Health TrialsbyHealthPanel

Understanding Mechanisms of Normal and Disordered Defecation

ConditionConstipation
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-80
SponsorMayo Clinic

About this trial

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

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

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.

Disqualifiers

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).

Trial design

Design model

Parallel

Treatments tested in this trial

  • Rectal Barostat Study

    Diagnostic test

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

  • Fecoflowmetry

    Diagnostic test

    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.

Treatment groups

160 Participants
are divided into 2 treatment groups
Group A: Healthy IndividualsActive comparator 2 interventions
Group B: Constipated IndividualsActive comparator 2 interventions

Trial outcomes

Primary outcomes

1

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.

Time frame
Baseline
2

Rectoanal pressures

Measured by anorectal manometry in mmHg

Time frame
Baseline

Secondary outcomes

1

Anal sphincter electromyography (EMG)

Units - mV

Time frame
Baseline
2

Rectal compliance measured with a barostat

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

Time frame
Baseline
3

Rectal Capacity measured with a barostat

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

Time frame
Baseline
4

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.

Time frame
Baseline

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Mayo Clinic

Lead sponsor

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

Collaborator

Source ClinicalTrials.gov
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