At a glance
ClinicalIndex Comparison RecordPhase 3Completed· 48 target
Drug / intervention
Lactobacillus Rhamnosus GG +1 moredrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
Multicenter, Randomised, Double Masked, Controlled Studies on the Efficacy of Lactobacillus Rhamnosus GG Treatment in Preventing Vernal Keratoconjunctivitis VKC) Relapses.
In Brief
A Phase 3 clinical trial evaluating Lactobacillus Rhamnosus GG and placebo (sugar) for Vernal Keratoconjunctivitis. Completed, enrolled 48 participants across 3 sites.
Detailed 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.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsVernal Keratoconjunctivitis
CountriesItaly
CollaboratorsUniversity of Genova, University of Padova
Timeline
Phase 3CompletedFinished
200720082009201020112012201320142015201620172018201920202021202220232024202520262027
Enrollment StartMar 2007
First PostedMar 2007
Primary CompletionSep 2008
Study CompletionJan 2009
TodayJul 2026
First PostedMar 8, 2007
Enrollment StartMar 1, 2007
Primary CompletionSep 1, 2008
Study CompletionJan 1, 2009
TodayJul 2, 2026
Enrollment to primary: 1.5 yearsPosted 19.3 years ago
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