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.
None
None
Parallel
Probiotic
DrugThe 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.
Placebo Drug
DrugThe placebo is also prepared in the form of probiotic supplement in the form of sachets with similar packaging by the bio-fermenting pharmaceutical company.
The severity of ocular symptoms
Clinical symptoms (itching, photosensitivity, burning and tearing) and signs (conjunctival hyperemia, chemosis, secretions, Trantas dots and superficial punctate keratitis) are evaluated using slit lamp examination and fluorescent staining and are scored from 0 to 3 points. (0=absence, 1=mild, 2=moderate, 3=severe). At the beginning of the study and one month after the start of the study, the total score of symptoms (range: 0-24) and the score of symptoms (range: 0-30) are calculated as the sum of the scores of each symptom.
Alterations of gut microbiota
The evaluation of gut microbiota will be conducted at baseline and one month after treatment using real time PCR.
The recurrent rate of disease
The recurrent rate of vernal keratoconjunctivitis will be determined after three months of treatment based on clinical manifestations.
The complications of treatment
The potential complications (e.g., abdominal pain, vomiting, diarrhea, allergic reactions, etc) will be assessed one and three months after treatment.
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Mohsen Pourazizi
Lead sponsor
Isfahan University of Medical Sciences
Sponsor institution
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