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

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

Study Overview

• Status: Recruiting
• Conditions: Myopia Progressing
• Intervention / Treatment: Biological: Investigational Bifidobacterium Preparation MR-61; Other: Placebo for MR-61

Detailed Description

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

• Study Type: Interventional
• Enrollment (Estimated): 164
• Phase: Phase 2

Contacts and Locations

• Study Contact: Name: Yifeng Yu, Ph.D; Phone Number: 13979180258; Email: 171018170@qq.com

Study Locations

• China
  • Jiangxi
    • Nanchang, Jiangxi, China, 330008
      • Recruiting
      • Yifeng Yu
      • Contact: yifeng Yu, Ph.D; Phone Number: +8613979180258; Email: 171018170@qq.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Probiotic group; Oral administration of the investigational probiotic powder MR-61. The primary component is Bifidobacterium. Dosage: one sachet, 2-3 times daily, for 3 months.	Biological: Investigational 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.
Placebo Comparator: Placebo group; Oral administration of a matched placebo powder. Dosage: one sachet, 2-3 times daily, for 3 months.	Other: Placebo for MR-61; Oral administration of a matched placebo powder. Dosage: one sachet, 2-3 times daily, for 3 months.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in Spherical Equivalent Refraction	The change in spherical equivalent refraction (SER) from baseline to each follow-up visit, measured in diopters (D). SER is calculated as the spherical power plus half of the cylindrical power. A negative change indicates an increase in myopia.	Measured at baseline, 1, 3, 6, 9, 12, 13, 14, 19, and 25 months post-intervention.

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in Axial Length	The growth value of ocular axial length, measured in millimeters (mm).	Measured at baseline, 1, 3, 6, 9, 12, 13, 14, 19, and 25 months post-intervention.
Change in Corneal Curvature	The change in corneal curvature (keratometry), measured in diopters (D).	Measured at baseline, 1, 3, 6, 9, 12, 13, 14, 19, and 25 months post-intervention.
Change in Binocular Anisometropia	The difference in spherical equivalent refraction between the two eyes, measured in diopters (D).	Measured at baseline, 1, 3, 6, 9, 12, 13, 14, 19, and 25 months post-intervention.
Change in Anterior Chamber Depth	The change in depth of the anterior chamber of the eye, measured in millimeters (mm).	Measured at baseline, 1, 3, 6, 9, 12, 13, 14, 19, and 25 months post-intervention.
Change in Lens Thickness	The change in thickness of the crystalline lens, measured in millimeters (mm).	Measured at baseline, 1, 3, 6, 9, 12, 13, 14, 19, and 25 months post-intervention.
Change in Vitreous Cavity Depth	The change in depth of the vitreous cavity, measured in millimeters (mm)	Measured at baseline, 1, 3, 6, 9, 12, 13, 14, 19, and 25 months post-intervention.
Change in Far Phoria Degree	The degree of heterophoria for distance vision, measured in prism diopters (PD).	Measured at baseline, 1, 3, 6, 9, 12, 13, 14, 19, and 25 months post-intervention.
Change in Near Phoria Degree	The degree of heterophoria for near vision, measured in prism diopters (PD).	Measured at baseline, 1, 3, 6, 9, 12, 13, 14, 19, and 25 months post-intervention.
Score on the National Eye Institute Visual Function Questionnaire - 25 (NEI VFQ-25)	Visual quality and vision-related quality of life is assessed using the National Eye Institute Visual Function Questionnaire - 25 (NEI VFQ-25). The overall composite score ranges from 0 to 100, where a higher score represents better visual function and quality of life.	Assessed at baseline, 1, 3, 6, 9, 12, 13, 14, 19, and 25 months post-intervention.
Score on the Montreal Cognitive Assessment (MoCA)	Cognitive function is assessed using the Montreal Cognitive Assessment (MoCA), a widely used screening test for cognitive impairment. The total score ranges from 0 to 30, with a score of 26 or higher considered normal. As probiotic supplementation may influence cognitive function, this will be considered in the interpretation of results.	Assessed at baseline, 1, 3, 6, 9, 12, 13, 14, 19, and 25 months post-intervention.
Score on the Gastrointestinal Symptom Rating Scale (GSRS)	Gastrointestinal symptoms are assessed using the Gastrointestinal Symptom Rating Scale (GSRS), a validated questionnaire covering reflux, abdominal pain, indigestion, diarrhea, and constipation. Each symptom is rated on a scale from 0 (no discomfort) to 6 (very severe discomfort). A higher total or subscale score indicates more severe gastrointestinal symptoms (worse outcome). As probiotic supplementation may influence gastrointestinal function, this will be considered in the interpretation of results.	Assessed at baseline, 1, 3, 6, 9, 12, 13, 14, 19, and 25 months post-intervention.
Score on the World Health Organization Quality of Life Brief Version (WHOQOL-BREF)	Participant adaptation and overall quality of life are assessed using the World Health Organization Quality of Life Brief Version (WHOQOL-BREF), a validated generic quality of life instrument. It covers physical health, psychological health, social relationships, and environment domains. The total score is transformed to range from 0 to 100, where a higher score indicates a better quality of life and better adaptation. As probiotic supplementation may influence overall well-being, this will be considered in the interpretation of results.	Assessed at baseline, 1, 3, 6, 9, 12, 13, 14, 19, and 25 months post-intervention.
Change in gut microbiota composition and diversity assessed by 16S rRNA gene sequencing	Fecal samples collected before and after intervention are analyzed using full-length 16S rRNA gene sequencing. Key metrics include changes in alpha diversity indices (e.g., Shannon Index, observed species), beta diversity (e.g., weighted/unweighted UniFrac distance), and relative abundance of specific bacterial taxa (e.g., phylum Firmicutes/Bacteroidota ratio, genus Bifidobacterium).	Fecal samples collected at baseline, 3, 6, 12, and 25 months post-intervention for sequencing analysis.
Change in concentrations of fecal and serum metabolites	Targeted metabolomic analysis is performed on fecal and blood serum samples. Concentrations of specific metabolites (e.g., short-chain fatty acids, bile acids, or inflammatory cytokines) are measured and reported in nanomolar (nM) or picograms per milliliter (pg/mL) concentrations, as applicable.	Fecal and blood serum samples collected at baseline, 3, 6, 12, and 25 months post-intervention for metabolite analysis.

Collaborators and Investigators

• Sponsor: Second Affiliated Hospital of Nanchang University

Study record dates

Study Major Dates

• Study Start (Actual): October 1, 2025
• Primary Completion (Estimated): July 1, 2027
• Study Completion (Estimated): July 1, 2027

Study Registration Dates

• First Submitted: November 23, 2025
• First Submitted That Met QC Criteria: December 20, 2025
• First Posted (Actual): December 23, 2025

Study Record Updates

• Last Update Posted (Actual): December 23, 2025
• Last Update Submitted That Met QC Criteria: December 20, 2025
• Last Verified: December 1, 2025

More Information

Terms related to this study

• Keywords: Myopia,Probiotics,Gut microbiota
• Additional Relevant MeSH Terms: Eye Diseases; Refractive Errors; Myopia
• Other Study ID Numbers: IIT-I-2025-082

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No