Assessing Uniqueness of Inflammatory Bowel Disease Related Microbiome-derived Biomarkers

HyGIeaCare

Status: Completed

Conditions: Irritable Bowel Disease

Treatments: Device: Hygieacare System

Study type: Interventional

Funder types: Industry

Identifiers

NCT05640583

HGP-0011

Details and patient eligibility

About

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Ⓡ).

Full description

This study is a preliminary study aimed to assess the ability to differentially detect IBD-related microbiome-derived biomarkers in colon effluent samples collected using the Hygieacare System. The proposed sample size of 20 patients (10 in the control arm, 10 in the IBD arm), where each patient provides both stool and three inner-colonic samples is sufficient to provide preliminary results for such an assessment.

Categorical variables will be summarized by frequencies and percentages, while quantitative variables will be summarized by descriptive statistics (mean, median, standard deviation, minimum, and maximum).

The investigators will compare taxonomy and phylogeny biodiversity between the control and the IBD arms and between stool and colon effluent samples.

Enrollment: 20 patients

Sex: All

Ages: 18 to 80 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• The patient's age is between 18 and 80 years old
• For study arm - patients with known colonic IBD based on colonoscopic findings - diagnosed with either Ulcerative Colitis or Crohn's Disease scheduled for surveillance colonoscopy.
• For control arm - patients scheduled for routine colonoscopy without active IBD symptoms or IBD diagnosis

Exclusion criteria

• The patient has an underlying condition that in the opinion of the investigator may adversely affect the patient's ability to understand, comply with, or follow protocol instructions
• History of intestinal resection (appendectomy allowed)
• Active Clostridium difficile colitis
• Antibiotic use for 2 months prior to colonoscopy
• The patient has any of the contraindications listed below:

congestive heart failure, intestinal perforation, carcinoma of the rectum, fissures or fistula, severe hemorrhoids, abdominal hernia, renal insufficiency, cirrhosis, pregnancy, or recent colon, rectal, or abdominal surgery

Trial design

Primary purpose: Health Services Research

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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20 participants in 2 patient groups

IBD

Experimental group

Description:

10 patients diagnosed with colonic IBD (5 diagnosed with Ulcerative Colitis and 5 diagnosed with Crohn's Disease) scheduled for a surveillance colonoscopy

Treatment:

Device: Hygieacare System

Control

Active Comparator group

Description:

10 patients scheduled for a routine screening colonoscopy who do not have a history of IBD symptoms or IBD diagnosis

Treatment:

Device: Hygieacare System