Understanding why constipation happens and improving diagnosis

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This study aims to investigate the mechanisms behind normal and disordered defecation, specifically focusing on constipation. Participants will undergo a screening visit where they will complete questionnaires about their bowel symptoms and provide blood and stool samples for analysis. The study includes two main procedures: a rectal barostat study to measure rectal contractions and a fecoflowmetry to assess rectal pressures and electrical activity. These assessments will help researchers better understand the relationship between genetics, bowel habits, and the underlying causes of constipation.

Why it matters

Who can join: the full rules

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.

Where it's running

• Mayo Clinic in Rochester
  Rochester, Minnesota, United States Recruiting

Study contacts

• Principal investigator: Adil E Bharucha, MD — Mayo Clinic
• Study coordinator: Kelly J Feuerhak
• Email: Feuerhak.Kelly@mayo.edu
• Phone: 507-255-6802

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.