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Yield of Diagnostic Tests and Effects of Crofelemer for Chronic Idiopathic Diarrhea In Non-HIV Patients

Primary Purpose

Chronic Diarrhea of Unknown Origin

Status
Recruiting
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
Crofelemer
Diagnostic tests for cause of chronic diarrhea
Sponsored by
The University of Texas Health Science Center, Houston
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Chronic Diarrhea of Unknown Origin focused on measuring diarrhea, diagnosis, crofelemer, treatment

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • The University of Texas Health Science Center at HoustonRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Crofelemer and Diagnostic tests for cause of chronic diarrhea

Arm Description

125 mg tablets taken by mouth twice daily for 28 days

Outcomes

Primary Outcome Measures

Number of participants with a 50 percent decrease in mean stool count per week

Secondary Outcome Measures

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
Change in physical, psychological, and social functioning as measured by the Health-related quality of life (HRQOL) questionnaire
The Medical Outcomes Trust short form questionnaire with 36 questions, most often referred to as SF-36, is a measure of general health status relevant across age, disease and treatment groups, widely used and tested in a range of conditions and settings. The items in SF-36 are divided into eight different domains with overall physical and mental health component summary scores. Domains are physical functioning, role limitations physical, bodily pain, social functioning, general mental health, role limitations emotional, vitality and general health. The SF-36 consists of eight scaled scores, which are the weighted sums of the questions in their section. Each scale is directly transformed into a 0-100 scale on the assumption that each question carries equal weight. The lower the score the more disability. The higher the score the less disability i.e., a score of zero is equivalent to maximum disability and a score of 100 is equivalent to no disability.
Number of participants with any abnormal diagnostic test results leading to the identification of the cause of chronic diarrhea
Number of participants with abnormal diagnostic test results leading to the identification of the cause of chronic diarrhea-Esophagogastroduodenoscopy
Number of participants with abnormal diagnostic test results leading to the identification of the cause of chronic diarrhea-Colonoscopy
Number of participants with abnormal diagnostic test results leading to the identification of the cause of chronic diarrhea-Biopsy of duodenum
Number of participants with abnormal diagnostic test results leading to the identification of the cause of chronic diarrhea-Biopsy of Colon
Number of participants with abnormal diagnostic test results leading to the identification of the cause of chronic diarrhea-Prometheus IBcause Chronic Diarrhea panel
Number of participants with abnormal diagnostic test results leading to the identification of the cause of chronic diarrhea-Thyroid Function Tests
Number of participants with abnormal diagnostic test results leading to the identification of the cause of chronic diarrhea-Stool osmolality
Number of participants with abnormal diagnostic test results leading to the identification of the cause of chronic diarrhea-Stool Ova and Parasites
Number of participants with abnormal diagnostic test results leading to the identification of the cause of chronic diarrhea-Stool Culture
Number of participants with abnormal diagnostic test results leading to the identification of the cause of chronic diarrhea-Stool Qualitative Stool Fat
Number of participants with abnormal diagnostic test results leading to the identification of the cause of chronic diarrhea-Stool Reducing Substances
Number of participants with abnormal diagnostic test results leading to the identification of the cause of chronic diarrhea-Laxative Screening
Number of participants with abnormal diagnostic test results leading to the identification of the cause of chronic diarrhea-Lactulose Hydrogen Breath Test
Number of participants with abnormal diagnostic test results leading to the identification of the cause of chronic diarrhea-Gastrin Level
Number of participants with abnormal diagnostic test results leading to the identification of the cause of chronic diarrhea-. Calcitonin Level
Number of participants with abnormal diagnostic test results leading to the identification of the cause of chronic diarrhea-VIP Level
Change in participant diary descriptors as measured by time of bowel movements per 24 hr period
Change in participant diary descriptors as measured by number of loose stools per 24 hr period
Change in participant diary descriptors as measured by consistency of each bowel movement as per 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
Change in participant diary descriptors as measured by the presence of urgency with each bowel movement
0-4 visual analog scale (0=none; 4=incontinence)
Change in participant diary descriptors as measured by supportive anti-diarrheal medication taken
Yes or no
Change in participant diary descriptors as measured by dose of supportive anti-diarrheal medication taken
Change in participant diary descriptors as measured by number of anti-diarrheal medication taken per 24-hr period
Change in participant diary descriptor of daily time of administration of crofelemer
Time
Change in participant diary descriptor of any new symptoms

Full Information

First Posted
March 29, 2019
Last Updated
May 15, 2023
Sponsor
The University of Texas Health Science Center, Houston
Collaborators
Napo Pharmaceuticals, Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT03898856
Brief Title
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

2. Study Status

Record Verification Date
May 2023
Overall Recruitment Status
Recruiting
Study Start Date
April 1, 2019 (Actual)
Primary Completion Date
December 31, 2023 (Anticipated)
Study Completion Date
December 31, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
The University of Texas Health Science Center, Houston
Collaborators
Napo Pharmaceuticals, Inc.

