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

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

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Ocular Surface Disease; Gut Microbiome Dysbiosis; Probiotic; Ocular Dryness; Ocular Diseases; Gut -microbiota
• Intervention / Treatment: Drug: Probiotic; Drug: Placebo Drug

• Study Type: Interventional
• Enrollment (Estimated): 32
• Phase: Phase 1

Contacts and Locations

• Study Contact: Name: Mohsen Pourazizi; Phone Number: 98 + 09379578055; Email: m.pourazizi@yahoo.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult
• Accepts Healthy Volunteers: No

Description

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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Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Case group: treatment with oral probiotics; In the case group, the patients with vernal keratoconjunctivitis will receive oral probiotics within one month and outcomes will be assessed one month after probiotic therapy.	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.
Placebo Comparator: Placebo group: treatment with placebo.; In the placebo group, the patients with vernal keratoconjunctivitis will receive the placebo substance within one month and outcomes will be assessed one month after treatment.	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	One month
Alterations of gut microbiota	The evaluation of gut microbiota will be conducted at baseline and one month after treatment using real time PCR.	One month

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
The recurrent rate of disease	The recurrent rate of vernal keratoconjunctivitis will be determined after three months of treatment based on clinical manifestations.	Three month
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.	Three month

Collaborators and Investigators

• Sponsor: Mohsen Pourazizi
• Investigators: Study Director: Mohsen Pourazizi, Isfahan University of Medical Sciences, Feiz Hospital, Isfahan Isfahan, Isfahan, Iran

Study record dates

Study Major Dates

• Study Start (Estimated): February 1, 2025
• Primary Completion (Estimated): May 1, 2025
• Study Completion (Estimated): June 1, 2025

Study Registration Dates

• First Submitted: January 21, 2025
• First Submitted That Met QC Criteria: January 21, 2025
• First Posted (Actual): March 25, 2025

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: January 21, 2025
• Last Verified: January 1, 2025

More Information

Terms related to this study

• Keywords: gut microbiome; Clinical trial; Probiotic; Vernal keratoconjunctivitis
• Additional Relevant MeSH Terms: Pathologic Processes; Immune System Diseases; Eye Diseases; Hypersensitivity, Immediate; Hypersensitivity; Corneal Diseases; Conjunctivitis; Conjunctival Diseases; Keratitis; Dysbiosis; Conjunctivitis, Allergic; Keratoconjunctivitis
• Other Study ID Numbers: IR.ARI.MUI.REC.1403.220

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No