Efficacy of N-163 strain of <i>Aureobasidium pullulans</i> -produced beta-glucan in improving muscle strength and function in patients with Duchenne muscular dystrophy; Results of a 6-month non-randomised open-label linear clinical trial
Bibliographic record
Abstract
Abstract Duchenne muscular dystrophy (DMD) is a debilitating genetic disease that causes gradual muscle weakening and early mortality. After a 45-day clinical pilot study and a pre-clinical study in mdx mice demonstrating safety and efficacy, and anti-fibrotic and anti-inflammatory effects, respectively, of an Aureobasidium pullulans N-163 strain-produced B-1,3–1,6-glucan. We conducted this linear six-month clinical study to assess its efficacy. Twelve ambulatory and 12 non-ambulatory individuals with DMD were included; all received the N-163 strain of A.pullulans produed beta-glucan dietary supplement orally in addition to the standard treatment regimen, which included steroids. The Medical Research Council muscle score improved in 11 patients in the ambulatory group and in 8 patients in the non-ambulatory group. The six-minute walk test distance improved in nine patients, with a 29.5-meter average improvement. The North Star Ambulatory Assessment improved by 1 unit in three patients. This safe beta-glucan food supplement improved muscle function within 6 months. A comprehensive, multi-centric clinical research should be conducted for unravelling its potential as a disease-modifying drug adjuvant in DMD.
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How this classification was reachedexpand
Full frame machine prediction
Teacher imitationNot calibrated prevalence, not ground truth. Human validation pending. The Gemma side is a direct model label for every work in the frame, read from the title-only record. The Codex side is a classifier learned from the 10,348 direct Codex labels and calibrated to design-weighted sample rates; fields without enough sample support carry no Codex call. Candidate is the union of the two sides; consensus is their intersection. These outputs are machine_predicted_unvalidated and are not human labels.
Distilled classifier scores by category (both heads)
| Category | Codex | Gemma |
|---|---|---|
| Metaresearch | 0.001 | 0.001 |
| Meta-epidemiology (narrow) | 0.001 | 0.000 |
| Meta-epidemiology (broad) | 0.002 | 0.001 |
| Bibliometrics | 0.000 | 0.000 |
| Science and technology studies | 0.000 | 0.001 |
| Scholarly communication | 0.000 | 0.001 |
| Open science | 0.001 | 0.000 |
| Research integrity | 0.001 | 0.001 |
| Insufficient payload (model declined to judge) | 0.002 | 0.000 |
Machine scores (provisional)
The two teacher heads of the student model, read on this work. A score orders the frame for review; it never asserts a category, and the validation status ships verbatim with every row.
Baseline scores from an immature model (maturity gate not passed, 7 training rounds). Scores rank; they never assert a category.
score_only:v0-immature-baseline · verbatim from the scoring run: score_only means the number may rank works, and no category label ships from itClassification
machine, unvalidatedMachine predicted; a candidate call from one source (direct Gemma or distilled Codex), not a consensus.
How this classification was reached, model by model and score by score, is at the end of the page under "How this classification was reached".