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Microbiota and Immune microEnvironment in Pouchitis

NCT03136419 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 32

Last updated 2017-05-02

No results posted yet for this study

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.

Conditions

Interventions

DIETARY_SUPPLEMENT

Lactobacillus casei DG

Lactobacillus casei DG probiotic supplementation for 8 weeks

DIETARY_SUPPLEMENT

Placebo

Placebo supplementation for 8 weeks

Sponsors & Collaborators

  • University of Padova

    lead OTHER

Principal Investigators

  • Imerio Angriman, MD · University of Padova

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
100 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2016-10-31
Primary Completion
2018-10-31
Completion
2019-04-30

Countries

  • Italy

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03136419 on ClinicalTrials.gov