18 |
Secondary outcomeMean· Baseline,week 4 of treatment
Physical, Psychological, and Social Functioning as Measured by the Health-related Quality of Life (HRQOL) Questionnaire
| Group | Value (score on a scale) | Spread |
|---|---|---|
| Crofelemer and Diagnostic Tests for Cause of Chronic Diarrhea | 63.8 | 9.32 |
Secondary outcomeCount of participants· Baseline
Number of Participants With Any Abnormal Diagnostic Test Results Leading to the Identification of the Cause of Chronic Diarrhea
| Group | Value (Participants) |
|---|---|
| Crofelemer and Diagnostic Tests for Cause of Chronic Diarrhea | 12 |
Adverse events, as posted
| Group | Deaths | Serious events | Other events |
|---|---|---|---|
| Crofelemer and Diagnostic Tests for Cause of Chronic Diarrhea125 mg tablets taken by mouth twice daily for 28 days Crofelemer: 125 mg tablets taken by mouth twice daily for 28 days 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. | 0 / 93 | 0 / 93 | 0 / 93 |
Each cell reads participants affected / participants at risk, as the registry posted them.
Registry data comes from ClinicalTrials.gov. Study results come from studies, not from the registry. How PepBank works
Studies0
Studies that cite this trial.
No study cites this trial.
Eligibility
Who could join, as posted.
- Sex
- All
- Age
- from 18 Years up to 75 Years
- Healthy volunteers
- Not accepted
Inclusion and exclusion criteria, as posted
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.
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