Understanding Mechanisms of Normal and Disordered Defecation

NCT03842007 | Recruiting

• 2 other identifiers: 18-010327R01DK078924
• Study Type: interventional
• Target: 160
• Locations: 1 country
• Sites: 1

Brief Summary

Researchers are trying to better understand why constipation occurs and improve the tests for diagnosing these conditions.

Conditions

Constipation

Outcome Measures

Primary Outcomes (2)

• Rectal emptying

  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.

  Baseline

• Rectoanal pressures

  Measured by anorectal manometry in mmHg

  Baseline

Secondary Outcomes (8)

• Anal sphincter electromyography (EMG)

  Baseline

• Rectal compliance measured with a barostat

  Baseline

• Rectal Capacity measured with a barostat

  Baseline

• Rectal contractile response to distention measured with a sinusoidal oscillator

  Baseline

• Rectal sensory threshold for first sensation to defecate using barostat balloon distention

  Baseline

Study Arms (2)

Healthy Individuals

ACTIVE COMPARATOR

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

Diagnostic Test: Rectal Barostat Study; Diagnostic Test: Fecoflowmetry

Constipated Individuals

ACTIVE COMPARATOR

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

Diagnostic Test: Rectal Barostat Study; Diagnostic Test: Fecoflowmetry

Interventions

Rectal Barostat Study DIAGNOSTIC_TEST

Contractions will be recorded with a balloon inserted into the rectum and inflated

Constipated Individuals; Healthy Individuals

Fecoflowmetry DIAGNOSTIC_TEST

Rectum will be filled with a small amount of paste.Two thin catheters will be inserted into the anus to measure pressures and electrical activity (electromyography or EMG). Subjects will be asked to sit on a commode, contract (squeeze) your anal muscles, blow into a balloon, and expel the paste into the commode.

Constipated Individuals; Healthy Individuals

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Mayo Clinic: lead
• National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK): collaborator

Study Sites (1)

Mayo Clinic in Rochester

Rochester, Minnesota, 55905, United States

RECRUITING

Related Links

• Mayo Clinic Clinical Trials

MeSH Terms

Conditions

Constipation

Condition Hierarchy (Ancestors)

Signs and Symptoms, Digestive; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Adil E Bharucha, MD

  Mayo Clinic

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Kelly J Feuerhak

CONTACT

507-255-6802; Feuerhak.Kelly@mayo.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: January 10, 2019
• First Posted: February 15, 2019
• Study Start: January 29, 2019
• Primary Completion (Estimated): June 1, 2026
• Study Completion (Estimated): June 1, 2026
• Last Updated: August 5, 2025

Record last verified: 2025-08

Locations

US (1)