Introduction: Some studies have found that probiotics have the potential totreat PD, and earthworm protein is a traditional Chinese medicine used forthe treatment of PD. The purpose of this study was to evaluate the safety andefficacy of Bacteroides fragilis 839 (BF839) + earthworm protein supplement asan adjunctive therapy for PD and to observe changes in the gut microbiota.
Methods: Forty-six patients with PD were recruited for a 12-week 1:1randomized, double-blind, placebo-controlled clinical trial to evaluatechanges in motor and some non-motor symptom scores and detectmetagenomic changes in the gut microbiota.
Results: From baseline to 12 weeks, compared with placebo, the trial groupshowed 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 partI (−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), andUPDRS part IV (−1.13 ± 1.19 vs. –0.15 ± 0.57, p = 0.001). Significant reductions inthe 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), andConstipation scoring system scores (−8.59 ± 4.75 vs. 0.27 ± 1.24, p < 0.001), werealso noted. In the trial group, one patient experienced mild eczema and onesuffered low blood pressure, which could not be conclusively attributed tosupplementation. Compared to the placebo group, the trial group showed amarked increase in Enterococcus faecium and a decrease in Klebsiella.
Conclusion: This study is the first to report that probiotics plus earthwormprotein can remarkably improve the motor and some non-motor symptomsof PD without serious adverse effects. However, further clinical trials andexploration of the underlying mechanisms are required.
Clinical trial registration: Clinical trial registry http://www.chictr.org.cn/,Identification No: ChiCTR2000035122.
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