Clinical trial NCT06793514: Efficacy and Safety of Oral Probiotics on Ocular Symptoms and Gut Microbiome of Children with Vernal Keratoconjunctivitis
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
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: PHASE1
Conditions: Probiotic
Ocular Surface Disease
Ocular Diseases
Ocular Dryness
Gut Microbiome Dysbiosis
Gut -microbiota
Keywords: Probiotic
Vernal keratoconjunctivitis
Clinical trial
gut microbiome
Lead sponsor: Isfahan University of Medical Sciences
Sponsor class: OTHER
First posted: 2025-01-27
Enrollment: 32
Sex: ALL
Minimum age (years): 4
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.


Eligibility criteria: Inclusion Criteria:1- Patients whose diagnosis of vernal keratoconjunctivitis is confirmed based on clinical criteria. 2-Patients with an age range of 4 to 18 years. 3-Patients who have not received drug treatment for vernal keratoconjunctivitis disease recently.

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Exclusion Criteria:1-Having other eye diseases (except refractive error) 2-Change in the diagnosis of the disease during the study 3-Antibiotics, anti-inflammatory drugs, immunosuppressive drugs 4-History of known gastrointestinal diseases (such as IBD, Celiac,...) 5- History of digestive problems in the last two weeks 6- Lack of consent to participate in the study 7- Having an eye infection in the last one month 8- People who were athletes or involved in intense physical activity 9- Smoking, alcohol and drugs. 10- Using drugs that affect appetite, bowel movements, and nutrient absorption 11- Using prebiotics, probiotics or synbiotics in the last 3 months 12- People who have been on a diet to lose or gain weight in the last 3 months 13- People who have undergone gastrointestinal surgery. 14- Changing the patient's diagnosis in the course of treatment 15- Failure to follow up the patient at the specified times for the visit and assessment of the patient's bed 16- Taking fat-reducing drugs 17-Oral hypoglycemic drugs, insulin, antihypertensive drugs-18- Diuretics, laxatives, antacids 19-Food supplements in the last 3 months.

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Primary outcomes:
measure: The severity of ocular symptoms
timeFrame: One month
measure: Alterations of gut microbiota
timeFrame: One month
Secondary outcomes:
measure: The recurrent rate of disease
timeFrame: Three month
measure: The complications of treatment
timeFrame: Three month
Other outcomes:
Locations:
Study officials:
affiliation: Isfahan University of Medical Sciences, Feiz Hospital, Isfahan Isfahan, Isfahan, Iran
name: Mohsen Pourazizi
role: STUDY_DIRECTOR
References: