Effects of synbiotic supplementation on clinical symptoms and metabolic outcomes in patients with painful diabetic neuropathy: a pilot randomized controlled trial.
4 affiliations
- 1Department of Nutrition, School of Public Health, Iran University of Medical Sciences, Shahid Hemmat Highway, 1449614535, Tehran, Islamic Republic of Iran.
- 2Endocrine Research Center, Institute of Endocrinology and Metabolism, Iran University of Medical Sciences, Tehran, Iran.
- 3Department of Nutrition, School of Public Health, Iran University of Medical Sciences, Shahid Hemmat Highway, 1449614535, Tehran, Islamic Republic of Iran. [email protected].
- 4Nutritional Sciences Research Center, Iran University of Medical Sciences, Tehran, Iran. [email protected].
Abstract
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.
Related
- Effect of vitamin D supplementation on metabolic syndrome parameters in adults: a systematic review of randomized controlled trials exploring the role of baseline vitamin D status and supplementation dose
- A Synbiotic Infant Formula Promotes Balanced Immune-Microbiome Interactions in Term Infants: A Randomized Controlled Trial
- Topical herbal medicine as treatment for chemotherapy-induced peripheral neuropathy: a systematic review of randomized controlled trials
- Vitamin D screening and targeted supplementation delays liver fibrosis in patients with chronic liver disease: A prospective randomized controlled trial
- Synbiotic HQP08 Supplementation for Hair Loss and Depressive Symptoms: An Open-Label Pilot Study of Clinical Outcomes and Gut Microbiome Changes
BibTeX
@article{amlashi2026effects,
title = {{Effects of synbiotic supplementation on clinical symptoms and metabolic outcomes in patients with painful diabetic neuropathy: a pilot randomized controlled trial.}},
author = {Manoochehr Amin Amlashi and Nahid Hashemi-Madani and Shima Jazayeri},
journal = {Diabetology \& metabolic syndrome},
year = {2026},
month = aug,
doi = {10.1186/s13098-026-02244-7},
url = {https://europepmc.org/article/MED/42972388},
note = {CC BY-NC-ND},
}
RIS
TY - JOUR
TI - Effects of synbiotic supplementation on clinical symptoms and metabolic outcomes in patients with painful diabetic neuropathy: a pilot randomized controlled trial.
AU - Manoochehr Amin Amlashi
AU - Nahid Hashemi-Madani
AU - Shima Jazayeri
PY - 2026
DA - 2026/08/05
JO - Diabetology & metabolic syndrome
DO - 10.1186/s13098-026-02244-7
UR - https://europepmc.org/article/MED/42972388
AB - 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.
SN - 1758-5996
ER -