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Ⓡ).
Accepts Healthy Volunteers
Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms
An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.
An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes.
Searching Both is inclusive of interventional and observational studies.
|Eligible Ages||18 Years - 80 Years|
This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.
Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans.
Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data.
Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs.
Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.
The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.
The person who is responsible for the scientific and technical direction of the entire clinical study.
|David A Johnson, MD|
|Principal Investigator Affiliation||Digestive & Liver Disease Specialists|
Category of organization(s) involved as sponsor (and collaborator) supporting the trial.
The disease, disorder, syndrome, illness, or injury that is being studied.
|Irritable Bowel Disease|
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.
10 patients diagnosed with colonic IBD (5 diagnosed with Ulcerative Colitis and 5 diagnosed with Crohn's Disease) scheduled for a surveillance colonoscopy
Active Comparator: Control
10 patients scheduled for a routine screening colonoscopy who do not have a history of IBD symptoms or IBD diagnosis
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.
If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.
Norfolk, Virginia, 23502
Nichole Canales, LPN