Lactobacillus Rhamnosus GG Oral Treatment Efficacy on Vernal Keratoconjunctivitis Treatment

Phase 2

Completed

• Conditions: Vernal Keratoconjunctivitis
• Interventions: Drug: Lactobacillus Rhamnosus GG; Drug: placebo (sugar)

• Registration Number: NCT00445120
• Lead Sponsor: Campus Bio-Medico University

Brief Summary

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.

Detailed Description

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 Timeline

• Study Start: 2007-03
• Study First Submitted: 2007-03-07
• Study First Submitted QC: 2007-03-07
• Study First Posted: 2007-03-08
• Primary Completion: 2008-09
• Status Verified: 2009-01
• Study Completion: 2009-01
• Last Update Submitted: 2009-01-28
• Last Update Posted: 2009-01-29

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 48

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
1	Lactobacillus Rhamnosus GG	-
2	placebo (sugar)	-

Primary Outcome Measures

Name	Time	Method
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,	2 years

Secondary Outcome Measures

Name	Time	Method
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	2 years

Trial Locations

Locations (3)

University of Padua; 🇮🇹 Padua, Italy

University of Genova; 🇮🇹 Genova, Italy

University Campus Bio-Medico; 🇮🇹 Rome, Italy