Assessing Uniqueness of Inflammatory Bowel Disease Related Microbiome-derived Biomarkers

Irritable Bowel Disease Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05640583
• Other study ID #: HGP-0011
• Status: Completed
• Phase: N/A
• Start date: March 16, 2022
• Est. completion date: March 6, 2023

Study information

• Verified date: December 2021
• Source: HyGIeaCare, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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Ⓡ).

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20
• Est. completion date: March 6, 2023
• Est. primary completion date: March 6, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Inflammatory Bowel Diseases
• Intestinal Diseases
• Irritable Bowel Disease
• Irritable Bowel Syndrome

Intervention

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.

Locations

Country	Name	City	State
United States	Hygieacare Center	Norfolk	Virginia

Sponsors (1)

Lead Sponsor	Collaborator
HyGIeaCare, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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	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
Secondary	Alpha diversity	16S and meta genomics analysis	through study completion, an average of 1 year
Secondary	Shannon index	16S and meta genomics analysis	through study completion, an average of 1 year
Secondary	beta diversity	PCoA analysis	through study completion, an average of 1 year