Clinical Efficacy and Mechanism Exploration of MR-61 in Delaying the Progression of Myopia

Nanchang University

Status and phase: Enrolling; Phase 2

Conditions: Myopia Progressing

Treatments: Biological: Investigational Bifidobacterium Preparation MR-61; Other: Placebo for MR-61

Study type: Interventional

Funder types: Other

Identifiers

NCT07298824

IIT-I-2025-082

Details and patient eligibility

About

To investigate whether probiotic MR-61 can assist in slowing down the progression rate of myopia (a prospective randomized controlled study).

Full description

To investigate whether probiotic MR-61 can assist in slowing down the progression rate of myopia (a prospective randomized controlled study).

Enrollment: 164 estimated patients

Sex: All

Ages: 3 to 18 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Myopia is defined as spherical equivalent (SE) ≤ -0.5D.
2. Aged between 3 and 18 years, with no restriction on gender.
3. Cylinder power ≤ 1.50D; anisometropia of SE between both eyes ≤ 1.50D.
4. The subject has sufficient compliance with the study follow-up; the subject or their guardian has the intention to receive treatment and has signed the informed consent form.

Exclusion criteria

1. Presence of other concomitant ocular diseases;
2. Abnormal findings on clinical slit-lamp examination;
3. Existence of amblyopia, manifest strabismus, esotropia, or other congenital ocular diseases;
4. Individuals with abnormal intraocular pressure or abnormal axial length of the eye;
5. Either or both parents having a spherical equivalent (SE) ≤ -6.00D;
6. Other conditions inconsistent with this study.

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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164 participants in 2 patient groups, including a placebo group

Probiotic group

Active Comparator group

Description:

Oral administration of the investigational probiotic powder MR-61. The primary component is Bifidobacterium. Dosage: one sachet, 2-3 times daily, for 3 months.

Treatment:

Biological: Investigational Bifidobacterium Preparation MR-61

Placebo group

Placebo Comparator group

Description:

Oral administration of a matched placebo powder. Dosage: one sachet, 2-3 times daily, for 3 months.

Treatment:

Other: Placebo for MR-61