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Background <p>Painful diabetic neuropathy (PDN) is a relatively common complication of diabetes. Experimental studies have shown that dysbiosis can act as a key factor in neural hypersensitivity and pain perception. We aim to assess the effect of synbiotics on PDN.</p> Materials and methods <p>In a randomized, double-blind clinical trial, 60 patients with painful diabetic neuropathy (PDN) were assigned to receive either a synbiotic (a 10<sup>9</sup> CFU blend of <i>Lactobacillus</i>, <i>Bifidobacterium</i>, and <i>Streptococcus</i> strains and 74&#xa0;mg of fructooligosaccharides) or a placebo for eight weeks.</p> Results <p>Compared to placebo, synbiotic significantly decreased the numerical rating score for pain (synbiotic: from 7.60 ± 0.85 to 3.20 ± 1.80; placebo: from 7.83 ± 0.95 to 6.43 ± 1.85; <i>P</i> &lt; 0.001), reduced sleep interference (synbiotic: from 6.83 ± 1.46 to 2.60 ± 1.69; placebo: from 6.83 ± 1.46 to 5.33 ± 2.64; <i>P</i> &lt; 0.001), and enhanced six out of eight domains of the 36-Item Short Form Health Survey questionnaire. Analysis of pain types in the short-form McGill Pain Questionnaire-2 showed significant improvements in hot-burning pain (<i>P</i> = 0.032), cold-freezing pain (<i>P</i> = 0.018), and tingling (<i>P</i> &lt; 0.001), whereas numbness and other investigated pain types did not show significant changes during the intervention period. Furthermore, body mass index, fasting blood insulin and glucose levels, and blood pressure did not change after intervention.</p> Conclusion <p>In conclusion, this study highlights the potential efficacy of synbiotic in alleviating pain and improving sleep and quality of life in patients with PDN. Trial registration: Iranian Registry of Clinical Trials (IRCT20090901002394N49), registered on 31 July 2023.</p>

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Effects of synbiotic supplementation on clinical symptoms and metabolic outcomes in patients with painful diabetic neuropathy: a pilot randomized controlled trial

  • 期刊论文

  • 出版模式：

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  • 发表日期：

    2026年8月5日

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  • Manoochehr Amin Amlashi,
  • Nahid Hashemi-Madani,
  • Shima Jazayeri

摘要

Background

Painful diabetic neuropathy (PDN) is a relatively common complication of diabetes. Experimental studies have shown that dysbiosis can act as a key factor in neural hypersensitivity and pain perception. We aim to assess the effect of synbiotics on PDN.

Materials and methods

In a randomized, double-blind clinical trial, 60 patients with painful diabetic neuropathy (PDN) were assigned to receive either a synbiotic (a 109 CFU blend of Lactobacillus, Bifidobacterium, and Streptococcus strains and 74 mg of fructooligosaccharides) or a placebo for eight weeks.

Results

Compared to placebo, synbiotic significantly decreased the numerical rating score for pain (synbiotic: from 7.60 ± 0.85 to 3.20 ± 1.80; placebo: from 7.83 ± 0.95 to 6.43 ± 1.85; P < 0.001), reduced sleep interference (synbiotic: from 6.83 ± 1.46 to 2.60 ± 1.69; placebo: from 6.83 ± 1.46 to 5.33 ± 2.64; P < 0.001), and enhanced six out of eight domains of the 36-Item Short Form Health Survey questionnaire. Analysis of pain types in the short-form McGill Pain Questionnaire-2 showed significant improvements in hot-burning pain (P = 0.032), cold-freezing pain (P = 0.018), and tingling (P < 0.001), whereas numbness and other investigated pain types did not show significant changes during the intervention period. Furthermore, body mass index, fasting blood insulin and glucose levels, and blood pressure did not change after intervention.

Conclusion

In conclusion, this study highlights the potential efficacy of synbiotic in alleviating pain and improving sleep and quality of life in patients with PDN. Trial registration: Iranian Registry of Clinical Trials (IRCT20090901002394N49), registered on 31 July 2023.