Lactobacillus Rhamnosus GG Oral Treatment Efficacy on Vernal Keratoconjunctivitis Treatment

Campus Bio-Medico University48 enrolled

Overview

This interventional study aims to evaluate the efficacy of oral administration of Lactobacillus Rhamnosus GG in preventing relapses of ocular inflammation in Vernal Keratoconjunctivitis (VKC) patients.

Vernal keratoconjunctivitis (VKC) is a chronic allergic disease, characterised by ocular surface inflammation lasting all year with seasonal relapses. Active phases of VKC are characterised by intense ocular symptoms and require treatment with topical steroids to control inflammation and corneal damage. To date, safe and effective therapies in preventing relapses of VKC are not available. Recently, the use of oral administration of probiotics for allergic diseases have been proposed. No data are available on the effects of probiotics on ocular allergies. This multicenter, double-masked, randomised, controlled clinical trial will allow to obtain more data on the efficacy of oral treatment with Lactobacillus Rhamnosus GG in patients affected by VKC. Patients with VKC will be treated with Lactobacillus Rhamnosus GG or placebo in addition to ketotifen fumarate 0.025% eye drops (standard treatment). The number of relapses per year, signs and symptoms of the disease, total symptom score (TSyS), total sign score (TSS), biochemical and molecular parameters will be evaluated at different time points.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

QUADRUPLE

Enrollment

Conditions

Vernal Keratoconjunctivitis

Interventions

Lactobacillus Rhamnosus GGDRUG

patients are treated with oral Lactobacillus Rhamnosus GG once daily for six months

placebo (sugar)DRUG

Placebo will be administered to patients once daily for six months

Eligibility

Sex: ALLMin age: 5 YearsMax age: 16 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Diagnosis of VKC performed on the basis of personal and family history of systemic allergic diseases, clinical examination (presence of conjunctival tarsal and/or limbal papillae) and presence of eosinophils in the conjunctival scraping. Exclusion Criteria: * Contact lens wearers, * Patients affected by other ocular diseases, * Patients subjected to ocular surgery in the preceding 6 months, * Patients under eye drop or systemic treatments for other diseases, * Patients enrolled in experimental trials in the preceding 6 months.

Locations (3)

University of Genova

Genova, Italy

University of Padua

Padua, Italy

University Campus Bio-Medico

Rome, Italy

Outcomes

Primary Outcomes

To evaluate a difference in the number of relapses of ocular inflammation for year between Lactobacillus Rhamnosus GG and placebo treated groups. Relapses will be defined as at least 100% increase of the sum of hyperemia,

Time frame: 2 years

Secondary Outcomes

Differences of specific symptoms and signs, TSyS, TSS, Quick questionnaire subscales,biochemical and molecular parameters will be evaluated at baseline, after 1, 3 and 6 months of treatment and after 1 month of treatment discontinuation

Time frame: 2 years

Data from ClinicalTrials.gov

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