Understanding Mechanisms of Normal and Disordered Defecation

Constipation Clinical Trial

Official title:

Understanding Mechanisms of Normal and Disordered Defecation

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03842007
• Other study ID #: 18-010327
• Secondary ID: R01DK078924
• Status: Recruiting
• Phase: N/A
• Start date: January 29, 2019
• Est. completion date: June 2024

Study information

• Verified date: September 2023
• Source: Mayo Clinic
• Contact: Kelly J Feuerhak
• Phone: 507-255-6802
• Email: Feuerhak.Kelly[@]mayo.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• 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.

Related Conditions & MeSH terms

• Constipation

Intervention

Diagnostic Test:
• Rectal Barostat Study
Contractions will be recorded with a balloon inserted into the rectum and inflated
• Fecoflowmetry
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.

Locations

Country	Name	City	State
United States	Mayo Clinic in Rochester	Rochester	Minnesota

Sponsors (2)

Lead Sponsor	Collaborator
Mayo Clinic	National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Country where clinical trial is conducted

United States, 

Outcome

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

External Links

•   Mayo Clinic Clinical Trials