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Lactobacillus Rhamnosus GG (ATCC 53103) in Mild-moderately Active UC Patients

NCT04102852 · Status: COMPLETED · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 76

Last updated 2022-10-26

No results posted yet for this study

Summary

This study is a randomized double-blind clinical trial that intends to evaluate the efficacy and safety of LGG administration at two different doses, for 1 month, in ulcerative colitis (UC) patients with mild-moderate disease activity in therapy with oral mesalamine. Efficacy of therapy will be evaluated by clinical (Clinical Mayo score, quality of life assessment), endoscopic (Endoscopic Mayo score), histological, biochemical (white cell count, C-reactive protein), and molecular (mucosal colonization of the bacteria, pro- and anti-inflammatory cytokines measurement) parameters. UC patients with mild-moderately active disease despite oral treatment with mesalamine will be assessed at baseline for clinical, endoscopic, histologic inflammatory activity. After a wash-out period of 4 weeks of mesalamine, patients will be randomized to assume a regular (LGG 1.2 × 10\^10 Colony Forming Units (CFU)/day, 2 capsules a day) or a double (LGG 2.4 × 10\^10 CFU/day, 4 capsules a day) dose of LGG for 1 month. At the end of the treatment, clinical, endoscopic, and histologic inflammatory activity will be evaluated and compared to pre-treatment data. Adhesion and molecular effect of LGG will be also evaluated. Safety will be assessed by weekly phone calls and with direct physical examination at the end of the study period.

Conditions

  • Ulcerative Colitis Chronic Mild
  • Ulcerative Colitis Chronic Moderate

Interventions

DIETARY_SUPPLEMENT

Lactobacillus rhamnosus GG ATCC 53103

probiotic administration at two different doses for 1 month

Sponsors & Collaborators

  • Onlus S. Andrea

    collaborator UNKNOWN

  • San Giovanni Addolorata Hospital

    lead OTHER

Principal Investigators

  • Cristiano Pagnini, MD, PhD · S.Giovanni Addolorata Hospital

  • Gianfranco Delle Fave, MD · Onlus S. Andrea

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2019-09-30
Primary Completion
2022-01-31
Completion
2022-01-31

Countries

  • Italy

Study Locations

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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 NCT04102852 on ClinicalTrials.gov