Helicobacter pylori Eradication in Parkinson's Disease: A Randomized Placebo‐Controlled Trial

Abstract

A BS TRACT: Background: Helicobacter pylori (HP) infection has been associated with worse motor function in Parkinson's disease (PD). Objective: We aimed to evaluate the effects of HP eradication on PD symptoms. Methods: In this parallel-group, double-blind, randomized placebo-controlled, single-center trial, patients with PD with positive HP urea breath test and serology were block randomized (1:1) to receive standard eradication triple therapy or identically appearing placebo capsules for 1 week. Prespecified motor (International Parkinson and Movement Disorder Society Unified PD Rating Scale [MDS-UPDRS], timed tests, and home-based wearable sensor measurements), nonmotor (Leeds Dyspepsia Questionnaire and Montreal Cognitive Assessment), and quality-of-life (Parkinson's Disease Questionnaire-39) outcome measures were assessed at weeks 6, 12, 24, and 52. The primary outcome was the baseline-to-week 12 change in ON medication MDS-UPDRS motor scores. Lactulose-hydrogen breath testing for concomitant small intestinal bacterial overgrowth was performed at baseline and repeated at week 24, together with the urea breath test. Results: A total of 310 patients were screened for eligibility and 80 were randomly assigned, of whom 67 were included in the full-analysis set (32 treatment group patients, 35 placebo patients). HP eradication did not improve MDS-UPDRS motor scores at week 12 (mean difference 2.6 points in favor of placebo, 95% confidence interval: −0.4 to 5.6, P = 0.089). There was no significant improvement in any motor, nonmotor, or quality-of-life outcome at weeks 12 and 52. Both the full-analysis and per-protocol analyses (based on eradication status) supported these conclusions. Small intestinal bacterial overgrowth status did not influence treatment results. Conclusions: HP eradication does not improve clinical outcomes in PD, suggesting that there is no justification for routine HP screening or eradication with the goal of improving PD symptoms.

Gut Microbial Ecosystem in Parkinson Disease: New Clinicobiological Insights from Multi‐Omics

“…The associations with PD features further highlight the clinical relevance of gut metabolite changes in PD. However, many knowledge gaps remain, and mechanistic experimental models, 31 longitudinal research, and human interventional studies 76,77 targeting specific microbial/metabolic features will be needed to unravel how they contribute to physiological functions and pathological outcomes in patients.…”

The gut-brain axis and Parkinson disease: clinical and pathogenetic relevance

“…Interestingly, the latter study evaluated the role of concomitant SIBO, finding no significant improvement in motor outcomes after HP eradication in those patients who were SIBO negative at baseline, while conversion to SIBO negativity did not improve motor function in initially SIBO-positive patients [107]. Overall, these results seem to argue against the hypothesis that SIBO may play a concomitant role with HP infection in determining motor function in PD [107].…”

“…In one of these studies, clinical improvement was coupled with significant increased levodopa absorption following HP eradication [99]. However, a recent single-center RCT conducted on 67 PD patients showed no improvement of motor outcomes after 12 weeks, and no changes in non-motor symptoms and quality of life at week 12 and 52 [107]. Interestingly, the latter study evaluated the role of concomitant SIBO, finding no significant improvement in motor outcomes after HP eradication in those patients who were SIBO negative at baseline, while conversion to SIBO negativity did not improve motor function in initially SIBO-positive patients [107].…”

Review: The Role of Intestinal Dysbiosis in Parkinson’s Disease

“…Besides, H. pylori eradication not only extended ON duration but also improved the levodopa onset time and quality of life parameters (Hashim et al, 2014). However, a recent study has shown that H. pylori eradication did not improve the MDS-UPDRS scores of PD patients significantly, whether it is part of motor, nonmotor or quality of life outcome (Tan et al, 2020). More well-designed trials are needed to verify the effect of H. pylori eradication in PD.…”