Ignite Creation Date:
2025-12-25 @ 4:10 AM
Ignite Modification Date:
2025-12-26 @ 3:07 AM
Study NCT ID:
NCT00445120
Status:
COMPLETED
Last Update Posted:
2009-01-29
First Post:
2007-03-07
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Lactobacillus Rhamnosus GG Oral Treatment Efficacy on Vernal Keratoconjunctivitis Treatment
Sponsor:
Campus Bio-Medico University
Organization:
Study Overview
Official Title:
Multicenter, Randomised, Double Masked, Controlled Studies on the Efficacy of Lactobacillus Rhamnosus GG Treatment in Preventing Vernal Keratoconjunctivitis VKC) Relapses.
Status:
COMPLETED
Status Verified Date:
2009-01
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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.
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 Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
Secondary ID Infos
| Secondary ID | Type | Domain | Link | View |
|---|---|---|---|---|
| Eudract number 2007-000209-31 | None | None | View |