Actively Recruiting
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
Eligibility Criteria
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.
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
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Trial Site Locations
Total: 1 location
1
Mayo Clinic in Rochester
Rochester, Minnesota, United States, 55905
Actively Recruiting
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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