- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00445120
Lactobacillus Rhamnosus GG Oral Treatment Efficacy on Vernal Keratoconjunctivitis Treatment
January 28, 2009 updated by: Campus Bio-Medico University
Multicenter, Randomised, Double Masked, Controlled Studies on the Efficacy of Lactobacillus Rhamnosus GG Treatment in Preventing Vernal Keratoconjunctivitis VKC) Relapses.
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 Overview
Status
Completed
Conditions
Intervention / Treatment
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
Enrollment (Anticipated)
48
Phase
- Phase 2
- Phase 3
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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-
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Genova, Italy
- University of Genova
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Padua, Italy
- University of Padua
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Rome, Italy, 00155
- University Campus Bio-Medico
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
5 years to 16 years (Child)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Crossover Assignment
- Masking: Quadruple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: 1
|
patients are treated with oral Lactobacillus Rhamnosus GG once daily for six months
|
Placebo Comparator: 2
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Placebo will be administered to patients once daily for six months
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
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
|
2 years
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
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
|
2 years
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Study Director: Stefano Bonini, MD, University Campus Bio-Medico
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General 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. doi: 10.1016/S0140-6736(00)04259-8.
- 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. doi: 10.1016/S0140-6736(03)13490-3.
- Boyle RJ, Tang ML. The role of probiotics in the management of allergic disease. Clin Exp Allergy. 2006 May;36(5):568-76. doi: 10.1111/j.1365-2222.2006.02472.x.
- 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. doi: 10.1111/j.1399-3038.2005.00284.x.
- 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. doi: 10.1111/j.1398-9995.2004.00514.x.
- 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.
- 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.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
March 1, 2007
Primary Completion (Actual)
September 1, 2008
Study Completion (Actual)
January 1, 2009
Study Registration Dates
First Submitted
March 7, 2007
First Submitted That Met QC Criteria
March 7, 2007
First Posted (Estimate)
March 8, 2007
Study Record Updates
Last Update Posted (Estimate)
January 29, 2009
Last Update Submitted That Met QC Criteria
January 28, 2009
Last Verified
January 1, 2009
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- LACTO2
- Eudract number 2007-000209-31
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Vernal Keratoconjunctivitis
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Laboratoires TheaCompletedKeratoconjunctivitis, Vernal
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Santen SASCompletedConjunctivitis, VernalFrance
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Fondazione IRCCS Ca' Granda, Ospedale Maggiore...Completed
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National Taiwan University HospitalUnknownTacrolimus | Vernal Keratoconjunctivitis | Atopic KeratoconjunctivitisTaiwan
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Santen SASCompletedVernal KeratoconjunctivitisUnited States, Croatia, France, Germany, Greece, Hungary, India, Israel, Italy, Portugal, Spain
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Astellas Pharma IncCompletedKeratoconjunctivitis | ConjunctivitisJapan
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Siriraj HospitalCompletedKeratoconjunctivitis, VernalThailand
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Astellas Pharma IncCompletedKeratoconjunctivitis | ConjunctivitisJapan
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Allakos Inc.CompletedVernal Keratoconjunctivitis | Perennial Allergic Conjunctivitis | Atopic KeratoconjunctivitisUnited States
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Fondation Ophtalmologique Adolphe de RothschildCompletedVernal KeratoconjunctivitisFrance
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