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Diagnostic Tests for Gut Transit in Constipation

N/A

Recruiting

Led By Adil E Bharucha, MD

Research Sponsored by Mayo Clinic

Eligibility Criteria Checklist

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

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up baseline

Awards & highlights

Study Summary

This trial is testing a new way to measure gut transit times to see if it can help explain why some people experience constipation.

Who is the study for?

This trial is for men and women aged 18-80 who've had chronic constipation for at least a year, with symptoms like fewer than three bowel movements per week or the feeling of incomplete evacuation. It's not open to pregnant individuals, prisoners, those with significant health issues that could interfere with the study, or anyone on medications affecting gastrointestinal motility.Check my eligibility

What is being tested?

The study aims to understand constipation better by using two tests: Fecoflowmetry and Rectal Barostat Study. These tests measure how well stool moves through the body and how sensitive the rectum is, which might help diagnose defecation disorders more accurately.See study design

What are the potential side effects?

Since this trial involves diagnostic procedures rather than medication or invasive treatments, side effects are minimal but may include temporary discomfort during testing.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ baseline

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~baseline

This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline for reporting.

Treatment Details

Study Objectives

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

Primary outcome measures

Rectal emptying

Rectoanal pressures

Secondary outcome measures

Anal sphincter electromyography (EMG)

Rectal Capacity measured with a barostat

Rectal balloon expulsion time

+5 more

Trial Design

2Treatment groups

Active Control

Group I: Healthy IndividualsActive Control2 Interventions

Sixty healthy individuals (20 men and 40 women) will undergo an anorectal study which comprises of a rectal barostat study followed by fecoflowmetry

Group II: Constipated IndividualsActive Control2 Interventions

60 constipated individuals (20 men and 40 women) will undergo an anorectal study which comprises of a rectal barostat study followed by fecoflowmetry

Do I qualify?Apply below to find out

Find a Location

Who is running the clinical trial?

National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)NIH

2,359 Previous Clinical Trials

4,315,134 Total Patients Enrolled

9 Trials studying Constipation

17,025 Patients Enrolled for Constipation

Mayo ClinicLead Sponsor

3,211 Previous Clinical Trials

3,766,838 Total Patients Enrolled

14 Trials studying Constipation

469 Patients Enrolled for Constipation

Adil E Bharucha, MDPrincipal InvestigatorMayo Clinic

1 Previous Clinical Trials

150 Total Patients Enrolled

Media Library

Healthy Individuals Clinical Trial Eligibility Overview. Trial Name: NCT03842007 — N/A

Constipation Research Study Groups: Healthy Individuals, Constipated Individuals

Constipation Clinical Trial 2023: Healthy Individuals Highlights & Side Effects. Trial Name: NCT03842007 — N/A

Healthy Individuals 2023 Treatment Timeline for Medical Study. Trial Name: NCT03842007 — N/A

Frequently Asked Questions

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

Is eligibility for this trial limited to individuals below a certain age?

"Following the set of requirements for eligibility, this medical trial is open to those aged 18 and above up to 80 years old."

Answered by AI

To whom is this research opportunity open?

"The prerequisites for this clinical trial are dyschezia and age within the range of 18 to 80 years old. Currently, there is a need for 160 participants."

Answered by AI

Is the recruitment process still underway for this clinical trial?

"This medical research is actively recruiting according to clinicaltrials.gov, having first been posted on January 29th of 2019 and most recently amended on September 19th 2022."

Answered by AI

What type of outcomes is this research endeavor hoping to yield?

"This trial, which will span a defined period of time known as the Baseline, seeks to evaluate Rectoanal pressures. Secondary objectives include measuring Rectal Capacity with a barostat (the amount of volume in ml achieved at maximum distention pressure), determining the sensory threshold for defecation while using incremental balloon inflation between 0 and 44 mm Hg (in 4mmHg increments) through participant-reported desire to defecate, and analyzing Rectal Compliance by recording Pressure values corresponding to half-maximum rectum capacity during distension."

Answered by AI

How many subjects are participating in this research endeavor?

"Affirmative. As per the information provided on clinicaltrials.gov, this experiment is presently looking for participants and was initially published on 29th January 2019 with a last update from 19th September 2022. 160 people will be recruited at one site to participate in the trial."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Understanding Mechanisms of Normal and Disordered Defecation

Adil Bharucha, MBBS, MD 2019. "Understanding Mechanisms of Normal and Disordered Defecation". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT03842007.

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