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Diarrhea of Unknown Origin
Keywords
diarrhea, diagnosis, crofelemer, treatment

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
100 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Crofelemer and Diagnostic tests for cause of chronic diarrhea
Arm Type
Experimental
Arm Description
125 mg tablets taken by mouth twice daily for 28 days
Intervention Type
Drug
Intervention Name(s)
Crofelemer
Intervention Description
125 mg tablets taken by mouth twice daily for 28 days
Intervention Type
Diagnostic Test
Intervention Name(s)
Diagnostic tests for cause of chronic diarrhea
Intervention Description
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.
Primary Outcome Measure Information:
Title
Number of participants with a 50 percent decrease in mean stool count per week
Time Frame
Week 4
Secondary Outcome Measure Information:
Title
Number of participants with an improvement in stool consistency by more than 2 levels as measured by the Bristol stool form scale
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
Time Frame
week 4
Title
Change in physical, psychological, and social functioning as measured by the Health-related quality of life (HRQOL) questionnaire
Description
The Medical Outcomes Trust short form questionnaire with 36 questions, most often referred to as SF-36, is a measure of general health status relevant across age, disease and treatment groups, widely used and tested in a range of conditions and settings. The items in SF-36 are divided into eight different domains with overall physical and mental health component summary scores. Domains are physical functioning, role limitations physical, bodily pain, social functioning, general mental health, role limitations emotional, vitality and general health. The SF-36 consists of eight scaled scores, which are the weighted sums of the questions in their section. Each scale is directly transformed into a 0-100 scale on the assumption that each question carries equal weight. The lower the score the more disability. The higher the score the less disability i.e., a score of zero is equivalent to maximum disability and a score of 100 is equivalent to no disability.
Time Frame
Baseline,week 4 of treatment
Title
Number of participants with any abnormal diagnostic test results leading to the identification of the cause of chronic diarrhea
Time Frame
Baseline
Title
Number of participants with abnormal diagnostic test results leading to the identification of the cause of chronic diarrhea-Esophagogastroduodenoscopy
Time Frame
Baseline
Title
Number of participants with abnormal diagnostic test results leading to the identification of the cause of chronic diarrhea-Colonoscopy
Time Frame
Baseline
Title
Number of participants with abnormal diagnostic test results leading to the identification of the cause of chronic diarrhea-Biopsy of duodenum
Time Frame
Baseline
Title
Number of participants with abnormal diagnostic test results leading to the identification of the cause of chronic diarrhea-Biopsy of Colon
Time Frame
Baseline
Title
Number of participants with abnormal diagnostic test results leading to the identification of the cause of chronic diarrhea-Prometheus IBcause Chronic Diarrhea panel
Time Frame
Baseline
Title
Number of participants with abnormal diagnostic test results leading to the identification of the cause of chronic diarrhea-Thyroid Function Tests
Time Frame
Baseline
Title
Number of participants with abnormal diagnostic test results leading to the identification of the cause of chronic diarrhea-Stool osmolality
Time Frame
Baseline
Title
Number of participants with abnormal diagnostic test results leading to the identification of the cause of chronic diarrhea-Stool Ova and Parasites
Time Frame
Baseline
Title
Number of participants with abnormal diagnostic test results leading to the identification of the cause of chronic diarrhea-Stool Culture
Time Frame
Baseline
Title
Number of participants with abnormal diagnostic test results leading to the identification of the cause of chronic diarrhea-Stool Qualitative Stool Fat
Time Frame
Baseline
Title
Number of participants with abnormal diagnostic test results leading to the identification of the cause of chronic diarrhea-Stool Reducing Substances
Time Frame
Baseline
Title
Number of participants with abnormal diagnostic test results leading to the identification of the cause of chronic diarrhea-Laxative Screening
Time Frame
Baseline
Title
Number of participants with abnormal diagnostic test results leading to the identification of the cause of chronic diarrhea-Lactulose Hydrogen Breath Test
Time Frame
Baseline
Title
Number of participants with abnormal diagnostic test results leading to the identification of the cause of chronic diarrhea-Gastrin Level
Time Frame
Baseline
Title
Number of participants with abnormal diagnostic test results leading to the identification of the cause of chronic diarrhea-. Calcitonin Level
Time Frame
Baseline
Title
Number of participants with abnormal diagnostic test results leading to the identification of the cause of chronic diarrhea-VIP Level
Time Frame
Baseline
Title
Change in participant diary descriptors as measured by time of bowel movements per 24 hr period
Time Frame
Baseline,week 4 of treatment
Title
Change in participant diary descriptors as measured by number of loose stools per 24 hr period
Time Frame
Baseline,week 4 of treatment
Title
Change in participant diary descriptors as measured by consistency of each bowel movement as per the Bristol Stool Form Scale
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
Time Frame
Baseline,week 4 of treatment
Title
Change in participant diary descriptors as measured by the presence of urgency with each bowel movement
Description
0-4 visual analog scale (0=none; 4=incontinence)
Time Frame
Baseline,week 4 of treatment
Title
Change in participant diary descriptors as measured by supportive anti-diarrheal medication taken
Description
Yes or no
Time Frame
Baseline,week 4 of treatment
Title
Change in participant diary descriptors as measured by dose of supportive anti-diarrheal medication taken
Time Frame
Baseline,week 4 of treatment
Title
Change in participant diary descriptors as measured by number of anti-diarrheal medication taken per 24-hr period
Time Frame
Baseline,week 4 of treatment
Title
Change in participant diary descriptor of daily time of administration of crofelemer
Description
Time
Time Frame
Baseline,week 4 of treatment
Title
Change in participant diary descriptor of any new symptoms
Time Frame
Baseline,week 4 of treatment

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Brooks Cash, MD
Phone
713-500-6677
Email
Brooks.D.Cash@uth.tmc.edu
First Name & Middle Initial & Last Name or Official Title & Degree
Brooks Cash, MD
Email
gi.research@uth.tmc.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Brooks Cash, MD
Organizational Affiliation
The University of Texas Health Sciences Center at Houston
Official's Role
Principal Investigator
Facility Information:
Facility Name
The University of Texas Health Science Center at Houston
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Brooks Cash, MD

12. IPD Sharing Statement

Plan to Share IPD
No

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Yield of Diagnostic Tests and Effects of Crofelemer for Chronic Idiopathic Diarrhea In Non-HIV Patients

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