A Phase 2 interventional study of Investigational Bifidobacterium Preparation MR-61 and Placebo for MR-61 in Myopia Progressing, sponsored by Second Affiliated Hospital of Nanchang University. Recruiting at 1 site in China. Open to participants aged 3 Years to 18 Years. Per ClinicalTrials.gov, last updated 2025-12-23.
Sponsored by Second Affiliated Hospital of Nanchang University · Phase 2, Interventional, and Prevention
To investigate whether probiotic MR-61 can assist in slowing down the progression rate of myopia (a prospective randomized controlled study).
To investigate whether probiotic MR-61 can assist in slowing down the progression rate of myopia (a prospective randomized controlled study).
984 studies on the registry are indexed under Myopia; 210 are open to participants now.
This study's planned enrollment of 164 is above the median of 80 across 783 interventional studies indexed under Myopia.
Browse Myopia studies →Second Affiliated Hospital of Nanchang University is the lead sponsor of 78 studies on the registry; 47 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
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 a matched placebo powder. Dosage: one sachet, 2-3 times daily, for 3 months.
Other: Placebo for 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.
Oral administration of a matched placebo powder. Dosage: one sachet, 2-3 times daily, for 3 months.
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.
Time frame: Measured at baseline, 1, 3, 6, 9, 12, 13, 14, 19, and 25 months post-intervention.
Change in Axial Length
The growth value of ocular axial length, measured in millimeters (mm).
Time frame: 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).
Time frame: 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).
Time frame: 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).
Time frame: 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).
Time frame: 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)
Time frame: 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).
Time frame: 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).
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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).
Time frame: 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.
Time frame: Fecal and blood serum samples collected at baseline, 3, 6, 12, and 25 months post-intervention for metabolite analysis.
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Second Affiliated Hospital of Nanchang University