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Completed

NCT Number: NCT05640583

Assessing Uniqueness of Inflammatory Bowel Disease Related Microbiome-derived Biomarkers

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Ⓡ).

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Key information

Conditions

Irritable Bowel Disease Colonic Diseases Colonic Diseases, Functional Digestive System Diseases Gastrointestinal Diseases Intestinal Diseases Irritable Bowel Syndrome

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Hygieacare Center

Norfolk, Virginia, 23502, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Primary outcomes

  1. Detection of IBD-related microbiome-derived biomarkers in stool samples

    Time frame: analysis end of study enrollment

    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.

  2. unpaired T-test

    Time frame: analysis end of study enrollment

    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.

  3. cox wilcoxon test

    Time frame: through study completion, an average of 1 year

    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 outcomes

  1. Differential abundance analysis

    Time frame: through study completion, an average of 1 year

    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.

  2. Alpha diversity

    Time frame: through study completion, an average of 1 year

    16S and meta genomics analysis

  3. Shannon index

    Time frame: through study completion, an average of 1 year

    16S and meta genomics analysis

  4. beta diversity

    Time frame: through study completion, an average of 1 year

    PCoA analysis

Sponsors and collaborators

Lead sponsor

HyGIeaCare, Inc.

Industry

Registry information

Official study 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

Important dates

Study start
2022
Primary completion
2023
Study completion
2023
First posted
Dec 7, 2022
Registry last updated
Apr 27, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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