NCT00445120

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
48

participants targeted

Target at P25-P50 for phase_2

Timeline
Completed

Started Mar 2007

Geographic Reach
1 country

3 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2007

Completed
6 days until next milestone

First Submitted

Initial submission to the registry

March 7, 2007

Completed
1 day until next milestone

First Posted

Study publicly available on registry

March 8, 2007

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2008

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2009

Completed
Last Updated

January 29, 2009

Status Verified

January 1, 2009

Enrollment Period

1.5 years

First QC Date

March 7, 2007

Last Update Submit

January 28, 2009

Conditions

Vernal Keratoconjunctivitis

Keywords

Vernal keratoconjunctivitisprobioticLactobacillus Rhamnosus GGChildrenClinical trial

Outcome Measures

Primary Outcomes (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,

    2 years

Secondary Outcomes (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

    2 years

Study Arms (2)

1

EXPERIMENTAL
Drug: Lactobacillus Rhamnosus GG

2

PLACEBO COMPARATOR
Drug: placebo (sugar)

Interventions

Lactobacillus Rhamnosus GGDRUG

patients are treated with oral Lactobacillus Rhamnosus GG once daily for six months

1
placebo (sugar)DRUG

Placebo will be administered to patients once daily for six months

2

Eligibility Criteria

Age5 Years - 16 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

University of Genova

Genova, Italy

Location

University of Padua

Padua, Italy

Location

University Campus Bio-Medico

Rome, 00155, Italy

Location

Related Publications (7)

  • 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.

    PMID: 11297958BACKGROUND

  • 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.

    PMID: 12788576BACKGROUND

  • 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.

    PMID: 16650040BACKGROUND

  • 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.

    PMID: 16101937BACKGROUND

  • 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.

    PMID: 15727582BACKGROUND

  • 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.

    PMID: 10857837BACKGROUND

  • 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.

    PMID: 12052387BACKGROUND

MeSH Terms

Conditions

Conjunctivitis, Allergic

Interventions

Sugars

Condition Hierarchy (Ancestors)

ConjunctivitisConjunctival DiseasesEye DiseasesHypersensitivity, ImmediateHypersensitivityImmune System Diseases

Intervention Hierarchy (Ancestors)

Carbohydrates

Study Officials

  • Stefano Bonini, MD

    University Campus Bio-Medico

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
CROSSOVER
Sponsor Type
OTHER

Study Record Dates

First Submitted

March 7, 2007

First Posted

March 8, 2007

Study Start

March 1, 2007

Primary Completion

September 1, 2008

Study Completion

January 1, 2009

Last Updated

January 29, 2009

Record last verified: 2009-01

Locations

IT(3)