Constipation
Conditions
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.
Interventions
DIAGNOSTIC_TESTRectal Barostat Study
Contractions will be recorded with a balloon inserted into the rectum and inflated
DIAGNOSTIC_TESTFecoflowmetry
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). Subjects will be asked to sit on a commode, contract (squeeze) your anal muscles, blow into a balloon, and expel the paste into the commode.
Sponsors
Mayo Clinic
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
BASIC_SCIENCE
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
Yes
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Rectal emptying | Baseline | 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. |
| Rectoanal pressures | Baseline | Measured by anorectal manometry in mmHg |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Anal sphincter electromyography (EMG) | Baseline | Units - mV |
| Rectal compliance measured with a barostat | Baseline | Pressure (mmHg) corresponding to half-maximum rectal volume during rectal distention |
| Rectal Capacity measured with a barostat | Baseline | Rectal volume (ml) at maximum distending pressure during rectal distention |
| Rectal contractile response to distention measured with a sinusoidal oscillator | Baseline | 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. |
| Rectal sensory threshold for first sensation to defecate using barostat balloon distention | Baseline | 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. |
| Rectal sensory threshold for desire to defecate using barostat balloon distention | Baseline | 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. |
| Rectal sensory threshold for maximum urgency during barostat balloon distention | Baseline | 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. |
| Rectal balloon expulsion time | Baseline | During this test, the time (seconds) required to expel a water-filled rectal balloon (50 ml) will be compared between healthy people and patients |
Countries
United States
Contacts
CONTACTKelly J Feuerhak
PRINCIPAL_INVESTIGATORAdil E Bharucha, MD
Mayo Clinic
Outcome results
None listed