Evaluating normal values for anorectal function measurements

EvaluatIng Normal Values for traditionaL anorectaL fUnction paraMeters With aIr Charged aNd Solid State HRAM catheTErs ("ILLUMINATE" Study)

This study is trying to find out what normal anorectal function looks like by testing two different types of manometry catheters in healthy people.

Quick facts

• Study type: Observational
• Enrollment: 81 (estimated)
• Ages: 18 Years to 65 Years
• Sex: All
• Sponsor: Laborie Medical Technologies Inc. (industry)
• Drugs / interventions: radiation
• Locations: 3 sites (Augusta, Georgia and 2 other locations)
• Trial ID: NCT06805240 on ClinicalTrials.gov

What this trial studies

This research aims to establish baseline normative data for traditional anorectal function measurements using both air charged and solid state high-resolution anorectal manometry (HRAM) catheters. The study will utilize the IAPWG standardized testing protocol and London classification to compare the performance of these two types of catheters in healthy subjects. By gathering this data, the study seeks to enhance understanding of normal anorectal function parameters.

Who should consider this trial

Good fit: Ideal candidates for this study are healthy male and female volunteers aged 18-65 who can provide informed consent.

Not a fit: Patients with a documented history of gastrointestinal disorders or those on medications affecting gastrointestinal motility may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could provide valuable normative data that may improve the diagnosis and treatment of anorectal disorders.

How similar studies have performed: While this approach is focused on establishing normative data, similar studies have successfully utilized HRAM techniques to assess anorectal function.

Eligibility criteria

Inclusion Criteria:

* 1\. Male and female volunteers, 18-65 years old
* 2\. Willing to provide informed consent
* 3\. Willing and able to follow instructions for ARM procedure

Exclusion Criteria:

* 1\. Documented history of gastrointestinal disorders such as:
* a. fecal incontinence,
* b. irritable bowel syndrome (IBS),
* c. functional constipation, as defined by two or more of these symptoms for at least 25% of the time over the past 3 months:
* i. excessive straining,
* ii. hard or lumpy stools,
* iii. sensation of incomplete evacuation,
* iv. a feeling of anorectal blockage,
* v. manual maneuvers to facilitate defecation,
* vi. or fewer than 3 bowel movements per week.
* d. functional diarrhea, as defined by the following symptoms over the past 3 months:
* i. Loose or watery stools
* ii. Lack of pain with diarrhea
* iii. Diarrhea occurring in at least 75% of bowel movements
* iv. No identifiable causes
* 2\. Use of medications that may affect gastrointestinal motility as determined by healthcare professional.
* 3\. Prior pelvic radiation,
* 4\. Prior anorectal surgical procedures, including treatment for hemorrhoids,
* 5\. Risk factors for pelvic floor trauma:
* a. more than 4 vaginal deliveries,
* b. vaginal delivery with birthweight greater than 4500gms (macrosomia),
* c. known 4th degree perineal tear or known forceps use during delivery.
* 6\. Contraindicated for ARM testing
* 7\. Has gastrointestinal symptoms and is indicated for ARM testing
* 8\. Subject is currently pregnant or plans to become pregnant during the course of their enrollment in the study, as self-reported.

Where this trial is running

Augusta, Georgia and 2 other locations

• Augusta University Digestive Health Center — Augusta, Georgia, United States (RECRUITING)
• Southwest Gastroenterology — New Lenox, Illinois, United States (ACTIVE_NOT_RECRUITING)
• Digestive Health Center of the Four States, LLC — Joplin, Missouri, United States (ACTIVE_NOT_RECRUITING)

Study contacts

• Study coordinator: Robert Wroblewski

Conditions: Healthy, ARM procedure, ARM measurement, asymptomatic, anorectal function, anorectal