Assessing Uniqueness of Inflammatory Bowel Disease Related Microbiome-derived Biomarkers

NCT05640583 | Completed FDA Device

• 1 other identifier: HGP-0011
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief 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

Outcome Measures

Primary Outcomes (3)

• 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 Outcomes (4)

• Differential abundance analysis

  through study completion, an average of 1 year

• Alpha diversity

  through study completion, an average of 1 year

• Shannon index

  through study completion, an average of 1 year

• beta diversity

  through study completion, an average of 1 year

Study Arms (2)

IBD

EXPERIMENTAL

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

Control

ACTIVE COMPARATOR

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

Device: Hygieacare System

Interventions

Hygieacare System DEVICE

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.

Control; IBD

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• HyGIeaCare, Inc.: lead

Study Sites (1)

Hygieacare Center

Norfolk, Virginia, 23502, United States

Location

MeSH Terms

Conditions

Irritable Bowel Syndrome

Condition Hierarchy (Ancestors)

Colonic Diseases, Functional; Colonic Diseases; Intestinal Diseases; Gastrointestinal Diseases; Digestive System Diseases

Study Officials

• David A Johnson, MD

  Digestive & Liver Disease Specialists

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Study Arm = 10 patients diagnosed with colonic IBD (5 diagnosed with Ulcerative Colitis and 5 diagnosed with Crohn's Disease) scheduled for a surveillance colonoscopy Control Arm = 10 patients scheduled for a routine screening colonoscopy who do not have a history of IBD symptoms or IBD diagnosis

Study Record Dates

• First Submitted: December 18, 2021
• First Posted: December 7, 2022
• Study Start: March 16, 2022
• Primary Completion: March 6, 2023
• Study Completion: March 6, 2023
• Last Updated: April 27, 2023

Record last verified: 2021-12

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)