The MIC trial: Microbiota and immune cells in IBD.

In depth characterization of the mucosal microbiota in patients with IBD using novel, potent high-throughput approaches and their interaction with the immune system.

Status

Recruiting

Phases

Unknown

Study type

Observational

Source

NL-OMON

Registry ID

NL-OMON21068

Enrollment

Registered

2011-05-20

Start date

2011-03-15

Completion date

Unknown

Last updated

2024-02-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

microbiota and immune cells in IBD

Interventions

None listed

Eligibility

Inclusion criteria

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; 3. Patients with active left-sided ulcerative colitis or Crohn’s colitis who are scheduled for diverting ostomy.

Exclusion criteria

Exclusion criteria: 1. Ischemia of the bowel; 2. Positive stool cultures or parasite tests for common enteric pathogens; 3. Use of Antibiotics in preceding 4 weeks; 4. Use of probiotics in preceding 8 weeks; 5. Radiation therapy within 4 weeks before surgery; 6. Chemotherapy within 4 weeks before surgery.

Design outcomes

Primary

Measure	Time frame
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; 2. Intra-individual differences in presence of microbial DNA in specific microenvironmental spaces of sigmoid mucosa before and 12 weeks after diverting ostomy; 3. Identify adaptive and innate immune cells producing cytokines involved in IBD.	—

Measure

Time frame

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; 2. Intra-individual differences in presence of microbial DNA in specific microenvironmental spaces of sigmoid mucosa before and 12 weeks after diverting ostomy; 3. Identify adaptive and innate immune cells producing cytokines involved in IBD.

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Secondary

Measure	Time frame
1. Presence of microbial DNA in granuloma’s of CD patients; 2. Assessment of co-localisation between invading microbes and lamina propria macrophages dendritic cells using FISH probes; 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; 4. Assessment of signalling between innate lymfoid cell (ILC) subsets and lamina propria macrophages dendritic cells; 5. Assessment of ILC’s subpopulations in peripheral blood.	—

Measure

Time frame

1. Presence of microbial DNA in granuloma’s of CD patients; 2. Assessment of co-localisation between invading microbes and lamina propria macrophages dendritic cells using FISH probes; 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; 4. Assessment of signalling between innate lymfoid cell (ILC) subsets and lamina propria macrophages dendritic cells; 5. Assessment of ILC’s subpopulations in peripheral blood.

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Contacts

Public ContactN.G.M. Rossen

Dept. Gastroenterology & Hepatology Academic Medical Center Amsterdam Meibergdreef 9, C2-231

N.G.Rossen@amc.uva.nl+31 (0)20 5662199

Outcome results