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Anti-Diarrheal Agent

Crofelemer for Chronic Diarrhea

Phase 4
Recruiting
Led By Brooks Cash, MD
Research Sponsored by The University of Texas Health Science Center, Houston
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline,week 4 of treatment
Awards & highlights

Study Summary

This trial is studying how well Crofelemer works in treating patients with non-HIV related chronic idiopathic diarrhea. They will also be looking at how common it is for an identifiable cause of chronic diarrhea to be found in non-HIV patients, and how effective different diagnostic tests are in identifying a treatable cause of chronic idiopathic diarrhea. Finally, they will be assessing the impact of Crofelemer treatment on health-related quality of life.

Who is the study for?
This trial is for non-HIV patients with chronic diarrhea, defined as having frequent loose stools without an obvious cause despite prior tests. Participants should be adults not on a gluten-free diet, not pregnant or lactating, and without a history of significant alcohol use, bowel surgeries, recent antibiotic use, or serious organ failure.Check my eligibility
What is being tested?
The study aims to test the effectiveness of Crofelemer in treating chronic idiopathic diarrhea in non-HIV patients. It also seeks to identify which standard diagnostic tests are most useful for finding treatable causes of this condition and how treatment affects quality of life.See study design
What are the potential side effects?
While specific side effects for Crofelemer in this context aren't listed here, common ones may include digestive system discomfort such as bloating or gas, headache, coughing or respiratory issues.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline
This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Number of participants with a 50 percent decrease in mean stool count per week
Secondary outcome measures
Change in participant diary descriptor of any new symptoms
Change in participant diary descriptor of daily time of administration of crofelemer
Change in participant diary descriptors as measured by consistency of each bowel movement as per the Bristol Stool Form Scale
+25 more

Trial Design

1Treatment groups
Experimental Treatment
Group I: Crofelemer and Diagnostic tests for cause of chronic diarrheaExperimental Treatment2 Interventions
125 mg tablets taken by mouth twice daily for 28 days
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Crofelemer
2017
Completed Phase 3
~310

Find a Location

Who is running the clinical trial?

The University of Texas Health Science Center, HoustonLead Sponsor
904 Previous Clinical Trials
320,897 Total Patients Enrolled
Napo Pharmaceuticals, Inc.Industry Sponsor
4 Previous Clinical Trials
332 Total Patients Enrolled
Brooks Cash, MD4.579 ReviewsPrincipal Investigator - The University of Texas Health Sciences Center at Houston
El Camino Hospital Mountain View
Medical School - Creighton University, Doctor of Medicine
University of Chicago, Residency in Surgery
1 Previous Clinical Trials
320 Total Patients Enrolled
5Patient Review
This physician was very thorough and considerate. I felt like they really took the time to listen to me and explain things. I would highly recommend them.

Media Library

Chronic Diarrhea Clinical Trial 2023: Crofelemer Highlights & Side Effects. Trial Name: NCT03898856 — Phase 4
Crofelemer (Anti-Diarrheal Agent) 2023 Treatment Timeline for Medical Study. Trial Name: NCT03898856 — Phase 4

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Do individuals aged 50+ qualify for participation in the research trial?

"This clinical trial is open to all people aged 18-75. For those who don't meet the age criteria, there are 28 trials for minors and 48 trials specifically designed for senior citizens."

Answered by AI

Are there any open vacancies for enrolment in this experiment?

"Affirmative. According to clinicaltrials.gov, recruiting for this medical trial is currently underway; the study was first posted on April 1st 2019 and recently updated on April 26th 2022. Approximately 100 patients will be accepted from a solitary site."

Answered by AI

What other empirical studies have investigated the utility of diagnostic tests for determining the source of persistent diarrhea?

"At the moment, two distinct clinical trials on Diagnostic tests for cause of chronic diarrhea are active with one trial in its final phase. While most locations running these trials are situated near Lafayette, Colorado, there is an additional 15 across the US conducting similar research."

Answered by AI

What are the FDA-sanctioned diagnostic tools for determining the source of chronic diarrhea?

"Diagnostic tests for the cause of chronic diarrhoea has earned a safety rating of 3 due to its status as an approved treatment in Phase 4 trials."

Answered by AI

What is the maximum number of participants for this trial?

"Affirmative. Clinicaltrials.gov data suggests that this medical investigation, which was initially published on April 1st 2019, is actively scouting for participants. Approximately 100 individuals must be recruited from a single clinical centre."

Answered by AI

Is this the initial attempt at a clinical trial of its kind?

"Research into Diagnostic tests for cause of chronic diarrhea began in 2019, when a trial sponsored by Napo Pharmaceuticals took place. Following positive results from the first 100 participants, Phase 4 drug approval was granted and now there are two active medical studies spanning 14 cities and one nation."

Answered by AI

Does my profile fulfill the criteria to join this clinical experiment?

"To be considered for this trial, patients must have symptoms of loose stool and are between the ages 18 to 75. The team is currently aiming to recruit 100 people in total."

Answered by AI

Who else is applying?

How old are they?
18 - 65
What portion of applicants met pre-screening criteria?
Did not meet criteria
Recent research and studies
clinicaltrials.govStudy
Yield of Diagnostic Tests and Effects of Crofelemer for Chronic Idiopathic Diarrhea In Non-HIV Patients
Brooks Cash 2019. "Yield of Diagnostic Tests and Effects of Crofelemer for Chronic Idiopathic Diarrhea In Non-HIV Patients". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT03898856.
~17 spots leftby Apr 2025
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