drugset / Trial / NCT05995899

Effect of Tenapanor on the Metagenomics and Metabolomics of Patients With Irritable Bowel Syndrome With Constipation

NCT05995899

Phase 4 Completed 36 enrolled Kyle Staller, MD, MPH Ardelyx · collab
NaSingle-groupOpen-labelTreatment

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.

Timeline

Start
2024-02-06
Primary completion
2025-12-17
Completion
2025-12-17

Drugs

EvaluationDrugModalityDoseRoute
Subject Tenapanor Small molecule 50 mg Oral