Myopia ProgressingPhase 2NCT07298824
Clinical Efficacy and Mechanism Exploration of MR-61 in Delaying the Progression of Myopia
A Phase 2 study testing Investigational Bifidobacterium Preparation MR-61 in people with Myopia Progressing, run by Second Affiliated Hospital of Nanchang University at 1 site in China.
Trial summary
To investigate whether probiotic MR-61 can assist in slowing down the progression rate of myopia (a prospective randomized controlled study). Read more about this study
- Who is it for?
- Ages 3 to 18 years
- Conditions the study is for
- Myopia Progressing
- What is being tested?
- Investigational Bifidobacterium Preparation MR-61
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 164 participants
- Where
- 1 siteChina
- Study dates
- 1 Dec 2025to 30 Jul 2027
- Phase
- Phase 2
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 3 to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- 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.
- No history of orthokeratology (Ortho-K) or defocus spectacle lens wear.
- Best-corrected distance visual acuity (BCDVA) ≥ 1.0 (decimal notation) in both eyes.
- The subject has sufficient compliance with the study follow-up.
- Participant or legal guardian has treatment willingness and provides written informed consent.
- Other conditions inconsistent with this study.
Who cannot join
- Any other concurrent ocular diseases, including various inflammations such as uveitis, glaucoma, cataract, fundus diseases, ocular tumors, or any ocular pathology affecting visual function.
- Abnormal findings on clinical slit-lamp examination.
- Presence of amblyopia, manifest strabismus, esotropia, or other congenital ocular diseases.
- Abnormal intraocular pressure (IOP) or abnormal axial length (AL).
- Either or both parents with a spherical equivalent (SE) ≤ -6.00 D.
- Sucrose intolerance, fructose intolerance, glucose-galactose malabsorption syndrome, or sucrase-isomaltase deficiency; or known allergy to any component of the investigational product.
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- Any uncontrolled clinical conditions (e.g., severe psychiatric, neurological, cardiovascular, respiratory, or hematological diseases, or malignant tumors).
- Active ocular or systemic infection, including fever, or currently receiving antibiotic therapy.
- Participation in any myopia control clinical trial within the past 3 months or currently participating in one.
- 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.
- History of systemic use of antidepressants, antihistamines, anticholinergics, antipsychotics, diuretics, contraceptives, systemic chemotherapeutic agents, sex hormones, or immunomodulators within the past 2 months.
- Poor lifestyle habits or environment: smoking, alcohol abuse, etc.
- Any other conditions deemed unsuitable for this study by the investigators.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Yifeng Yu
Nanchang, Jiangxi, 330008
yifeng Yu, Ph.D, +8613979180258, 171018170@qq.com
About this study
Official title: 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).
Read the detailed description
To investigate whether probiotic MR-61 can assist in slowing down the progression rate of myopia (a prospective randomized controlled study).
- Conditions
- Myopia Progressing
- Being tested
- Investigational Bifidobacterium Preparation MR-61, Placebo for MR-61
- Keywords
- Myopia,Probiotics,Gut microbiota
- Medical subject headings
- Myopia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Investigational Bifidobacterium Preparation MR-61Biological
Oral administration of the investigational probiotic powder MR-61. The primary component is Bifidobacterium. Dosage: one sachet, 2-3 times daily, for 3 months (from Month 3 to Month 6 of the study).
Placebo for MR-61Other
Oral administration of a matched placebo powder. Dosage: one sachet, 2-3 times daily, for 3 months (from Month 3 to Month 6 of the study).
| Study group | Role | What they receive |
|---|---|---|
| Probiotic group | Active comparator | Oral administration of the investigational probiotic powder MR-61. The primary component is Bifidobacterium. Dosage: one sachet, 2-3 times daily, for 3 months. Receives: Biological: Investigational Bifidobacterium Preparation MR-61 |
| Placebo group | Placebo comparator | Oral administration of a matched placebo powder. Dosage: one sachet, 2-3 times daily, for 3 months. Receives: Other: Placebo for MR-61 |
What is being measured
The primary outcome is the main question the study is designed to answer.
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: Measured at baseline, 1, 3, 6, 9, 12, 13, 14, 19, and 25 months post-enrollment
Secondary outcomes (14)
Change in Axial Length
The growth value of ocular axial length, measured in millimeters (mm).
Measured: Measured at baseline, 1, 3, 6, 9, 12, 13, 14, 19, and 25 months post-enrollment
Change in Corneal Curvature
The change in corneal curvature (keratometry), measured in diopters (D).
Measured: Measured at baseline, 1, 3, 6, 9, 12, 13, 14, 19, and 25 months post-enrollment
Change in Binocular Anisometropia
The difference in spherical equivalent refraction between the two eyes, measured in diopters (D).
Measured: Measured at baseline, 1, 3, 6, 9, 12, 13, 14, 19, and 25 months post-enrollment
Change in Anterior Chamber Depth
The change in depth of the anterior chamber of the eye, measured in millimeters (mm).
Measured: Measured at baseline, 1, 3, 6, 9, 12, 13, 14, 19, and 25 months post-enrollment
Change in Lens Thickness
The change in thickness of the crystalline lens, measured in millimeters (mm).
Measured: Measured at baseline, 1, 3, 6, 9, 12, 13, 14, 19, and 25 months post-enrollment
Change in Vitreous Cavity Depth
The change in depth of the vitreous cavity, measured in millimeters (mm)
Measured: Measured at baseline, 1, 3, 6, 9, 12, 13, 14, 19, and 25 months post-enrollment
Change in Far Phoria Degree
The degree of heterophoria for distance vision, measured in prism diopters (PD).
Measured: Measured at baseline, 1, 3, 6, 9, 12, 13, 14, 19, and 25 months post-enrollment
Change in Near Phoria Degree
The degree of heterophoria for near vision, measured in prism diopters (PD).
Measured: Measured at baseline, 1, 3, 6, 9, 12, 13, 14, 19, and 25 months post-enrollment
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.
Measured: 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.
Measured: Measured at baseline, 1, 3, 6, 9, 12, 13, 14, 19, and 25 months post-enrollment
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.
Measured: Measured at baseline, 1, 3, 6, 9, 12, 13, 14, 19, and 25 months post-enrollment
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.
Measured: Measured at baseline, 1, 3, 6, 9, 12, 13, 14, 19, and 25 months post-enrollment
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).
Measured: Fecal samples collected at baseline, 3, 6, 12, and 25 months post-enrollment 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.
Measured: Fecal and blood serum samples collected at baseline, 3, 6, 12, and 25 months post-enrollment for metabolite analysis.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Dec 2025
- Study start1 Dec 2025
- Primary completion1 Jul 2027 (estimated)
- Study completion30 Jul 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Myopia ProgressingStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 164 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Second Affiliated Hospital of Nanchang University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Yifeng Yu, Second Affiliated Hospital of Nanchang University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07298824
- Sponsor's protocol ID
- I-Yiyan Lun Shen[2025]No.(104)
- Status last verified
- Dec 2025
- First submitted
- 23 Nov 2025
- Last updated
- 15 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided