Understanding why constipation happens and improving diagnosis

Understanding Mechanisms of Normal and Disordered Defecation

This study is trying to find out why constipation happens and improve how it's diagnosed by looking at bowel habits and taking samples from people who have this issue.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 160 (estimated)
• Ages: 18 Years to 80 Years
• Sex: All
• Sponsor: Mayo Clinic (Academic / other)
• Drugs / interventions: radiation
• Locations: 1 site (Rochester, Minnesota)
• Trial ID: NCT03842007 on ClinicalTrials.gov

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.

Who should consider this trial

Good fit: Ideal candidates are adults aged 18-80 with chronic constipation and specific bowel symptoms lasting at least three months.

Not a fit: Patients with significant underlying health conditions that could interfere with the study's objectives may not benefit from participation.

Why it matters

Potential benefit: If successful, this study could lead to improved diagnostic methods and treatments for patients suffering from chronic constipation.

How similar studies have performed: Other studies have explored similar mechanisms of bowel function, but this specific approach to understanding constipation is relatively novel.

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.

Where this trial is running

Rochester, Minnesota

• Mayo Clinic in Rochester — Rochester, Minnesota, United States (Recruiting)

Study contacts

• Principal investigator: Adil E Bharucha, MD — Mayo Clinic
• Study coordinator: Kelly J Feuerhak

Conditions Constipation