Efficacy and Safety of Oral Probiotics on Ocular Symptoms and Gut Microbiome of Children with Vernal Keratoconjunctivitis
Launched by MOHSEN POURAZIZI · Jan 21, 2025
Trial Information
Current as of June 27, 2025
Not yet recruiting
Keywords
ClinConnect Summary
This clinical trial is studying how oral probiotics—beneficial bacteria that can help our gut health—affect children aged 4 to 18 years who have a condition called vernal keratoconjunctivitis. This condition can cause eye symptoms like itching and redness. The researchers want to find out if taking probiotics can improve these eye symptoms and change the balance of bacteria in the gut, which is important for overall health. The study will compare two groups of children: one will receive the probiotics, while the other will receive a placebo (a treatment that looks like the real thing but doesn’t actually contain the active ingredient).
To be eligible for the trial, children must have a confirmed diagnosis of vernal keratoconjunctivitis and not have received any recent medication for it. They also should not have other eye diseases or certain gastrointestinal issues. Participants will take the probiotics or placebo daily for one month and keep a diary to track their symptoms. This study is not yet recruiting participants, so if you think your child might be interested, keep an eye out for when it starts!
Gender
ALL
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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About Mohsen Pourazizi
Mohsen Pourazizi is a dedicated clinical trial sponsor with a strong commitment to advancing medical research and improving patient outcomes. With a focus on innovative therapeutic solutions, Mr. Pourazizi leads initiatives that prioritize safety, efficacy, and ethical standards in clinical research. His expertise encompasses a wide range of therapeutic areas, fostering collaborations with healthcare professionals and research institutions to drive meaningful advancements in medicine. Under his guidance, clinical trials are designed to meet regulatory requirements while addressing unmet medical needs, ultimately contributing to the development of effective treatments for diverse patient populations.
Contacts
Jennifer Cobb
Immunology at National Institute of Allergy and Infectious Diseases (NIAID)
Locations
Patients applied
Trial Officials
Mohsen Pourazizi
Study Director
Isfahan University of Medical Sciences, Feiz Hospital, Isfahan Isfahan, Isfahan, Iran
Timeline
First submit
Trial launched
Trial updated
Estimated completion
Not reported