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| Name | Class |
|---|---|
| Napo Pharmaceuticals, Inc. | INDUSTRY |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Crofelemer and Diagnostic tests for cause of chronic diarrhea | Experimental | 125 mg tablets taken by mouth twice daily for 28 days |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Crofelemer | Drug | 125 mg tablets taken by mouth twice daily for 28 days |
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| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With a 50 Percent Decrease in Mean Stool Count | Week 1 | |
| Number of Participants With a 50 Percent Decrease in Mean Stool Count | Week 2 | |
| Number of Participants With a 50 Percent Decrease in Mean Stool Count | Week 3 | |
| Number of Participants With a 50 Percent Decrease in Mean Stool Count | Week 4 |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With an Improvement in Stool Consistency by More Than 2 Levels as Measured by the Bristol Stool Form Scale | 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Brooks Cash, MD | The University of Texas Health Sciences Center at Houston | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The University of Texas Health Science Center at Houston | Houston | Texas | 77030 | United States |
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Of the 93 participants enrolled, 23 met the inclusion criteria and continued in the study to receive the intervention.
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| ID | Title | Description |
|---|---|---|
| FG000 | Crofelemer and Diagnostic Tests for Cause of Chronic Diarrhea | 125 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. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Dec 6, 2023 |
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| Diagnostic tests for cause of chronic diarrhea | Diagnostic Test | 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. |
|
| week 4 |
| Physical, Psychological, and Social Functioning as Measured by the Health-related Quality of Life (HRQOL) Questionnaire | 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. | Baseline,week 4 of treatment |
| Number of Participants With Any Abnormal Diagnostic Test Results Leading to the Identification of the Cause of Chronic Diarrhea | Baseline |
| Received Intervention |
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| COMPLETED |
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| NOT COMPLETED |
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includes all participants who received the intervention
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| ID | Title | Description |
|---|---|---|
| BG000 | Crofelemer and Diagnostic Tests for Cause of Chronic Diarrhea | 125 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. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants | Participants |
| ||||||||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||||||
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
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| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Number of Participants With a 50 Percent Decrease in Mean Stool Count | Posted | Count of Participants | Participants | Week 1 |
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| Secondary | Number of Participants With an Improvement in Stool Consistency by More Than 2 Levels as Measured by the Bristol Stool Form Scale | 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 | Posted | Count of Participants | Participants | week 4 |
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| ||||||||||||||||||||||||||||
| Secondary | Physical, Psychological, and Social Functioning as Measured by the Health-related Quality of Life (HRQOL) Questionnaire | 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. | Data were only collected from participants who completed the questionnaire. | Posted | Mean | Standard Deviation | score on a scale | Baseline,week 4 of treatment |
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| Secondary | Number of Participants With Any Abnormal Diagnostic Test Results Leading to the Identification of the Cause of Chronic Diarrhea | Data were not collected for 5 participants because required laboratory assessments were not performed. | Posted | Count of Participants | Participants | Baseline |
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| Primary | Number of Participants With a 50 Percent Decrease in Mean Stool Count | Posted | Count of Participants | Participants | Week 2 |
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| Primary | Number of Participants With a 50 Percent Decrease in Mean Stool Count | Posted | Count of Participants | Participants | Week 3 |
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| Primary | Number of Participants With a 50 Percent Decrease in Mean Stool Count | Posted | Count of Participants | Participants | Week 4 |
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4 Weeks
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Crofelemer and Diagnostic Tests for Cause of Chronic Diarrhea | 125 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 |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Brooks Cash, MD | The University of Texas Health Sciences Center at Houston | 713-500-6677 | Brooks.D.Cash@uth.tmc.edu |
| Jan 22, 2026 |
| Prot_SAP_000.pdf |
| ID | Term |
|---|---|
| D003967 | Diarrhea |
| D004194 | Disease |
| ID | Term |
|---|---|
| D012817 | Signs and Symptoms, Digestive |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D010335 | Pathologic Processes |
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| ID | Term |
|---|---|
| C546704 | crofelemer |
| D003955 | Diagnostic Tests, Routine |
| ID | Term |
|---|---|
| D019937 | Diagnostic Techniques and Procedures |
| D003933 | Diagnosis |
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| Unknown or Not Reported |
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| Native Hawaiian or Other Pacific Islander |
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| Black or African American |
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| White |
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| More than one race |
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| Unknown or Not Reported |
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| Participants |
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