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Understanding Mechanisms of Normal and Disordered Defecation

This study aims to better understand why constipation happens and to improve the tests used to diagnose it. Researchers will use two main diagnostic tests: a Rectal Barostat Study, where a balloon is inserted into your rectum and inflated to record contractions, and Fecoflowmetry, which involves filling your rectum with a paste and using thin catheters to measure pressures and electrical activity (EMG). The study is looking for 160 participants, aged 18 to 80, who have experienced chronic constipation for at least one year with specific symptoms. The main goals are to measure how well the rectum empties and the pressures in the rectum and anus.

Study design
This is an interventional study with a planned enrollment of 160 participants. It is not specified if it is randomized or blinded.
What's involved
You will have a screening visit and a study day. This includes questionnaires, a blood sample, a stool sample, enemas, rectal brushing, and two 90-minute procedures (Rectal Barostat Study and Fecoflowmetry).
Compensation
Not stated in the trial record.
Follow-up
Rectal emptying and rectoanal pressures are measured at Baseline, but no further follow-up timeframes are specified.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT03842007

Understanding Mechanisms of Normal and Disordered Defecation

Recruiting
NAAges 18–80InterventionalBasic science
Mayo Clinic
~160 participants
Updated 2026-08-21 on ClinicalTrials.gov
What's tested:Rectal Barostat StudyFecoflowmetry

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Rectal emptying
Measured over Baseline
+1 more outcome measured

Conditions

Constipation

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NCT03842007

Where you'd take part

This study runs at 1 site. They're the same protocol — you choose where, and that choice sets who your contact draft is addressed to.

  • Mayo Clinic in Rochester

    Rochester, Minnesotastudy coordinator listed

    Recruiting

Sites open and close at different times, so the status above is per site — it can differ from the study's overall status.

Study leadership

  • Adil E Bharucha, MD · PRINCIPAL_INVESTIGATOR · Mayo Clinic

Who to contact

Kelly J Feuerhak
[email protected]
507-255-6802
Email the study team

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Eligibility criteria

Inclusion

Male and female volunteers aged 18-80 years.
Able to provide written informed consent before participating in the study.
Able to communicate adequately with the investigator and to comply with the requirements for the entire study.
Individuals with chronic constipation for 1 year, with 2 or more of the following symptoms for 3 months or longer: \<3 bowel motions/week, straining ≥ 25% of time, hard or lumpy stools ≥ 25% of time, anal digitation ≥ 25% of time, incomplete evacuation ≥ 25% of time, feeling of anorectal blockage ≥ 25% of time.
Able to provide written informed consent before participating in the study.
Able to communicate adequately with the investigator and to comply with the requirements for the entire study.

Exclusion

Clinical evidence of significant cardiovascular, respiratory, renal, hepatic, gastrointestinal, hematological, neurological, psychiatric or other disease that may interfere with the objectives of the study and/or pose safety concerns.
Current symptoms of a functional gastrointestinal disorder assessed by questionnaire.
Putative risk factors for pelvic floor trauma: i.e. six or more vaginal deliveries, birthweight \>4500gms (macrosomia), or known 3rd or 4th degree perineal tear.
Medications that are likely to alter gastrointestinal motility: e.g., opiates and anticholinergic medications; a stable dose of thyroxine and low doses of tricyclic agents (e.g., up to amitriptyline (50 mg daily).
Active rectal inflammation, cancer; perianal sepsis; history of pelvic radiation, rectosigmoid surgery or inflammatory bowel disease.\*
Anxiety or depression as assessed by the Hospital Anxiety and Depression Questionnaire.
Pregnant women, prisoners and institutionalized individuals.

What this trial measures

  • Rectal emptyingBaseline

    Measured by fecomanoflowmetry calculating the mean and maximum flow rate in various conditions (mg/sec), defecated volume (mg), flow time (sec) and time to maximum flow (sec). The amount of artificial stool evacuated is expressed in milligrams. The duration is in seconds. These 2 metrics are integrated to measure mg evacuated/second.

  • Rectoanal pressuresBaseline

    Measured by anorectal manometry in mmHg