Lactobacillus Rhamnosus GG Oral Treatment Efficacy on Vernal Keratoconjunctivitis Treatment

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00445120
Recruitment Status : Completed
First Posted : March 8, 2007
Last Update Posted : January 29, 2009
University of Genova
University of Padova
Information provided by:
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.

Condition or disease Intervention/treatment Phase
Vernal Keratoconjunctivitis Drug: Lactobacillus Rhamnosus GG Drug: placebo (sugar) Phase 2 Phase 3

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 Type : Interventional  (Clinical Trial)
Estimated Enrollment : 48 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Multicenter, Randomised, Double Masked, Controlled Studies on the Efficacy of Lactobacillus Rhamnosus GG Treatment in Preventing Vernal Keratoconjunctivitis VKC) Relapses.
Study Start Date : March 2007
Actual Primary Completion Date : September 2008
Actual Study Completion Date : January 2009

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Experimental: 1 Drug: Lactobacillus Rhamnosus GG
patients are treated with oral Lactobacillus Rhamnosus GG once daily for six months

Placebo Comparator: 2 Drug: placebo (sugar)
Placebo will be administered to patients once daily for six months

Primary Outcome Measures :
  1. 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 Outcome Measures :
  1. 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 ]

Information from the National Library of Medicine

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Ages Eligible for Study:   5 Years to 16 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00445120

University of Genova
Genova, Italy
University of Padua
Padua, Italy
University Campus Bio-Medico
Rome, Italy, 00155
Sponsors and Collaborators
Campus Bio-Medico University
University of Genova
University of Padova
Study Director: Stefano Bonini, MD University Campus Bio-Medico

Responsible Party: Stefano Bonini, University of Rome Campus Bio-Medico Identifier: NCT00445120     History of Changes
Other Study ID Numbers: LACTO2
Eudract number 2007-000209-31
First Posted: March 8, 2007    Key Record Dates
Last Update Posted: January 29, 2009
Last Verified: January 2009

Keywords provided by Campus Bio-Medico University:
Vernal keratoconjunctivitis
Lactobacillus Rhamnosus GG
Clinical trial

Additional relevant MeSH terms:
Conjunctivitis, Allergic
Conjunctival Diseases
Eye Diseases
Corneal Diseases
Hypersensitivity, Immediate
Immune System Diseases