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Understanding Mechanisms of Normal and Disordered Defecation

Primary Purpose

Constipation

Status

Recruiting

Phase

Not Applicable

Locations

United States

Study Type

Interventional

Intervention

Rectal Barostat Study

Fecoflowmetry

About this trial

This is an interventional basic science trial for Constipation

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

Mayo Clinic in RochesterRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Arm Label

Healthy Individuals

Constipated Individuals

Arm Description

Sixty healthy individuals (20 men and 40 women) will undergo an anorectal study which comprises of a rectal barostat study followed by fecoflowmetry

60 constipated individuals (20 men and 40 women) will undergo an anorectal study which comprises of a rectal barostat study followed by fecoflowmetry

Outcomes

Primary Outcome Measures

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.

Rectoanal pressures

Measured by anorectal manometry in mmHg

Secondary Outcome Measures

Anal sphincter electromyography (EMG)

Units - mV

Rectal compliance measured with a barostat

Pressure (mmHg) corresponding to half-maximum rectal volume during rectal distention

Rectal Capacity measured with a barostat

Rectal volume (ml) at maximum distending pressure during rectal distention

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.

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.

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.

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.

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

Full Information

NCT ID

NCT03842007

First Posted

January 10, 2019

Last Updated

September 26, 2023

Sponsor

Mayo Clinic

Collaborators

National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

1. Study Identification

Unique Protocol Identification Number

NCT03842007

Brief Title

Understanding Mechanisms of Normal and Disordered Defecation

Official Title

Understanding Mechanisms of Normal and Disordered Defecation

Study Type

Interventional

2. Study Status

Record Verification Date

September 2023

Overall Recruitment Status

Recruiting

Study Start Date

January 29, 2019 (Actual)

Primary Completion Date

June 2024 (Anticipated)

Study Completion Date

June 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Mayo Clinic

Collaborators

National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Constipation

7. Study Design

Primary Purpose

Basic Science

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Non-Randomized

Enrollment

160 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Healthy Individuals

Arm Type

Active Comparator

Arm Description

Sixty healthy individuals (20 men and 40 women) will undergo an anorectal study which comprises of a rectal barostat study followed by fecoflowmetry

Arm Title

Constipated Individuals

Arm Type

Active Comparator

Arm Description

60 constipated individuals (20 men and 40 women) will undergo an anorectal study which comprises of a rectal barostat study followed by fecoflowmetry

Intervention Type

Diagnostic Test

Intervention Name(s)

Rectal Barostat Study

Intervention Description

Contractions will be recorded with a balloon inserted into the rectum and inflated

Intervention Type

Diagnostic Test

Intervention Name(s)

Fecoflowmetry

Intervention Description

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.

Primary Outcome Measure Information:

Title

Rectal emptying

Description

Time Frame

Baseline

Title

Rectoanal pressures

Description

Measured by anorectal manometry in mmHg

Time Frame

Baseline

Secondary Outcome Measure Information:

Title

Anal sphincter electromyography (EMG)

Description

Units - mV

Time Frame

Baseline

Title

Rectal compliance measured with a barostat

Description

Pressure (mmHg) corresponding to half-maximum rectal volume during rectal distention

Time Frame

Baseline

Title

Rectal Capacity measured with a barostat

Description

Rectal volume (ml) at maximum distending pressure during rectal distention

Time Frame

Baseline

Title

Rectal contractile response to distention measured with a sinusoidal oscillator

Description

Time Frame

Baseline

Title

Rectal sensory threshold for first sensation to defecate using barostat balloon distention

Description

Time Frame

Baseline

Title

Rectal sensory threshold for desire to defecate using barostat balloon distention

Description

Time Frame

Baseline

Title

Rectal sensory threshold for maximum urgency during barostat balloon distention

Description

Time Frame

Baseline

Title

Rectal balloon expulsion time

Description

During this test, the time (seconds) required to expel a water-filled rectal balloon (50 ml) will be compared between healthy people and patients

Time Frame

Baseline

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

80 Years

Accepts Healthy Volunteers

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.

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Kelly J Feuerhak

Phone

507-255-6802

Feuerhak.Kelly@mayo.edu

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Adil E Bharucha, MD

Organizational Affiliation

Mayo Clinic

Official's Role

Principal Investigator

Facility Information:

Facility Name

Mayo Clinic in Rochester

City

Rochester

State/Province

Minnesota

ZIP/Postal Code

55905

Country

United States

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Kelly J Feuerhak

Phone

507-255-6802

Feuerhak.Kelly@mayo.edu

First Name & Middle Initial & Last Name & Degree

Adil E Bharucha, MD

12. IPD Sharing Statement

Links:

URL

https://www.mayo.edu/research/clinical-trials

Description

Mayo Clinic Clinical Trials

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Understanding Mechanisms of Normal and Disordered Defecation

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