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 range18 Years – 75 Years
SexALL
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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
Exclusion criteria
✕. History of loose stools
✕. History of irritable bowel syndrome with diarrhea (IBS-D) or mixed irritable bowel syndrome (IBS-M)
✕
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.