Assessing Uniqueness of Inflammatory Bowel Disease Related Microbiome-derived Biomarkers
Completed · Not applicable
Conditions studied: Irritable Bowel Disease
In brief
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Ⓡ).
Key facts
- Study ID
- NCT05640583
- Run by
- HyGIeaCare, Inc.
- People needed
- 20
- Starts
- 2022-03-16
- Expected to finish
- 2023-03-06
- Last updated by the study team
- 2023-04-27
Who can join
Age: 18 and older, up to 80. Sex: any. Healthy volunteers: accepted.
You may qualify if…
- 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
You may not qualify if…
- 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
Where it is running
- Hygieacare Center — Norfolk, Virginia, United States
Full record on ClinicalTrials.gov
Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.