Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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).
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| Placebo group | Placebo Comparator | Oral administration of a matched placebo powder. Dosage: one sachet, 2-3 times daily, for 3 months. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Investigational Bifidobacterium Preparation MR-61 | 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. |
| 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. |
| 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 |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Yifeng Yu, Ph.D | Contact | 13979180258 | 171018170@qq.com |
Not provided
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Yifeng Yu | Recruiting | Nanchang | Jiangxi | 330008 | China |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D009216 | Myopia |
| ID | Term |
|---|---|
| D012030 | Refractive Errors |
| D005128 | Eye Diseases |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Placebo for MR-61 | Other | Oral administration of a matched placebo powder. Dosage: one sachet, 2-3 times daily, for 3 months. |
|
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. |