Clinical trial NCT03842007: Understanding Mechanisms of Normal and Disordered Defecation
Official title: Understanding Mechanisms of Normal and Disordered Defecation
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Constipation
Lead sponsor: Mayo Clinic
Sponsor class: OTHER
Collaborators: name: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
First posted: 2019-02-15
Enrollment: 160
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

Brief summary: Researchers are trying to better understand why constipation occurs and improve the tests for diagnosing these conditions.

Detailed description: Study includes a screening visit and a study day. During the initial screening visit for this study, subjects will complete three (3) questionnaires about their bowel symptoms, overall health, and anxiety and depression. A blood sample (about 4 tablespoons) will be drawn to study the relationship between genes and certain bowel habits. Subjects will be asked to provide a single stool sample to look at the bacteria in the stool.

Before the study, subjects will receive 1 to 2 Fleet's enemas to clean the rectum. After receiving the Fleet's enema (administered through a small plastic tube in the rectum), a swab attached to a small rectal catheter will be used to brush the lining of the rectum and obtain a stool specimen. Then, rectal and anal pressures will be measured by placing a small catheter (plastic tube) in the rectum, and withdrawing it slowly. Rectal sensation will be measured by inflating a small balloon in the rectum.

There are 2 procedures (rectal barostat study and fecomanoflowmetry), each of which lasts approximately 90 minutes. During the rectal barostat study, contractions will be recorded with a balloon inserted into the rectum and inflated. After the barostat study is completed, your rectum will be filled with a small amount of paste. Two thin catheters will be inserted into the anus to measure pressures and electrical activity (electromyography or EMG). Then, you will be asked to sit on a commode, contract (squeeze) your anal muscles, blow into a balloon, and expel the paste into the commode.

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.

Primary outcomes:
measure: Rectal emptying
timeFrame: Baseline
measure: Rectoanal pressures
timeFrame: Baseline
Secondary outcomes:
measure: Anal sphincter electromyography (EMG)
timeFrame: Baseline
measure: Rectal compliance measured with a barostat
timeFrame: Baseline
measure: Rectal Capacity measured with a barostat
timeFrame: Baseline
measure: Rectal contractile response to distention measured with a sinusoidal oscillator
timeFrame: Baseline
measure: Rectal sensory threshold for first sensation to defecate using barostat balloon distention
timeFrame: Baseline
measure: Rectal sensory threshold for desire to defecate using barostat balloon distention
timeFrame: Baseline
measure: Rectal sensory threshold for maximum urgency during barostat balloon distention
timeFrame: Baseline
measure: Rectal balloon expulsion time
timeFrame: Baseline
Other outcomes:
Locations:
city: Rochester
country: United States
facility: Mayo Clinic in Rochester
state: Minnesota
Study officials:
affiliation: Mayo Clinic
name: Adil E Bharucha, MD
role: PRINCIPAL_INVESTIGATOR
References: