Actively Recruiting

Phase Not Applicable
Age: 18Years - 80Years
All Genders
Healthy Volunteers
NCT03842007

Understanding Mechanisms of Normal and Disordered Defecation

Led by Mayo Clinic · Updated on 2025-08-05

160

Participants Needed

1

Research Sites

382 weeks

Total Duration

On this page

Sponsors

M

Mayo Clinic

Lead Sponsor

N

National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Collaborating Sponsor

AI-Summary

What this Trial Is About

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

CONDITIONS

Official Title

Understanding Mechanisms of Normal and Disordered Defecation

Who Can Participate

Age: 18Years - 80Years
All Genders
Healthy Volunteers

Eligibility Criteria

Eligible

You may qualify if you...

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.
Not Eligible

You will not qualify if you...

History of severe allergic reactions to study medication Currently pregnant or breastfeeding Recent participation in another clinical trial within the last 30 days Presence of uncontrolled medical conditions that could affect safety

AI-Screening

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Trial Site Locations

Total: 1 location

1

Mayo Clinic in Rochester

Rochester, Minnesota, United States, 55905

Actively Recruiting

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Research Team

K

Kelly J Feuerhak

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NON_RANDOMIZED

Model

PARALLEL

Primary Purpose

BASIC_SCIENCE

Number of Arms

2

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Understanding Mechanisms of Normal and Disordered Defecation | DecenTrialz