Tenapanor for Irritable Bowel Syndrome

Phase 4

Recruiting

Research Sponsored by Kyle Staller, MD, MPH

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Rome IV criteria for IBS-C for at least 6 months

Ages 18-75 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up subjects will submit stool samples at 0 weeks, 4 weeks, and 8 weeks following treatment.

Awards & highlights

Pivotal Trial

No Placebo-Only Group

Drug Has Already Been Approved

Summary

This trial aims to understand how a medication called tenapanor affects the gut bacteria and chemicals in patients with irritable bowel syndrome with constipation (IBS-C). Tenapanor is a new medication

Who is the study for?

Adults aged 18-75 with IBS-C, as per Rome IV criteria for at least 6 months. Participants must be able to submit stool samples, follow instructions, record daily bowel habits, and have a BMI between >18.5 and <35 kg/m2. They should not make major dietary changes or use probiotics during the study.

What is being tested?

The trial is testing Tenapanor's effects on gut bacteria and metabolism in IBS-C patients over an 8-week period. Subjects will take one capsule of Tenapanor (50 mg) twice daily and provide stool samples after weeks 4 and 8.

What are the potential side effects?

Previous trials suggest that Tenapanor may lead to increased bowel movements and decreased abdominal pain; however, specific side effects are not listed here.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Select...

I have been diagnosed with constipation-predominant IBS for at least 6 months.

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I am between 18 and 75 years old.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ subjects will submit stool samples at 0 weeks, 4 weeks, and 8 weeks following treatment.

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~subjects will submit stool samples at 0 weeks, 4 weeks, and 8 weeks following treatment.

This trial's timeline: 3 weeks for screening, Varies for treatment, and subjects will submit stool samples at 0 weeks, 4 weeks, and 8 weeks following treatment. for reporting.