RecruitingPhase 2NCT07298824

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

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


Sponsor

Second Affiliated Hospital of Nanchang University

Enrollment

164 participants

Start Date

Oct 1, 2025

Study Type

INTERVENTIONAL

Conditions

Summary

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


Eligibility

Min Age: 3 YearsMax Age: 18 Years

Inclusion Criteria4

  • Myopia is defined as spherical equivalent (SE) ≤ -0.5D.
  • Aged between 3 and 18 years, with no restriction on gender.
  • Cylinder power ≤ 1.50D; anisometropia of SE between both eyes ≤ 1.50D.
  • 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 Criteria6

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

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Interventions

BIOLOGICALInvestigational Bifidobacterium Preparation MR-61

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

OTHERPlacebo for MR-61

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


Locations(1)

Yifeng Yu

Nanchang, Jiangxi, China

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NCT07298824