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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
Must not have
Active rectal inflammation, cancer; perianal sepsis; history of pelvic radiation, rectosigmoid surgery or inflammatory bowel disease
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline
Awards & highlights
No Placebo-Only Group

Summary

This trial involves answering health questions, providing samples, and undergoing rectal tests to understand constipation better and improve diagnosis.

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.
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.
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.

Eligibility Criteria

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
Select...
I have no active rectal issues, past major rectal surgeries, or inflammatory bowel disease.

Timeline

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

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Rectal emptying
Rectoanal pressures
Secondary study objectives
Anal sphincter electromyography (EMG)
Rectal Capacity measured with a barostat
Rectal balloon expulsion time
+5 more

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

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

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.
Mechanism Of Action
Side Effect Profile
Prior Approvals
Other Research
Common treatments for constipation include fiber supplements, laxatives, and prokinetic agents. Fiber supplements, such as psyllium, increase stool bulk and promote regular bowel movements by absorbing water. Laxatives, including osmotic agents like polyethylene glycol and stimulant laxatives like bisacodyl, work by drawing water into the intestines or stimulating bowel contractions, respectively, to facilitate stool passage. Prokinetic agents, such as lubiprostone, enhance intestinal motility by activating chloride channels, leading to increased fluid secretion and improved stool consistency. These treatments are crucial for constipation patients as they address different underlying mechanisms, providing relief from symptoms and improving quality of life.

Find a Location

Who is running the clinical trial?

National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)NIH
2,429 Previous Clinical Trials
4,322,624 Total Patients Enrolled
9 Trials studying Constipation
17,025 Patients Enrolled for Constipation
Mayo ClinicLead Sponsor
3,316 Previous Clinical Trials
2,954,311 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
~35 spots leftby Jun 2026