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

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Ⓡ).

Study Overview

• Status: Completed
• Conditions: Irritable Bowel Disease
• Intervention / Treatment: Device: Hygieacare System

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.

• Study Type: Interventional
• Enrollment (Actual): 20
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Virginia
    • Norfolk, Virginia, United States, 23502
      • HyGIeaCare Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Health Services Research
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: IBD; 10 patients diagnosed with colonic IBD (5 diagnosed with Ulcerative Colitis and 5 diagnosed with Crohn's Disease) scheduled for a surveillance colonoscopy	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.
Active Comparator: Control; 10 patients scheduled for a routine screening colonoscopy who do not have a history of IBD symptoms or IBD diagnosis	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Detection of IBD-related microbiome-derived biomarkers in stool samples	Each patient provides both stool (when possible) and inner-colonic samples. The samples will be analyzed to identify microorganisms' presence and abundance, diversity, and functional genomics. Specifically, we will look at the alpha and beta diversity of the microbiota (% of prediction on the most dominant vectors of the system) and the taxonomic differences between the samples - represented by percentages over taxonomic groups. If the data allows (based on our omics results), we will look at the potential abundance of calprotectin (IBD biomarker, % from control). We will analyze the data for the study participants by age, gender, BMI (average, median, standard deviation), and prevalence of underlying diseases. The questionnaires will be used to find correlations between the patient's overall health, exercise routine, nutritional habits, and diet. Results will be presented using R^2 when applies.	analysis end of study enrollment
unpaired T-test	We will track the patients demographic and physiological parameters - age (years), gender (male/female), height (feet inches), weight (lbs), BMI. We will collect information about the patients eating, heath, and exercise habits using a questionnaire.	analysis end of study enrollment
cox wilcoxon test	We will track the patients demographic and physiological parameters - age (years), gender (male/female), height (feet inches), weight (lbs), BMI. We will collect information about the patients eating, heath, and exercise habits using a questionnaire	through study completion, an average of 1 year

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Differential abundance analysis	For our comparative analyses, we will carry out clustering and differential abundance. we will qualify the bacteria abundance using 16S and meta genomics analysis and provide information of the available species using Alpha diversity and Shannon index and beta diversity using PCoA analysis. analysis with correction for multiple comparisons by false discovery rate.	through study completion, an average of 1 year
Alpha diversity	16S and meta genomics analysis	through study completion, an average of 1 year
Shannon index	16S and meta genomics analysis	through study completion, an average of 1 year
beta diversity	PCoA analysis	through study completion, an average of 1 year

Collaborators and Investigators

• Sponsor: HyGIeaCare, Inc.

Study record dates

Study Major Dates

• Study Start (Actual): March 16, 2022
• Primary Completion (Actual): March 6, 2023
• Study Completion (Actual): March 6, 2023

Study Registration Dates

• First Submitted: December 18, 2021
• First Submitted That Met QC Criteria: November 28, 2022
• First Posted (Actual): December 7, 2022

Study Record Updates

• Last Update Posted (Actual): April 27, 2023
• Last Update Submitted That Met QC Criteria: April 26, 2023
• Last Verified: December 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Digestive System Diseases; Gastrointestinal Diseases; Gastroenteritis; Colonic Diseases, Functional; Colonic Diseases; Irritable Bowel Syndrome; Inflammatory Bowel Diseases; Intestinal Diseases
• Other Study ID Numbers: HGP-0011

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: The outcome of the colon effluent analysis will be published.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: No