Effect of Tenapanor on the Metagenomics and Metabolomics of Patients With Irritable Bowel Syndrom… (NCT05995899) | Clinical Trial Compass
CompletedPhase 4
Effect of Tenapanor on the Metagenomics and Metabolomics of Patients With Irritable Bowel Syndrome With Constipation
United States36 participantsStarted 2024-02-06
Plain-language summary
The aim of this study is to better understand how tenapanor affects the metagenomics and metabolomics of patients with irritable bowel syndrome with constipation (IBS-C). Tenapanor is the newest FDA-approved agent for IBS-C. It is a small molecule that inhibits the NHE3 receptor, leading to impaired sodium and water absorption in the intestine. Previous clinical trials comparing tenapanor to placebo showed that a 50 mg dose of tenapanor led to increased bowel movements and decreased abdominal pain. This study consists of an 8-week treatment period in which subjects will ingest one capsule of tenapanor (50 mg per dose), twice daily, and send in stool samples following 4 weeks and 8 weeks of treatment.
Who can participate
Age range
18 Years – 75 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. Ages 18-75 years old
. BMI \>18.5 and \<35 kg/m2
. Rome IV criteria for IBS-C for at least 6 months
. Compliant with baseline stool submission prior to initiation of medication
. Ability to follow verbal and written instructions
. Ability to record daily bowel habits, including frequency, stool consistency (BSFS), and symptom severity
. Willingness to avoid major dietary changes and use of probiotics during the study period
. Informed consent form signed by the subjects
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Measuring metagenomics of stool samples using whole genome shotgun sequencing (WGS)
Timeframe: Subjects will submit stool samples at 0 weeks, 4 weeks, and 8 weeks following treatment.
2
Measuring metabolomics of stool samples using the DiscoveryHD4TM Platform
Timeframe: Subjects will submit stool samples at 0 weeks, 4 weeks, and 8 weeks following treatment.