Clinical Trials Logo
  1. Home
  2. Vernal Keratoconjunctivitis
  3. NCT00445120

Lactobacillus Rhamnosus GG Oral Treatment Efficacy on Vernal Keratoconjunctivitis Treatment

Vernal Keratoconjunctivitis Clinical Trial

Official title:
Multicenter, Randomised, Double Masked, Controlled Studies on the Efficacy of Lactobacillus Rhamnosus GG Treatment in Preventing Vernal Keratoconjunctivitis VKC) Relapses.

Clinical Trial 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.

Clinical Trial 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 Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Prevention

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT00445120
Study type Interventional
Source Campus Bio-Medico University
Contact
Status Completed
Phase Phase 2/Phase 3
Start date March 2007
Completion date January 2009
View Details
See also
  Status Clinical Trial Phase
Completed NCT05076084 - Evaluation of the Efficacy and Safety of Tacrolimus Drops in Children With Vernal Keratoconjunctivitis
Recruiting NCT02057822 - Cytokine Assay in Tears of Healthy Children and With Vernal Keratoconjunctivitis: Case Control Study and Monitoring of Cases at 6 Months N/A
Completed NCT03464435 - A Novel Combined Therapy for Refractory Vernal Keratoconjunctivitis Phase 4
Recruiting NCT03557203 - Dermatologic Tacrolimus Ointment on Eyelids in the Treatment of Refractory Vernal Keratoconjunctivitis and Atopic Keratoconjunctivitis
Completed NCT01211327 - Topical Cyclosporine for Vernal Keratoconjunctivitis (VKC) in Rwanda Phase 4
Completed NCT05353101 - Cyclosporine 0.05% Eye Drops for Vernal Keratoconjunctivitis Trial Phase 1
Not yet recruiting NCT04705584 - Topical Immuonosuppressant Drugs in Spring Catarrh N/A
Completed NCT03379311 - A Study of AK002 in Patients With Atopic Keratoconjunctivitis, Vernal Keratoconjunctivitis, and Perennial Allergic Conjunctivitis Phase 1
Completed NCT00426023 - Cyclosporin A Eye Drop Treatment in Vernal Keratoconjunctivitis Phase 3
Completed NCT01751126 - Double-Masked Trial of NOVA22007 (1mg/mL Ciclosporin/Cyclosporine) Versus Vehicle in Pediatric Patients With Active Severe Vernal Keratoconjunctivitis Phase 3
Recruiting NCT02456025 - Topical Tacrolimus in Vernal Keratoconjunctivitis Phase 4