Clinical trial NCT05640583: Assessing Uniqueness of Inflammatory Bowel Disease Related Microbiome-derived Biomarkers
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Irritable Bowel Disease
Lead sponsor: HyGIeaCare, Inc.
Sponsor class: INDUSTRY
First posted: 2022-12-07
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Intervention model description: 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
Primary purpose: HEALTH_SERVICES_RESEARCH

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Ⓡ).

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.

Eligibility criteria: 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

Primary outcomes:
measure: Detection of IBD-related microbiome-derived biomarkers in stool samples
timeFrame: analysis end of study enrollment
measure: unpaired T-test
timeFrame: analysis end of study enrollment
measure: cox wilcoxon test
timeFrame: through study completion, an average of 1 year
Secondary outcomes:
measure: Differential abundance analysis
timeFrame: through study completion, an average of 1 year
measure: Alpha diversity
timeFrame: through study completion, an average of 1 year
measure: Shannon index
timeFrame: through study completion, an average of 1 year
measure: beta diversity
timeFrame: through study completion, an average of 1 year
Other outcomes:
Locations:
city: Norfolk
country: United States
facility: Hygieacare Center
state: Virginia
Study officials:
affiliation: Digestive & Liver Disease Specialists
name: David A Johnson, MD
role: PRINCIPAL_INVESTIGATOR
References: