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

NCT06793514 | Not Yet Recruiting Phase 1

• 1 other identifier: IR.ARI.MUI.REC.1403.220
• Study Type: interventional
• Target: 32
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Probiotic; Ocular Surface Disease; Ocular Diseases; Ocular Dryness; Gut Microbiome Dysbiosis; Gut -microbiota

Keywords

Probiotic; Vernal keratoconjunctivitis; Clinical trial; gut microbiome

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (2)

• The recurrent rate of disease

  Three month

• The complications of treatment

  Three month

Study Arms (2)

Case group: treatment with oral probiotics

EXPERIMENTAL

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

Placebo group: treatment with placebo.

PLACEBO COMPARATOR

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

Interventions

Probiotic DRUG

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.

Case group: treatment with oral probiotics

Placebo Drug 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.

Placebo group: treatment with placebo.

Eligibility Criteria

• Age: 4 Years - 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

Sponsors & Collaborators

• Mohsen Pourazizi: lead

MeSH Terms

Conditions

Conjunctivitis, Allergic

Interventions

Probiotics

Condition Hierarchy (Ancestors)

Conjunctivitis; Conjunctival Diseases; Eye Diseases; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases

Intervention Hierarchy (Ancestors)

Dietary Supplements; Food; Diet, Food, and Nutrition; Physiological Phenomena; Food and Beverages

Study Officials

• Mohsen Pourazizi

  Isfahan University of Medical Sciences, Feiz Hospital, Isfahan Isfahan, Isfahan, Iran

  STUDY DIRECTOR

Central Study Contacts

Mohsen Pourazizi

CONTACT

98 + 09379578055; m.pourazizi@yahoo.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, CARE PROVIDER
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Assistant Professor of Ophthalmology

Study Record Dates

• First Submitted: January 21, 2025
• First Posted: January 27, 2025
• Study Start: February 1, 2025
• Primary Completion: May 1, 2025
• Study Completion: June 1, 2025
• Last Updated: January 27, 2025

Record last verified: 2025-01