Lactobacillus Rhamnosus GG Oral Treatment Efficacy on Vernal Keratoconjunctivitis Treatment - Full Text View

Purpose

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	Intervention	Phase
Vernal Keratoconjunctivitis	Drug: Lactobacillus Rhamnosus GG Drug: placebo (sugar)	Phase 2 Phase 3

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Crossover Assignment Masking: Double Blind (Subject, Caregiver, 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.

Resource links provided by NLM:

Genetics Home Reference related topics: keratitis-ichthyosis-deafness syndrome

Drug Information available for: Lactobacillus

U.S. FDA Resources

Further study details as provided by Campus Bio-Medico University:

Primary Outcome Measures:

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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

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 ] [ Designated as safety issue: No ]

Estimated Enrollment:	48
Study Start Date:	March 2007
Study Completion Date:	January 2009
Primary Completion Date:	September 2008 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
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

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

Ages Eligible for Study:	5 Years to 16 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00445120

Locations

Italy
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

Investigators

Study Director:

Stefano Bonini, MD

University Campus Bio-Medico

More Information

Publications:

Kalliomaki M, Salminen S, Arvilommi H, Kero P, Koskinen P, Isolauri E. Probiotics in primary prevention of atopic disease: a randomised placebo-controlled trial. Lancet. 2001 Apr 7;357(9262):1076-9.

Kalliomaki M, Salminen S, Poussa T, Arvilommi H, Isolauri E. Probiotics and prevention of atopic disease: 4-year follow-up of a randomised placebo-controlled trial. Lancet. 2003 May 31;361(9372):1869-71.

Boyle RJ, Tang ML. The role of probiotics in the management of allergic disease. Clin Exp Allergy. 2006 May;36(5):568-76. Review.

Peng GC, Hsu CH. The efficacy and safety of heat-killed Lactobacillus paracasei for treatment of perennial allergic rhinitis induced by house-dust mite. Pediatr Allergy Immunol. 2005 Aug;16(5):433-8.

Viljanen M, Savilahti E, Haahtela T, Juntunen-Backman K, Korpela R, Poussa T, Tuure T, Kuitunen M. Probiotics in the treatment of atopic eczema/dermatitis syndrome in infants: a double-blind placebo-controlled trial. Allergy. 2005 Apr;60(4):494-500.

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.

Leonardi A. Vernal keratoconjunctivitis: pathogenesis and treatment. Prog Retin Eye Res. 2002 May;21(3):319-39. Review.

Responsible Party:	Stefano Bonini, University of Rome Campus Bio-Medico
ClinicalTrials.gov Identifier:	NCT00445120 History of Changes
Other Study ID Numbers:	LACTO2, Eudract number 2007-000209-31
Study First Received:	March 7, 2007
Last Updated:	January 28, 2009
Health Authority:	Italy: The Italian Medicines Agency Italy: Ethics Committee

Keywords provided by Campus Bio-Medico University:

Vernal keratoconjunctivitis
probiotic
Lactobacillus Rhamnosus GG
Children
Clinical trial

Additional relevant MeSH terms:

Keratoconjunctivitis
Conjunctivitis, Allergic
Conjunctivitis
Conjunctival Diseases
Eye Diseases

Keratitis
Corneal Diseases
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases

ClinicalTrials.gov processed this record on May 22, 2013