NCT03842007 Understanding Mechanisms of Normal and Disordered Defecation
| NCT ID | NCT03842007 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Mayo Clinic |
| Condition | Constipation |
| Study Type | INTERVENTIONAL |
| Enrollment | 160 participants |
| Start Date | 2019-01-29 |
| Primary Completion | 2026-06 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 160 participants in total. It began in 2019-01-29 with a primary completion date of 2026-06.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
Researchers are trying to better understand why constipation occurs and improve the tests for diagnosing these conditions.
Eligibility Criteria
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.
Contact & Investigator
Adil E Bharucha, MD
PRINCIPAL INVESTIGATOR
Mayo Clinic
Frequently Asked Questions
Who can join the NCT03842007 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 80 Years, studying Constipation. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT03842007 currently recruiting?
Yes, NCT03842007 is actively recruiting participants. Contact the research team at Feuerhak.Kelly@mayo.edu for enrollment information.
Where is the NCT03842007 trial being conducted?
This trial is being conducted at Rochester, United States.
Who is sponsoring the NCT03842007 clinical trial?
NCT03842007 is sponsored by Mayo Clinic. The principal investigator is Adil E Bharucha, MD at Mayo Clinic. The trial plans to enroll 160 participants.