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Assessing Uniqueness of Inflammatory Bowel Disease Related Microbiome-derived Biomarkers

NCT05640583 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 20

Last updated 2023-04-27

No results posted yet for this study

Summary

To assess the differential expression of IBD-related microbiome-derived biomarkers including bacterial strains and peptides such as antimicrobial peptides (AMP) found in inner-colonic samples (HygiSample™) in comparison to home collected stool samples in patients with active IBD colonic disease.

The HygiSample will be collected during a defecation-inducing high-volume (\>40 L) colon irrigation bowel prep (HygiPrepⓇ).

Conditions

  • Irritable Bowel Disease

Interventions

DEVICE

Hygieacare System

The device is an FDA cleared colon irrigation device, it will be used according to clearance. The sampling of the colon effluent sampled is the are of study.

Sponsors & Collaborators

  • HyGIeaCare, Inc.

    lead INDUSTRY

Principal Investigators

  • David A Johnson, MD · Digestive & Liver Disease Specialists

Study Design

Allocation
NON_RANDOMIZED
Purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2022-03-16
Primary Completion
2023-03-06
Completion
2023-03-06
FDA Device
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05640583 on ClinicalTrials.gov