NCT05640583

Assessing Uniqueness of Inflammatory Bowel Disease Related Microbiome-derived Biomarkers

Assessing the Uniqueness of Inflammatory Bowel Disease Related Microbiome-derived Biomarkers Found in the Lumen of the Human Large Intestine in Comparison to Those Found in Spontaneously Excreted Stool Samples

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 20 (actual)
• Sponsor: HyGIeaCare, Inc. · Industry
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Accepted

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Ⓡ).

Detailed 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.

Conditions

• Irritable Bowel Disease

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2022-03-16
• Primary completion: 2023-03-06
• Completion: 2023-03-06
• First posted: 2022-12-07
• Last updated: 2023-04-27

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study