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NCT Number: NCT03898856

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

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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Key information

Conditions

Chronic Diarrhea of Unknown Origin Diarrhea Disease Pathologic Processes Pathological Conditions, Signs and Symptoms Signs and Symptoms Signs and Symptoms, Digestive

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

The University of Texas Health Science Center at Houston

Houston, Texas, 77030, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Crofelemer

Drug

125 mg tablets taken by mouth twice daily for 28 days

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.

Primary outcomes

  1. Number of Participants With a 50 Percent Decrease in Mean Stool Count

    Time frame: Week 1

  2. Number of Participants With a 50 Percent Decrease in Mean Stool Count

    Time frame: Week 2

  3. Number of Participants With a 50 Percent Decrease in Mean Stool Count

    Time frame: Week 3

  4. Number of Participants With a 50 Percent Decrease in Mean Stool Count

    Time frame: Week 4

Secondary outcomes

  1. 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

    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

  2. Physical, Psychological, and Social Functioning as Measured by the Health-related Quality of Life (HRQOL) Questionnaire

    Time frame: 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.

  3. Number of Participants With Any Abnormal Diagnostic Test Results Leading to the Identification of the Cause of Chronic Diarrhea

    Time frame: Baseline

Sponsors and collaborators

Lead sponsor

The University of Texas Health Science Center, Houston

Other

Collaborators

  • Napo Pharmaceuticals, Inc.

Registry information

Official study title

Yield of Diagnostic Tests and Management of Crofelemer for Chronic Idiopathic Diarrhea In Non-HIV Patients: A Pilot Study

Important dates

Study start
2019
Primary completion
2025
Study completion
2025
First posted
Apr 2, 2019
Registry last updated
Feb 12, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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