Microbiota and Immune microEnvironment in Pouchitis (MEP1)
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|ClinicalTrials.gov Identifier: NCT03136419|
Recruitment Status : Unknown
Verified April 2017 by Imerio Angriman, University of Padova.
Recruitment status was: Recruiting
First Posted : May 2, 2017
Last Update Posted : May 2, 2017
Microbiota and innate immunity in pouchitis: predisposing factors and modulation of the inflammation with probiotics.
Around 20-25% of ulcerative colitis patients undergo restorative proctocolectomy with ileal pouch anal anastomosis. Pouchitis is an idiopathic inflammatory disease that may occur in ileal pouches. In our recent studies, we showed altered microbiota and innate immunity relationships in pouchitis. We plain to perform a double-blind, placebo-controlled trial probiotic therapy vs placebo starting at the time of ileostomy closure to evaluate the impact of microbiota that colonizes the pouch mucosa in the pathogenesis of pouchits, to determine how expression and activation status of the innate immunity system in different cell types and anatomical districts of pouch mucosa relate to microbiota population and follow-up the clinical outcome of anal pouches in light of microbiota-innate immune system interplay.
Our study will include three phases:
- analysis of the intestinal microbiota with High Throughput Sequencing Unit and anaerobes cultures
- characterization of innate immunity with TLR, NLR, nicotinic receptors and LPMC analysis
- assessment of microbiota and innate immune system in the ileal pouch before ileostomy closure, 2 months after ileostomy closure and after 1 year follow up.
|Condition or disease||Intervention/treatment||Phase|
|Pouchitis Ulcerative Colitis Ileal Pouch||Dietary Supplement: Lactobacillus casei DG Dietary Supplement: Placebo||Not Applicable|
Show Detailed Description
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||32 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|
|Official Title:||Microbiota and Immune microEnvironment in Pouchitis: Randomized Controlled Trial Oral Administration of Lactobacillus Casei DG After Ileostomy Closure in Ileal Pouch Mucosa|
|Actual Study Start Date :||October 31, 2016|
|Estimated Primary Completion Date :||October 31, 2018|
|Estimated Study Completion Date :||April 30, 2019|
Placebo Comparator: Control
Placebo capsules bis in die for 8 weeks
Dietary Supplement: Placebo
Placebo supplementation for 8 weeks
Lactobacillus casei DG capsules bis in die for 8 weeks
Dietary Supplement: Lactobacillus casei DG
Lactobacillus casei DG probiotic supplementation for 8 weeks
- quantification of inflammatory cytokines in the ileal mucosa levels by Bio-Plex cytokine immunoassay [ Time Frame: 8 weeks ]IL-1ß, IL-6, TNF-alpha
- quantify epithelial and leucocytes-derived anti-microbial defensins [ Time Frame: 8 weeks ]Def2, Def3; DEFA5; DEFA6 by quantitative RT-PCR
- pouchitis episodes [ Time Frame: 12 months ]pouchitis episodes evaluated at PDAI >5
- Relative abundance of bacterial phyla in faecal specimens [ Time Frame: 8 weeks ]Relative abundance of bacterial phyla in faecal specimens will be estimated by sequencing the PCR amplicons targeting 16S rRNA gene for the DNA samples extracted from each faecal specimen.
- Systemic and local inflammatory status [ Time Frame: 12 months ]Systemic and local inflammatory state will be assessed at each experimental timeline by: erythrocyte sedimentation rate (ESR), white blood cell count (WBC), platelets blood count (PLT), CRP and fecal lactoferrin
- Histological inflammatory severity [ Time Frame: 8 weeks ]Floren score
- activation status of macrophages, dendritic cells, infiltrating lymphocytes [ Time Frame: 8 weeks ]assessment of activation status of macrophages, dendritic cells, infiltratinglymphocytes evaluating surface markers (i.e.) and intracellular cytokines pattern (i.e. TNF , IFN , IL4, IL10) by cytofluorimetric analysis.
- analysis of TLRs network [ Time Frame: 8 weeks ]quantitative RT-PCR and immunohistochemistry
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03136419
|Contact: Marco Scarpa, MD||0039 firstname.lastname@example.org|
|Padova, PD, Italy, 35128|
|Contact: Imerio Angriman, MD 0039337262931 email@example.com|
|Sub-Investigator: Ignazio Castagliuolo, MD|
|Sub-Investigator: Marco Scarpa, MD|
|Sub-Investigator: Renata D'Incà, MD|
|Sub-Investigator: Romeo Bardini, MD|
|Principal Investigator:||Imerio Angriman, MD||University of Padova|