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

Part of paid clinical trials in Boston, Massachusetts.

Sponsor
Kyle Staller, MD, MPH
Study ID
NCT05995899
Phase
PHASE4
Status
Completed

Conditions

  • IBS
  • IBS - Irritable Bowel Syndrome

Eligibility Criteria

Sex
ALL
Age
18 Years - 75 Years
Healthy Volunteers
Not accepted

Interventions

  • Tenapanor — DRUG
    IBS-C patients will ingest one capsule of tenapanor (50 mg per dose), twice daily, before breakfast and dinner for a total of 8 weeks

Study Details

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.

Key Dates

Start date
Feb 6, 2024
Status verified
Mar 2026
Primary completion
Dec 17, 2025
Completion
Dec 17, 2025

Study Design

Enrollment
36 participants (actual)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Patients with IBS-C

Primary Outcome Measure

Measuring metagenomics of stool samples using whole genome shotgun sequencing (WGS) [ Time Frame: Subjects will submit stool samples at 0 weeks, 4 weeks, and 8 weeks following treatment. ]

Locations (1)

FacilityCityStateZIPSite coordinators
Massachusetts General HospitalBostonMassachusetts02114-

Find similar trials in Boston, MA

By research site
Massachusetts General Hospital· Boston, MA

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