Microbiota and Immune microEnvironment in Pouchitis

• Register: ClinicalTrials.gov
• Last refreshed on: 16 December 2017
• Main ID: NCT03136419
• Date of registration: 05/04/2017
• Prospective Registration: No
• Primary sponsor: University of Padova
• Public title: Microbiota and Immune microEnvironment in Pouchitis MEP1
• Scientific title: Microbiota and Immune microEnvironment in Pouchitis: Randomized Controlled Trial Oral Administration of Lactobacillus Casei DG After Ileostomy Closure in Ileal Pouch Mucosa
• Date of first enrolment: October 31, 2016
• Target sample size: 32
• Recruitment status: Recruiting
• URL: https://clinicaltrials.gov/show/NCT03136419
• Study type: Interventional
• Study design: Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Prevention. Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor).
• Phase: N/A

Countries of recruitment

Italy

Contacts

• Name: Marco Scarpa, MD

• Name: Imerio Angriman, MD
• Affiliation: University of Padova

• Name: Imerio Angriman, MD

Key inclusion & exclusion criteria

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.



Age minimum: 18 Years
Age maximum: 100 Years
Gender: All

Health Condition(s) or Problem(s) studied

Pouchitis

Ileal Pouch

Ulcerative Colitis

Intervention(s)

Dietary Supplement: Placebo

Dietary Supplement: Lactobacillus casei DG

Primary Outcome(s)

quantification of inflammatory cytokines in the ileal mucosa levels by Bio-Plex cytokine immunoassay [Time Frame: 8 weeks]

Secondary Outcome(s)

Relative abundance of bacterial phyla in faecal specimens [Time Frame: 8 weeks]

Systemic and local inflammatory status [Time Frame: 12 months]

analysis of TLRs network [Time Frame: 8 weeks]

Histological inflammatory severity [Time Frame: 8 weeks]

activation status of macrophages, dendritic cells, infiltrating lymphocytes [Time Frame: 8 weeks]

pouchitis episodes [Time Frame: 12 months]

quantify epithelial and leucocytes-derived anti-microbial defensins [Time Frame: 8 weeks]

Secondary ID(s)

MEP1

Source(s) of Monetary Support

Please refer to primary and secondary sponsors