Randomised, double-blind, placebo-controlled, parallel-group study to assess the efficacy and safety of antibiotic faecal microbiota transplantation in patients with Parkinson’s disease (FLORA-PD): a study protocol

📖 Top 20% JournalOct 21, 2025BMJ open

Antibiotic fecal microbiota transplant may help Parkinson's disease: study plan for a controlled trial

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Abstract

Thirty individuals with Parkinson's disease will participate in a study evaluating the efficacy and safety of a modified faecal microbiota transplantation approach.

Altered intestinal microbiota in people with Parkinson's disease may contribute to their symptoms.
Faecal microbiota transplantation has shown inconclusive results in improving motor symptoms in some pilot studies.
A modified approach involving pretreatment with antibiotics before faecal microbiota transplantation may enhance the effectiveness of the procedure.
This study will assess subjective and objective evaluations of symptoms at multiple time points, including 4 and 8 weeks post-treatment.
Exploratory endpoints will include analyses of blood and faecal samples, advanced brain imaging, and evaluation of levodopa concentrations.

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INTRODUCTION: The intestinal microbiota of people with Parkinson's disease (PwP) differs significantly from that of healthy individuals. Given that altered microbiota may play a role in the pathogenesis of Parkinson's disease, faecal microbiota transplantation (FMT) has been proposed as a potential therapeutic approach. However, the efficacy of FMT in improving motor symptoms in PwP has been inconclusive in some pilot randomised controlled trials (RCT). Previous RCTs on PwP employed simple FMT, but our modified approach-pretreatment with antibiotics before FMT (A-FMT)-has been shown to improve the engraftment rate of given species and the beneficial effects of FMT. This study aims to evaluate the efficacy and safety of A-FMT for PwP, particularly in those with motor fluctuations.

METHODS AND ANALYSIS: This study is a randomised, double-blind, placebo-controlled, parallel-group study with an 8-week observation period following a single A-FMT. Thirty clinically established PwP with prominent motor fluctuation episodes will be randomised 1:1 to FMT or placebo. Participants in both groups will receive antibiotic treatment prior to colonoscopy for FMT or placebo treatment. Primary and secondary endpoints will include subjective and objective evaluations of motor and non-motor symptoms and will be evaluated before and after antibiotic treatment and at 4 and 8 weeks after the procedure. Exploratory endpoints will include blood and faecal sample analyses, advanced brain MRI and pharmacokinetic assessment of levodopa concentrations during a levodopa challenge test.

ETHICS AND DISSEMINATION: This study has been approved by the ethical committee of Juntendo University in August 2024 (J24-005) and will be conducted in accordance with the Declaration of Helsinki, the Japan Ministry of Health, Labour and Welfare Clinical Trials Act and related laws and regulations. All patient data will be anonymised to protect privacy and used solely for study purposes. Results will be published in academic journals and presented at conferences.

TRIAL REGISTRATION NUMBER: jRCTs031240344.

Key numbers

Sample Size

Total number of participants randomized to or placebo group.

8 weeks

Follow-up Duration

Duration of observation after faecal microbiota transplantation.

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