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CLINICAL TRIAL article
Front. Neurol.
Sec. Dementia and Neurodegenerative Diseases
Volume 15 - 2024 |
doi: 10.3389/fneur.2024.1371791
Effect of BF839 + Earthworm Protein Supplement on Motor and some Non-Motor Symptoms of Parkinson's Disease: A Randomized Clinical Trial
Provisionally accepted- The Second Affiliated Hospital of Guangzhou Medical University, Guangzhou, Guangdong Province, China
Introduction: Some studies have found that probiotics have the potential to treat PD, and earthworm protein is a traditional Chinese medicine used for the treatment of PD. The purpose of this study was to evaluate the safety and efficacy of Bacteroides fragilis 839(BF839) + earthworm protein supplement as an adjunctive therapy for PD and to observe changes in the gut microbiota. Methods: Forty-six patients with PD were recruited for a 12-week 1:1 randomized, double-blind, placebo-controlled clinical trial to evaluate changes in motor and some non-motor symptom scores and detect metagenomic changes in the gut microbiota. Results: From baseline to 12 weeks, compared with placebo, the trial group showed significant reductions in the United Parkinson's Disease Rate Scale (UPDRS) total score (-7.74±5.92 vs. -1.83±4.14, P<0.001), UPDRS part I (-0.72±0.81 vs. -0.20±0.72, P=0.026), UPDRS part II (-2.50±2.24 vs. -0.22±1.98, P=0.001), UPDRS part III (-3.43±3.42 vs. -1.33±2.65, P=0.024), and UPDRS part IV (-1.13±1.19 vs. -0.15±0.57, P=0.001). Significant reductions in the Hamilton Depression Scale-24 score (-3.91±3.99 vs. +1.15±3.42, P<0.001), Self-Rating Anxiety Scale scores (-7.04±5.71 vs. -1.23±2.34, P<0.001), and Constipation scoring system scores (-8.59±4.75 vs. 0.27±1.24, P<0.001), were also noted. In the trial group, one patient experienced mild eczema and one suffered low blood pressure, which could not be conclusively attributed to supplementation. Compared to the placebo group, the trial group showed a marked increase in Enterococcus faecium and a decrease in Klebsiella. Conclusion: This study is the first to report that probiotics plus earthworm protein can remarkably improve the motor and some non-motor symptoms of PD without serious adverse effects. However, further clinical trials and exploration of the underlying mechanisms are required.
Keywords: Bacteroides fragilis 839, Earthworm, Gut Microbiota, Parkinson's disease, Probiotics
Received: 17 Jan 2024; Accepted: 26 Aug 2024.
Copyright: © 2024 Zeng, Lin, Deng and Zhu. This is an open-access article distributed under the terms of the Creative Commons Attribution License (CC BY). The use, distribution or reproduction in other forums is permitted, provided the original author(s) or licensor are credited and that the original publication in this journal is cited, in accordance with accepted academic practice. No use, distribution or reproduction is permitted which does not comply with these terms.
* Correspondence:
Weiwen Zhu, The Second Affiliated Hospital of Guangzhou Medical University, Guangzhou, 510260, Guangdong Province, China
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