Back to resultsAssessing Uniqueness of Inflammatory Bowel Disease Related Microbiome-derived Biomarkers
Primary Purpose
Irritable Bowel Disease
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Hygieacare System
Sponsored by
About this trial
This is an interventional health services research trial for Irritable Bowel Disease
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
Sites / Locations
- Hygieacare Center
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
IBD
Control
Arm Description
10 patients diagnosed with colonic IBD (5 diagnosed with Ulcerative Colitis and 5 diagnosed with Crohn's Disease) scheduled for a surveillance colonoscopy
10 patients scheduled for a routine screening colonoscopy who do not have a history of IBD symptoms or IBD diagnosis
Outcomes
Primary Outcome Measures
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.
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.
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
Secondary Outcome Measures
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.
Alpha diversity
16S and meta genomics analysis
Shannon index
16S and meta genomics analysis
beta diversity
PCoA analysis
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05640583
Brief Title
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
2. Study Status
Record Verification Date
December 2021
Overall Recruitment Status
Completed
Study Start Date
March 16, 2022 (Actual)
Primary Completion Date
March 6, 2023 (Actual)
Study Completion Date
March 6, 2023 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
HyGIeaCare, Inc.
4. Oversight
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
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Irritable Bowel Disease
7. Study Design
Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
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
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
20 (Actual)
8. Arms, Groups, and Interventions
Arm Title
IBD
Arm Type
Experimental
Arm Description
10 patients diagnosed with colonic IBD (5 diagnosed with Ulcerative Colitis and 5 diagnosed with Crohn's Disease) scheduled for a surveillance colonoscopy
Arm Title
Control
Arm Type
Active Comparator
Arm Description
10 patients scheduled for a routine screening colonoscopy who do not have a history of IBD symptoms or IBD diagnosis
Intervention Type
Device
Intervention Name(s)
Hygieacare System
Intervention Description
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.
Primary Outcome Measure Information:
Title
Detection of IBD-related microbiome-derived biomarkers in stool samples
Description
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.
Time Frame
analysis end of study enrollment
Title
unpaired T-test
Description
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.
Time Frame
analysis end of study enrollment
Title
cox wilcoxon test
Description
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
Time Frame
through study completion, an average of 1 year
Secondary Outcome Measure Information:
Title
Differential abundance analysis
Description
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.
Time Frame
through study completion, an average of 1 year
Title
Alpha diversity
Description
16S and meta genomics analysis
Time Frame
through study completion, an average of 1 year
Title
Shannon index
Description
16S and meta genomics analysis
Time Frame
through study completion, an average of 1 year
Title
beta diversity
Description
PCoA analysis
Time Frame
through study completion, an average of 1 year
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
David A Johnson, MD
Organizational Affiliation
Digestive & Liver Disease Specialists
Official's Role
Principal Investigator
Facility Information:
Facility Name
Hygieacare Center
City
Norfolk
State/Province
Virginia
ZIP/Postal Code
23502
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
IPD Sharing Plan Description
The outcome of the colon effluent analysis will be published.
Learn more about this trial
Assessing Uniqueness of Inflammatory Bowel Disease Related Microbiome-derived Biomarkers
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