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Small Molecule Inhibitor

Patients with IBS-C for Irritable Bowel Syndrome

Q: Are there any available positions for patients to participate in this clinical trial?

Indeed, the information available on clinicaltrials.gov confirms that this study is actively seeking eligible participants. The study was initially posted on December 1st, 2023 and last updated on December 22nd, 2023. In order to complete the trial successfully, researchers are aiming to recruit a total of 30 patients from one specific location.

Q: Is the age requirement for participation in this study set at 20 years or above?

As specified in the eligibility criteria for this clinical study, participants must meet the age requirements of being at least 18 years old and no more than 75 years old.

Q: To what extent do individuals with irritable bowel syndrome with constipation pose a risk to others?

Based on the designation of this trial as Phase 4, indicating that the treatment has already received approval, our team at Power rates the safety of patients with <a href="https://www.withpower.com/clinical-trials/ibs">IBS</a>-C as a 3.

Q: What is the current number of individuals enrolled in this clinical research study?

Indeed, the information found on clinicaltrials.gov indicates that this particular clinical trial is actively seeking eligible participants. The study was initially posted on December 1st, 2023 and underwent its last revision on December 22nd, 2023. To complete the trial successfully, a total of 30 patients will be enrolled from a single designated site.

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

Study 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.Check my eligibility

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.See study design

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.

Select...

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.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Measuring metabolomics of stool samples using the DiscoveryHD4TM Platform

Measuring metagenomics of stool samples using whole genome shotgun sequencing (WGS)

Side effects data

From 2021 Phase 4 trial • 333 Patients • NCT04549597

42%

Diarrhea

Covid-19

Pneumonia

Peritonitis

Chest Pain

Hypoglycemia

Hyperkalemia

Fluid Overload

Cerebrovascular Accident

Arteriovenous Fistula Site Infection

Catheter Site Infection

Influenza

Ulna Fracture

Nausea

100%

80%

60%

40%

20%

Study treatment Arm

Cohort 2

Cohort 3: Phosphate Binder Naïve

Cohort 1

Trial Design

1Treatment groups

Experimental Treatment

Group I: Patients with IBS-CExperimental Treatment1 Intervention

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Tenapanor

2016

Completed Phase 4

~4030

0 / 2Eligibility criteria met

Find a Location

Who is running the clinical trial?

Kyle Staller, MD, MPHLead Sponsor

ArdelyxIndustry Sponsor

27 Previous Clinical Trials

5,983 Total Patients Enrolled

7 Trials studying Irritable Bowel Syndrome

2,383 Patients Enrolled for Irritable Bowel Syndrome

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are there any available positions for patients to participate in this clinical trial?

"Indeed, the information available on clinicaltrials.gov confirms that this study is actively seeking eligible participants. The study was initially posted on December 1st, 2023 and last updated on December 22nd, 2023. In order to complete the trial successfully, researchers are aiming to recruit a total of 30 patients from one specific location."

Answered by AI

Is the age requirement for participation in this study set at 20 years or above?

"As specified in the eligibility criteria for this clinical study, participants must meet the age requirements of being at least 18 years old and no more than 75 years old."

Answered by AI

To what extent do individuals with irritable bowel syndrome with constipation pose a risk to others?

"Based on the designation of this trial as Phase 4, indicating that the treatment has already received approval, our team at Power rates the safety of patients with IBS-C as a 3."

Answered by AI

What is the current number of individuals enrolled in this clinical research study?

"Indeed, the information found on clinicaltrials.gov indicates that this particular clinical trial is actively seeking eligible participants. The study was initially posted on December 1st, 2023 and underwent its last revision on December 22nd, 2023. To complete the trial successfully, a total of 30 patients will be enrolled from a single designated site."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

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

Kyle Staller, MD, MPH 2024. "Effect of Tenapanor on the Metagenomics and Metabolomics of Patients With Irritable Bowel Syndrome With Constipation". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05995899.

All > Irritable Bowel Syndrome > Ibs