The MIC trial: Microbiota and immune cells in IBD.
Recruiting
- Conditions
- microbiota and immune cells in IBD
- Registration Number
- NL-OMON21068
- Lead Sponsor
- Academic Medical Center (AMC)
- Brief Summary
/A
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- Not specified
- Target Recruitment
- 88
Inclusion Criteria
1. Patients ≥18 years or older;
2. Established Crohn’s disease, ulcerative colitis and CRC patients not known with IBD who undergo intestinal resection;
Exclusion Criteria
1. Ischemia of the bowel;
2. Positive stool cultures or parasite tests for common enteric pathogens;
Study & Design
- Study Type
- Observational non invasive
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 1. Intra-individual differences between inflamed and non-inflamed tissue in presence of microbial DNA in specific microenvironmental spaces; differences between IBD patients and controls;<br /><br>2. Intra-individual differences in presence of microbial DNA in specific microenvironmental spaces of sigmoid mucosa before and 12 weeks after diverting ostomy;<br /><br>3. Identify adaptive and innate immune cells producing cytokines involved in IBD.
- Secondary Outcome Measures
Name Time Method 1. Presence of microbial DNA in granuloma’s of CD patients;<br /><br>2. Assessment of co-localisation between invading microbes and lamina propria macrophages dendritic cells using FISH probes;<br /><br>3. Alterations between inflamed and non-inflamed tissue between patients and controls of phagosome maturation and autophagy, as well as apoptosis of mucosal macrophages and dendritic cells in IBD;<br /><br>4. Assessment of signalling between innate lymfoid cell (ILC) subsets and lamina propria macrophages dendritic cells;<br /><br>5. Assessment of ILC’s subpopulations in peripheral blood.