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PRObiotic VSL#3® for Maintenance of Clinical and Endoscopic REMission in Ulcerative Colitis

NCT03415711 · Status: TERMINATED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 14

Last updated 2020-01-18

No results posted yet for this study

Summary

Ulcerative colitis (UC) is an inflammatory bowel disease (IBD) characterized by chronic inflammation limited to colonic mucosa. Its pathogenesis is not still clear, even if a multifactorial aetiology has been advocated. The aim of this study is to evaluate the long-term efficacy of two different doses of VSL#3® added on standard therapy (5-ASA) in maintaining remission in an adult population of patients with UC, compared with the standard therapy (5-ASA) plus placebo. The investigators hypothesized that adding VSL#3® to mesalamine would lead to higher remission rate at long-term evaluation.

Conditions

Interventions

DIETARY_SUPPLEMENT

VSL#3®

VSL#3® 450 billion sachets

DRUG

Mesalamine

Mesalamine 2.4 g/day in once daily administration.

DRUG

Placebo

sachets with maltose, cornstarch and dioxide

Sponsors & Collaborators

  • Actial Farmaceutica S.r.l.

    collaborator INDUSTRY

  • VSL Pharmaceuticals

    lead INDUSTRY

Principal Investigators

  • Alessandro Armuzzi · Policlinico Universitario Agostino Gemelli Università Cattolica del Sacro Cuore

Study Design

Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
85 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2017-04-28
Primary Completion
2019-04-24
Completion
2019-04-24

Countries

  • Italy

Study Locations

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Entities

Drugs
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 NCT03415711 on ClinicalTrials.gov