Date Submitted: Jun 16, 2025. Open Peer Review Period: Jun 16, 2025 - Aug 11, 2025.

Background: Parkinson disease (PD), a prevalent neurodegenerative disorder characterized by motor and nonmotor symptoms, is becoming increasingly prevalent worldwide. Conventional treatment for PD involves dopamine therapy, including levodopa; however, this treatment is ineffective for nonmotor symptoms and may cause adverse effects. The gut-brain axis has been hypothesized to promote PD, and regulation of gut microbiome, which modulates the gut-brain axis, is emerging as a treatment target. Acupuncture and moxibustion exert therapeutic effects on PD and modulate the gut microbial composition. Objective: We present a #Protocol for analyzing the effects of acupuncture and moxibustion on gut microbiome and exploring its association with symptoms in patients with PD. Methods: This single-group, prospective, observational #Study will recruit 60 patients with idiopathic PD and 20 healthy participants. Baseline gut microbiome patterns and motor and nonmotor symptoms of both groups will be compared. Patients with PD will be treated with acupuncture, moxibustion, and intradermal acupuncture twice a week for 12 weeks (24 sessions total). Motor and nonmotor symptoms and gut microbiome changes in patients with PD will be compared before starting treatment (day 0), during treatment (6 weeks), at the end of treatment (12 weeks), and 2 months after the end of treatment (20 weeks). The correlation between motor and nonmotor symptoms of PD changed by acupuncture and moxibustion treatment and changes in gut microbiome will be analyzed. Healthy participants will be assessed for motor and nonmotor symptoms of PD and gut microbiome after screening. Results: This #Study was supported by the National #Research Foundation of Korea, funded by the Ministry of Science and ICT (Information and Communication Technology), Republic of Korea, and recruitment for the #Study started on October 21, 2021. As of February 19, 2025, recruitment and observation ended, and data analysis is being conducted. Conclusions: This is the first clinical #Study to assess the effects of acupuncture and moxibustion on gut microbiome and explore its association with symptoms in patients with PD. The results will provide clinical evidence to explain the microbiome-gut-brain axis mechanism of acupuncture and moxibustion for PD and suggest the possibility of acupuncture as an alternative therapy for PD. Trial Registration: Clinical #Research Information Service KCT0006669; https://tinyurl.com/42jsxs5a

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