Post-stroke dysphagia (PSD) is a frequent, disabling complication of ischemic stroke. Because acupotomy has limited effects on swallowing and gut–brain axis modulation with probiotics may support neural repair, we performed a single-center, randomized, double-blind (for probiotic/placebo allocation), placebo-controlled trial to test whether adjunctive Bifidobacterium longum ( B. longum ) SX-1326 enhances swallowing recovery in ischemic PSD. Between September 2023 and September 2024, 100 patients with confirmed PSD were randomized (1:1) to receive acupotomy plus B. longum SX-1326 (2 g twice daily) or acupotomy plus placebo for 4 weeks. Swallowing outcomes were assessed using WST, standardized swallowing assessment (SSA), and SWAL-QOL; secondary endpoints included nutritional indices, neuro-injury and neurotrophic biomarkers (NSE, NPY, IGF-1, BDNF, GFAP, GDF-15), inflammatory cytokines (IL-1β, IL-6, TNF-α, CRP), and fecal microbiota profiles (16S rRNA sequencing). Compared with placebo, the probiotic group achieved greater improvements in WST, SSA, and SWAL-QOL, higher cure rates, better nutritional recovery, reduced neuro-injury and inflammatory markers, and increased neurotrophic factors (all P < 0.05). Fecal microbiota profiling (16S rRNA sequencing) showed increased microbial diversity and an enrichment of Bifidobacterium , Coprococcus , and Collinsella in the probiotic group. 16S-based in silico functional inference suggested a relative increase in the pyruvate-to-L-lactate fermentation pathway. These microbiome and predicted functional shifts were associated with clinical improvement and should be considered hypothesis-generating; causality cannot be inferred from correlation-based analyses, and direct metabolite quantification (e.g., SCFAs, lactate) in future studies is required to validate these functional predictions. Trial Registration: Chinese Clinical Trial Registry (ChiCTR2300075164, http://www.chictr.org.cn/ ), registered on August 28, 2023. A randomized, double-blind, placebo-controlled trial evaluated 4-week acupotomy combined with B. longum SX-1326 versus acupotomy plus placebo in patients with post-stroke dysphagia. The co-therapy improved swallowing function and quality of life, attenuated inflammatory responses (↓IL-1β, ↓TNF-α), and enhanced neurotrophic support (↑BDNF). Concomitantly, gut microbial diversity increased with enrichment of beneficial genera (e.g., Bifidobacterium , Coprococcus , Collinsella ), suggesting modulation of the gut–brain axis as a potential mechanism underlying clinical benefits. • First randomized, double-blind, placebo-controlled trial testing probiotic–acupotomology co-therapy for ischemic post-stroke dysphagia. • Adjunctive Bifidobacterium longum SX-1326 (2 g twice daily, 4 weeks) significantly enhanced improvements in WST, SSA, and SWAL-QOL. • Co-therapy improved nutritional recovery, reduced neuro-injury/inflammatory markers, and increased neurotrophic factors versus placebo. • Probiotic supplementation increased gut microbiota diversity and enriched beneficial genera (e.g., Bifidobacterium , Coprococcus , Collinsella ), with clinical–microbiome correlations. • Predicted functional shifts highlighted enhanced pyruvate-to-L-lactate fermentation, and the regimen was well tolerated with only mild, self-limiting adverse events.
Hu et al. (Sat,) studied this question.