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

NCT ID: NCT07298824

Last Updated: 2025-12-23

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

PHASE2

Total Enrollment

164 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-10-01

Study Completion Date

2027-07-01

Brief Summary

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

Detailed Description

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

Conditions

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Myopia Progressing

Keywords

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Myopia,Probiotics,Gut microbiota

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

DOUBLE

Participants Outcome Assessors

Study Groups

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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.

Group Type ACTIVE_COMPARATOR

Investigational Bifidobacterium Preparation MR-61

Intervention Type BIOLOGICAL

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 group

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

Group Type PLACEBO_COMPARATOR

Placebo for MR-61

Intervention Type OTHER

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

Interventions

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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.

Intervention Type BIOLOGICAL

Placebo for MR-61

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

Intervention Type OTHER

Eligibility Criteria

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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.
Minimum Eligible Age

3 Years

Maximum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Second Affiliated Hospital of Nanchang University

OTHER

Sponsor Role lead

Responsible Party

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Yifeng Yu

Associate Chief Physician, Ph.D.

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Yifeng Yu

Nanchang, Jiangxi, China

Site Status RECRUITING

Countries

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China

Central Contacts

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Yifeng Yu, Ph.D

Role: CONTACT

Phone: 13979180258

Email: [email protected]

Facility Contacts

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yifeng Yu, Ph.D

Role: primary

Other Identifiers

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IIT-I-2025-082

Identifier Type: -

Identifier Source: org_study_id