Clinical trial NCT00445120: Lactobacillus Rhamnosus GG Oral Treatment Efficacy on Vernal Keratoconjunctivitis Treatment
Official title: Multicenter, Randomised, Double Masked, Controlled Studies on the Efficacy of Lactobacillus Rhamnosus GG Treatment in Preventing Vernal Keratoconjunctivitis VKC) Relapses.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
PHASE3
Conditions: Vernal Keratoconjunctivitis
Keywords: Vernal keratoconjunctivitis
probiotic
Lactobacillus Rhamnosus GG
Children
Clinical trial
Lead sponsor: Campus Bio-Medico University
Sponsor class: OTHER
Collaborators: name: University of Genova
name: University of Padova
First posted: 2007-03-08
Enrollment: 48
Sex: ALL
Minimum age (years): 5
Maximum age (years): 16
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: PREVENTION

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.

Eligibility criteria: 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.

Primary outcomes:
measure: 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,
timeFrame: 2 years
Secondary outcomes:
measure: 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
timeFrame: 2 years
Other outcomes:
Locations:
city: Genova
country: Italy
facility: University of Genova
city: Padua
country: Italy
facility: University of Padua
city: Rome
country: Italy
facility: University Campus Bio-Medico
Study officials:
affiliation: University Campus Bio-Medico
name: Stefano Bonini, MD
role: STUDY_DIRECTOR
References:
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citation: Bonini S, Bonini S, Lambiase A, Marchi S, Pasqualetti P, Zuccaro O, Rama P, Magrini L, Juhas T, Bucci MG. Vernal keratoconjunctivitis revisited: a case series of 195 patients with long-term followup. Ophthalmology. 2000 Jun;107(6):1157-63. doi: 10.1016/s0161-6420(00)00092-0.
citation: Leonardi A. Vernal keratoconjunctivitis: pathogenesis and treatment. Prog Retin Eye Res. 2002 May;21(3):319-39. doi: 10.1016/s1350-9462(02)00006-x.