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NCT05640583
Assessing Uniqueness of Inflammatory Bowel Disease Related Microbiome-derived Biomarkers
Conditions: Irritable Bowel Disease
Sex: All
Ages: 18 Years – 80 Years
Healthy volunteers: 1
Phase: NA
Enrollment: 20
Sponsor: HyGIeaCare, Inc.
Location: United States
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Ⓡ).
Eligibility Criteria
Inclusion Criteria:The patient's age is between 18 and 80 years oldFor 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 diagnosisExclusion 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 instructionsHistory of intestinal resection (appendectomy allowed)Active Clostridium difficile colitisAntibiotic use for 2 months prior to colonoscopyThe 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
Source: ClinicalTrials.gov (NCT05640583). StuddyBuddy aggregates publicly available trial information.