Recruiting

Observational Study

Sponsor:

Mayo Clinic

Code:

NCT03842007

Conditions

Constipation

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Accepted

Interventions

Rectal Barostat Study

Fecoflowmetry

Study Details

Brief summary:

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

Conditions

Constipation

Study ID

NCT03842007

Start date

Jan 29, 2019

Status verified date

Aug, 2026

Completion date

Jun, 2029

Anticipated

Primary completion date

Dec, 2028

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Accepted

Inclusion Criteria

  • 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 Criteria

  • 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.

Study Design

Enrollment

160 participants

Anticipated

Allocation

Non randomized

Intervention Model

Parallel Assignment

Primary purpose

Basic Science

Interventions and Outcome Measures

Arms

active comparator: Healthy Individuals

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

active comparator: Constipated Individuals

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

Interventions

Rectal Barostat Study

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

Fecoflowmetry

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.

Primary outcome measure

  • Rectal emptying [ Time Frame: Baseline ]
  • Rectoanal pressures [ Time Frame: Baseline ]

Central Contacts and Locations

Central contacts

Kelly J Feuerhak

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

Locations

Mayo Clinic in Rochester

Recruiting

Rochester, Minnesota, United States, 55905

Contacts

Kelly J Feuerhak

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

Principal Investigator:

Adil E Bharucha, MD

More Information

Sponsor

Mayo Clinic

Last update posted

Aug 21, 2026

Last verified

Aug, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Mayo Clinic on 2026-08-21.