Assessing Uniqueness of Inflammatory Bowel Disease Related Microbiome-derived Biomarkers
Launched by HYGIEACARE, INC. · Nov 28, 2022
Trial Information
Current as of January 13, 2025
Completed
Keywords
ClinConnect Summary
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 deviati...
Gender
ALL
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
Trial Officials
David A Johnson, MD
Principal Investigator
Digestive & Liver Disease Specialists
About Hygieacare, Inc.
Hygieacare, Inc. is a pioneering clinical trial sponsor dedicated to advancing healthcare solutions through innovative research and development. Focused on enhancing patient outcomes and safety, the company specializes in the development of novel medical devices and therapeutic interventions. With a commitment to rigorous scientific standards and regulatory compliance, Hygieacare aims to bridge the gap between cutting-edge technology and clinical practice, fostering collaboration with healthcare professionals and research institutions. Through its comprehensive clinical trial programs, Hygieacare seeks to contribute significantly to the evolution of medical treatments and improve the quality of care for patients worldwide.
Contacts
Jennifer Cobb
Immunology at National Institute of Allergy and Infectious Diseases (NIAID)
Locations
Norfolk, Virginia, United States
People applied
Timeline
First submit
Trial launched
Trial updated
Estimated completion
Not reported
Discussion 0
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