MR-61 probiotic to slow myopia progression in children and adolescents

Clinical Efficacy and Mechanism Exploration of MR-61 in Delaying the Progression of Myopia: A Randomized, Double-Blind, Placebo-Controlled Clinical Trial

This trial will test whether a probiotic called MR-61 can slow down myopia progression in children and teens aged 3 to 18.

Quick facts

• Phase: Phase 2
• Study type: Interventional
• Enrollment: 164 (estimated)
• Ages: 3 Years to 18 Years
• Sex: All
• Sponsor: Second Affiliated Hospital of Nanchang University (Academic / other)
• Locations: 1 site (Nanchang, Jiangxi)
• Trial ID: NCT07298824 on ClinicalTrials.gov

What this trial studies

This Phase 2, randomized, placebo-controlled study will give participants either the Bifidobacterium preparation MR-61 or a matching placebo and follow them prospectively to measure changes in refractive error and eye growth. Eligible participants are 3–18 years old with myopia (spherical equivalent ≤ −0.5 D) and limited astigmatism and anisometropia; those with other ocular diseases or very high parental myopia are excluded. Primary outcomes include change in spherical equivalent (and typically axial length) over the study period, while investigators will also explore shifts in gut microbiota to probe possible mechanisms. The trial is conducted at a single site and requires in-person visits for treatment and follow-up measurements.

Who should consider this trial

Good fit: Children and adolescents aged 3–18 with myopia (SE ≤ −0.5 D), cylinder ≤ 1.50 D, anisometropia ≤ 1.50 D, good follow-up compliance, and no other ocular disease are ideal candidates.

Not a fit: Patients outside the 3–18 age range, those with other ocular diseases or abnormal intraocular pressure or axial length, or those with very high parental myopia (parental SE ≤ −6.00 D) are unlikely to benefit from this study.

Why it matters

Potential benefit: If successful, MR-61 could slow the rate of myopia progression in children, potentially lowering the risk of developing high myopia and its long-term complications.

How similar studies have performed: Using probiotics to influence myopia is a novel approach with limited human data, although preclinical and observational studies have suggested a possible gut–eye connection.

Eligibility criteria

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.

Where this trial is running

Nanchang, Jiangxi

• Yifeng Yu — Nanchang, Jiangxi, China (Recruiting)

Study contacts

• Study coordinator: Yifeng Yu, Ph.D

Conditions Myopia Progressing; Myopia,Probiotics,Gut microbiota