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NOT YET RECRUITING
NCT06793514
PHASE1

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

Sponsor: Mohsen Pourazizi

View on ClinicalTrials.gov

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.

Official title: Efficacy and Safety of Oral Probiotics on Ocular Symptoms and Gut Microbiome of Children with Vernal Keratoconjunctivitis: a Double-blind Clinical Trial Study

Key Details

Gender

All

Age Range

4 Years - 18 Years

Study Type

INTERVENTIONAL

Enrollment

32

Start Date

2025-02-01

Completion Date

2025-06-01

Last Updated

2025-01-27

Healthy Volunteers

No

Interventions

DRUG

Probiotic

The experimental group will receive the oral probiotics (Lactobacillus casei, Lactobacillus rhamnosus, Lactobacillus acidophilus, Lactobacillus bulgaricus, Bifidobacterium breve, Bifidobacterium infantis, Streptococcus thermophiles) alongside with fructooligosaccharide (FOS), which is prepared in the concentration of 109 cfu by Bisot Khimr and is in the form of an edible sachet that can be dissolved in cold water, which is consumed once a day for one month. Sachets should be stored at a temperature of 2 to 8 degrees Celsius (in the refrigerator), which increases the useful life of probiotic bacteria and makes them more effective.

DRUG

Placebo Drug

The placebo is also prepared in the form of probiotic supplement in the form of sachets with similar packaging by the bio-fermenting pharmaceutical company.