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Microbiota and Immune microEnvironment in Pouchitis (MEP1)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. 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
Information provided by (Responsible Party):
Imerio Angriman, University of Padova

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.

Condition or disease Intervention/treatment Phase
Pouchitis Ulcerative Colitis Ileal Pouch Dietary Supplement: Lactobacillus casei DG Dietary Supplement: Placebo Not Applicable

  Show Detailed Description

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 32 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
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

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Placebo Comparator: Control
Placebo capsules bis in die for 8 weeks
Dietary Supplement: Placebo
Placebo supplementation for 8 weeks

Experimental: Experimental
Lactobacillus casei DG capsules bis in die for 8 weeks
Dietary Supplement: Lactobacillus casei DG
Lactobacillus casei DG probiotic supplementation for 8 weeks

Primary Outcome Measures :
  1. quantification of inflammatory cytokines in the ileal mucosa levels by Bio-Plex cytokine immunoassay [ Time Frame: 8 weeks ]
    IL-1ß, IL-6, TNF-alpha

Secondary Outcome Measures :
  1. quantify epithelial and leucocytes-derived anti-microbial defensins [ Time Frame: 8 weeks ]
    Def2, Def3; DEFA5; DEFA6 by quantitative RT-PCR

  2. pouchitis episodes [ Time Frame: 12 months ]
    pouchitis episodes evaluated at PDAI >5

  3. 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.

  4. 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

  5. Histological inflammatory severity [ Time Frame: 8 weeks ]
    Floren score

  6. 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.

  7. analysis of TLRs network [ Time Frame: 8 weeks ]
    quantitative RT-PCR and immunohistochemistry

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 100 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

All patients with UC who will undergo restorative proctocolectomy with ileal pouch anal anastomosis and that will attend our outpatient's clinic for routine endoscopic and clinical follow-up.

Exclusion Criteria:

Patients with cuffitis (inflammation of the rectal mucosa remnant) or Crohn's disease of the pouch (with perianal fistulae or with inflammation of the afferent ileal limb), as well as patients who will have received antibiotic or probiotic therapy during the previous 30 days will be excluded from the study.

Information from the National Library of Medicine

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 identifier (NCT number): NCT03136419

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Contact: Marco Scarpa, MD 0039 3477245237

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Imerio Angriman Recruiting
Padova, PD, Italy, 35128
Contact: Imerio Angriman, MD    0039337262931   
Sub-Investigator: Ignazio Castagliuolo, MD         
Sub-Investigator: Marco Scarpa, MD         
Sub-Investigator: Renata D'Incà, MD         
Sub-Investigator: Romeo Bardini, MD         
Sponsors and Collaborators
University of Padova
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Principal Investigator: Imerio Angriman, MD University of Padova

Publications of Results:

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Responsible Party: Imerio Angriman, Assistant Professor, University of Padova Identifier: NCT03136419     History of Changes
Other Study ID Numbers: MEP1
First Posted: May 2, 2017    Key Record Dates
Last Update Posted: May 2, 2017
Last Verified: April 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Imerio Angriman, University of Padova:
innate immunity

Additional relevant MeSH terms:
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Colitis, Ulcerative
Gastrointestinal Diseases
Digestive System Diseases
Inflammatory Bowel Diseases
Colonic Diseases
Intestinal Diseases
Ileal Diseases