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

Mohsen Pourazizi

Status and phase: Not yet enrolling; Phase 1

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

Treatments: Drug: Placebo Drug; Drug: Probiotic

Study type: Interventional

Funder types: Other

Identifiers

NCT06793514

IR.ARI.MUI.REC.1403.220

Details and patient eligibility

About

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.

Enrollment: 32 estimated patients

Sex: All

Ages: 4 to 18 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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.

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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32 participants in 2 patient groups, including a placebo group

Case group: treatment with oral probiotics

Experimental group

Description:

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.

Treatment:

Drug: Probiotic

Placebo group: treatment with placebo.

Placebo Comparator group

Description:

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.

Treatment:

Drug: Placebo Drug