MR-61 probiotic to slow myopia progression in children and adolescents
Official title: Clinical Efficacy and Mechanism Exploration of MR-61 in Delaying the Progression of Myopia: A Randomized, Double-Blind, Placebo-Controlled Clinical Trial
Run by Second Affiliated Hospital of Nanchang University · NCT07298824 · Data updated 2026-11-12
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 |
| Ages | 3 Years to 18 Years |
| Sex | All |
| Enrollment | 164 (estimated) |
| Sponsor | Second Affiliated Hospital of Nanchang University Academic / other |
| Locations | 1 site (Nanchang, Jiangxi) |
| Status | Recruiting |
| Started | December 1, 2025 |
| Main results expected | July 1, 2027 |
| Study ends | July 30, 2027 |
| Registry record updated | October 15, 2026 |
| Trial ID | NCT07298824 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a 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.
✕Probably 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.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
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.
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 gone: 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.
Who can join: the full rules
Show full inclusion / exclusion 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. No history of orthokeratology (Ortho-K) or defocus spectacle lens wear. 5. Best-corrected distance visual acuity (BCDVA) ≥ 1.0 (decimal notation) in both eyes. 6. The subject has sufficient compliance with the study follow-up. 7. Participant or legal guardian has treatment willingness and provides written informed consent. 8. Other conditions inconsistent with this study. * Exclusion Criteria: 1. Any other concurrent ocular diseases, including various inflammations such as uveitis, glaucoma, cataract, fundus diseases, ocular tumors, or any ocular pathology affecting visual function. 2. Abnormal findings on clinical slit-lamp examination. 3. Presence of amblyopia, manifest strabismus, esotropia, or other congenital ocular diseases. 4. Abnormal intraocular pressure (IOP) or abnormal axial length (AL). 5. Either or both parents with a spherical equivalent (SE) ≤ -6.00 D. 6. Sucrose intolerance, fructose intolerance, glucose-galactose malabsorption syndrome, or sucrase-isomaltase deficiency; or known allergy to any component of the investigational product. 7. Any uncontrolled clinical conditions (e.g., severe psychiatric, neurological, cardiovascular, respiratory, or hematological diseases, or malignant tumors). 8. Active ocular or systemic infection, including fever, or currently receiving antibiotic therapy. 9. Participation in any myopia control clinical trial within the past 3 months or currently participating in one. 10. Previous or current use of rigid gas permeable (RGP) contact lenses (including care products), multifocal contact lenses, progressive multifocal spectacle lenses, or other specially designed myopia control lenses, light therapy devices (e.g., repeated low-level red-light therapy), or low-concentration atropine. 11. History of systemic use of antidepressants, antihistamines, anticholinergics, antipsychotics, diuretics, contraceptives, systemic chemotherapeutic agents, sex hormones, or immunomodulators within the past 2 months. 12. Poor lifestyle habits or environment: smoking, alcohol abuse, etc. 13. Any other conditions deemed unsuitable for this study by the investigators.
Where it's running
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Yifeng Yu
Nanchang, Jiangxi, China Recruiting
Study contacts
- Study coordinator: Yifeng Yu, Ph.D
- Email: 171018170@qq.com
- Phone: 13979180258
How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.