Constipation Clinical Trial
Official title:
Understanding Mechanisms of Normal and Disordered Defecation
Researchers are trying to better understand why constipation occurs and improve the tests for diagnosing these conditions.
Status | Recruiting |
Enrollment | 160 |
Est. completion date | June 2024 |
Est. primary completion date | June 2024 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 18 Years to 80 Years |
Eligibility | 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. |
Country | Name | City | State |
---|---|---|---|
United States | Mayo Clinic in Rochester | Rochester | Minnesota |
Lead Sponsor | Collaborator |
---|---|
Mayo Clinic | National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Rectal emptying | Measured by fecomanoflowmetry calculating the mean and maximum flow rate in various conditions (mg/sec), defecated volume (mg), flow time (sec) and time to maximum flow (sec). The amount of artificial stool evacuated is expressed in milligrams. The duration is in seconds. These 2 metrics are integrated to measure mg evacuated/second. | Baseline | |
Primary | Rectoanal pressures | Measured by anorectal manometry in mmHg | Baseline | |
Secondary | Anal sphincter electromyography (EMG) | Units - mV | Baseline | |
Secondary | Rectal compliance measured with a barostat | Pressure (mmHg) corresponding to half-maximum rectal volume during rectal distention | Baseline | |
Secondary | Rectal Capacity measured with a barostat | Rectal volume (ml) at maximum distending pressure during rectal distention | Baseline | |
Secondary | Rectal contractile response to distention measured with a sinusoidal oscillator | Rectal balloon is inflated to a preload volume of 125ml. The balloon is then oscillated around baseline volume by 25mL for 20 min at a frequency of 5 counts per minute (cpm). The mean rectal pressure (cm H2O) will be calculated over the multiple oscillation cycles within the 20 minute distention segment. | Baseline | |
Secondary | Rectal sensory threshold for first sensation to defecate using barostat balloon distention | The sensory threshold for first sensation to defecate is measured by stepwise inflation of the balloon (0-44 mm Hg, at 4 mm Hg increments). During this assessment participants are asked to report when they have the first sensation to defecate. | Baseline | |
Secondary | Rectal sensory threshold for desire to defecate using barostat balloon distention | The sensory threshold for desire to defecate is measured by stepwise inflation of the balloon (0-44 mm Hg, at 4 mm Hg increments). During this assessment participants are asked to report when they have the desire to defecate. | Baseline | |
Secondary | Rectal sensory threshold for maximum urgency during barostat balloon distention | The sensory threshold for maximum urgency to defecate is measured by stepwise inflation of the balloon (0-44 mm Hg, at 4 mm Hg increments). During this assessment participants are asked to report when they have the maximum urgency to defecate. | Baseline | |
Secondary | Rectal balloon expulsion time | During this test, the time (seconds) required to expel a water-filled rectal balloon (50 ml) will be compared between healthy people and patients | Baseline |
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