Understanding Mechanisms of Normal and Disordered Defecation
Recruiting now · Not applicable
Conditions studied: Constipation
In brief
Researchers are trying to better understand why constipation occurs and improve the tests for diagnosing these conditions.
Key facts
- Study ID
- NCT03842007
- Run by
- Mayo Clinic
- People needed
- 160
- Starts
- 2019-01-29
- Expected to finish
- 2026-06-01
- Last updated by the study team
- 2025-08-05
Who can join
Age: 18 and older, up to 80. Sex: any. Healthy volunteers: accepted.
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.
Where it is running
- Mayo Clinic in Rochester — Rochester, Minnesota, United States (enrolling)
Full record on ClinicalTrials.gov
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