drugset / Trial / NCT06793514

Efficacy and Safety of Oral Probiotics on Ocular Symptoms and Gut Microbiome of Children with Vernal Keratoconjunctivitis

NCT06793514

Phase 1 Not yet recruiting 32 enrolled Mohsen Pourazizi
RandomizedParallel-groupDouble-blindTreatment

Summary

The primary goal of this study is to determine the effects of oral probiotics on the severity of ocular symptoms and the alterations of the gut microbiome of children (4-18 years old) with vernal keratoconjunctivitis. The current study will also assess the safety of oral probiotics among children with vernal keratoconjunctivitis. The main questions it aims to answer: 1- Does treatment with oral probiotics improve the severity of ocular symptoms in children with vernal keratoconjunctivitis? 2- Does treatment with oral probiotics alter the gut microbiome of children with vernal keratoconjunctivitis? Researchers will compare the ocular symptoms and gut microbiome between two groups receiving oral probiotics and placebo among children with vernal keratoconjunctivitis. Participants The participants will receive the oral probiotics and placebo ever day for one month. Record their regimen and keep a diary of their symptoms.

Timeline

Start
2025-02-01
Primary completion
2025-05-01
Completion
2025-06-01

Drugs

EvaluationDrugModalityDoseRoute
Subject Bifidobacterium breve Other / unclassified Oral
Subject Bifidobacterium infantis Other / unclassified Oral
Subject Lactobacillus acidophilus Other / unclassified Oral
Subject Lactobacillus bulgaricus Unknown Oral
Subject Lactobacillus casei Unknown Oral
Subject Lactobacillus rhamnosus Other / unclassified Oral
Subject Streptococcus thermophiles Unknown Oral
Subject fructooligosaccharide Unknown Oral

Indications