Clinical Trial: Microbiota and Immune microEnvironment in Pouchitis

Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Interventional



Official Title: Microbiota and Immune microEnvironment in Pouchitis: Randomized Controlled Trial Oral Administration of Lactobacillus Casei DG After Ileostomy Closure in Ileal Pouch Mucos

Brief Summary:

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:

  1. analysis of the intestinal microbiota with High Throughput Sequencing Unit and anaerobes cultures
  2. characterization of innate immunity with TLR, NLR, nicotinic receptors and LPMC analysis
  3. 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.