Healthy Individuals for Dyschezia

Phase-Based Progress Estimates
1
Effectiveness
1
Safety
Dyschezia
Fecoflowmetry - DiagnosticTest
Eligibility
18+
All Sexes
What conditions do you have?
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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.

Treatment Effectiveness

Effectiveness Progress

1 of 3

Study Objectives

2 Primary · 8 Secondary · Reporting Duration: Baseline

Baseline
Anal sphincter electromyography (EMG)
Rectal Capacity measured with a barostat
Rectal balloon expulsion time
Rectal compliance measured with a barostat
Rectal contractile response to distention measured with a sinusoidal oscillator
Rectal emptying
Rectal sensory threshold for desire to defecate using barostat balloon distention
Rectal sensory threshold for first sensation to defecate using barostat balloon distention
Rectal sensory threshold for maximum urgency during barostat balloon distention
Rectoanal pressures

Trial Safety

Trial Design

2 Treatment Groups

Healthy Individuals
1 of 2
Constipated Individuals
1 of 2

Active Control

160 Total Participants · 2 Treatment Groups

Primary Treatment: Healthy Individuals · No Placebo Group · N/A

Healthy IndividualsActiveComparator Group · 2 Interventions: Fecoflowmetry, Rectal Barostat Study · Intervention Types: DiagnosticTest, DiagnosticTest
Constipated IndividualsActiveComparator Group · 2 Interventions: Fecoflowmetry, Rectal Barostat Study · Intervention Types: DiagnosticTest, DiagnosticTest

Trial Logistics

Trial Timeline

Screening: ~3 weeks
Treatment: Varies
Reporting: baseline

Who is running the clinical trial?

National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)NIH
2,125 Previous Clinical Trials
4,062,958 Total Patients Enrolled
Mayo ClinicLead Sponsor
2,896 Previous Clinical Trials
3,699,161 Total Patients Enrolled
Adil E Bharucha, MDPrincipal InvestigatorMayo Clinic
1 Previous Clinical Trials
150 Total Patients Enrolled

Eligibility Criteria

Age 18+ · All Participants · 4 Total Inclusion Criteria

Mark “Yes” if the following statements are true for you:
You are either male or female and are aged between 18 and 80 years.
You are able to communicate adequately with the investigator and to comply with the requirements for the entire study.

About The Reviewer

Michael Gill preview

Michael Gill - B. Sc.

First Published: October 6th, 2021

Last Reviewed: November 21st, 2022

Michael Gill holds a Bachelors of Science in Integrated Science and Mathematics from McMaster University. During his degree he devoted considerable time modeling the pharmacodynamics of promising drug candidates. Since then, he has leveraged this knowledge of the investigational new drug ecosystem to help his father navigate clinical trials for multiple myeloma, an experience which prompted him to co-found Power Life Sciences: a company that helps patients access randomized controlled trials.