Understanding Mechanisms of Normal and Disordered Defecation
ConditionConstipation
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-80
SponsorMayo Clinic
About this trial
Researchers are trying to better understand why constipation occurs and improve the tests for diagnosing these conditions.
Eligibility criteria
Qualifiers
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.
Disqualifiers
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).
Trial design
Treatments tested in this trial
- Rectal Barostat Study
- Fecoflowmetry
Treatment groups
160 Participants
are divided into 2 treatment groupsSponsors and collaborators
Mayo Clinic
Lead sponsor
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Collaborator
Source ClinicalTrials.gov