{
  "abstract": "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.",
  "authors": [
    {
      "affiliations": [
        "Department of Neurology, Juntendo University Faculty of Medicine, Tokyo, Japan"
      ],
      "name": "Haruka Takeshige-Amano"
    },
    {
      "affiliations": [
        "Department of Neurology, Juntendo University Faculty of Medicine, Tokyo, Japan"
      ],
      "name": "Eriko Igami"
    },
    {
      "affiliations": [
        "Department of Neurology, Juntendo University Faculty of Medicine, Tokyo, Japan"
      ],
      "name": "Ayami Okuzumi"
    },
    {
      "affiliations": [
        "Department of Neurology, Juntendo University Faculty of Medicine, Tokyo, Japan"
      ],
      "name": "Ryota Kamo"
    },
    {
      "affiliations": [
        "Department of Neurology, Juntendo University Faculty of Medicine, Tokyo, Japan"
      ],
      "name": "Mariko Iseki"
    },
    {
      "affiliations": [
        "Department of Neurology, Juntendo University Faculty of Medicine, Tokyo, Japan"
      ],
      "name": "Kou Tsuyama"
    },
    {
      "affiliations": [
        "Department of Neurology, Juntendo University Faculty of Medicine, Tokyo, Japan"
      ],
      "name": "Ryo Wakamori"
    },
    {
      "affiliations": [
        "Department of Neurology, Juntendo University Faculty of Medicine, Tokyo, Japan"
      ],
      "name": "Hanna Okada"
    },
    {
      "affiliations": [
        "Department of Neurology, Juntendo University Faculty of Medicine, Tokyo, Japan"
      ],
      "name": "Daisuke Taniguchi"
    },
    {
      "affiliations": [
        "Department of Neurology, Juntendo University Faculty of Medicine, Tokyo, Japan"
      ],
      "name": "Shin-Ichi Ueno"
    },
    {
      "affiliations": [
        "Department of Neurology, Juntendo University Faculty of Medicine, Tokyo, Japan"
      ],
      "name": "Yutaka Oji"
    },
    {
      "affiliations": [
        "Department of Neurology, Juntendo University Faculty of Medicine, Tokyo, Japan"
      ],
      "name": "Kei-ichi Ishikawa"
    },
    {
      "affiliations": [
        "Department of Neurology, Juntendo University Faculty of Medicine, Tokyo, Japan"
      ],
      "name": "Noriko Nishikawa"
    },
    {
      "affiliations": [
        "Department of Gastroenterology, Juntendo University Faculty of Medicine, Tokyo, Japan",
        "Innovative Microbiome Therapy Research Center, Juntendo University Graduate School of Medicine, Tokyo, Japan"
      ],
      "name": "Masayuki Orikasa"
    },
    {
      "affiliations": [
        "Department of Gastroenterology, Juntendo University Faculty of Medicine, Tokyo, Japan",
        "Innovative Microbiome Therapy Research Center, Juntendo University Graduate School of Medicine, Tokyo, Japan"
      ],
      "name": "Rina Odakura"
    },
    {
      "affiliations": [
        "Department of Gastroenterology, Juntendo University Faculty of Medicine, Tokyo, Japan",
        "Innovative Microbiome Therapy Research Center, Juntendo University Graduate School of Medicine, Tokyo, Japan"
      ],
      "name": "Masao Koma"
    },
    {
      "affiliations": [
        "Department of Gastroenterology, Juntendo University Faculty of Medicine, Tokyo, Japan",
        "Innovative Microbiome Therapy Research Center, Juntendo University Graduate School of Medicine, Tokyo, Japan"
      ],
      "name": "Takafumi Maruyama"
    },
    {
      "affiliations": [
        "Department of Gastroenterology, Juntendo University Faculty of Medicine, Tokyo, Japan",
        "Innovative Microbiome Therapy Research Center, Juntendo University Graduate School of Medicine, Tokyo, Japan"
      ],
      "name": "Kei Nomura"
    },
    {
      "affiliations": [
        "Department of Gastroenterology, Juntendo University Faculty of Medicine, Tokyo, Japan",
        "Innovative Microbiome Therapy Research Center, Juntendo University Graduate School of Medicine, Tokyo, Japan",
        "Department of Pathophysiological Research and Therapeutics for Gastrointestinal Diseases, Juntendo University Graduate School of Medicine, Tokyo, Japan",
        "Metagen Therapeutics Inc, Tsuruoka, Japan"
      ],
      "name": "Dai Ishikawa"
    },
    {
      "affiliations": [
        "Department of Gastroenterology, Juntendo University Faculty of Medicine, Tokyo, Japan",
        "Department of Pathophysiological Research and Therapeutics for Gastrointestinal Diseases, Juntendo University Graduate School of Medicine, Tokyo, Japan"
      ],
      "name": "Tomoyoshi Shibuya"
    },
    {
      "affiliations": [
        "Department of Gastroenterology, Juntendo University Faculty of Medicine, Tokyo, Japan",
        "Innovative Microbiome Therapy Research Center, Juntendo University Graduate School of Medicine, Tokyo, Japan",
        "Department of Pathophysiological Research and Therapeutics for Gastrointestinal Diseases, Juntendo University Graduate School of Medicine, Tokyo, Japan"
      ],
      "name": "Akihito Nagahara"
    },
    {
      "affiliations": [
        "Metagen Therapeutics Inc, Tsuruoka, Japan"
      ],
      "name": "Hideyuki Teramoto"
    },
    {
      "affiliations": [
        "Medical Technology Innovation Center, Juntendo University, Tokyo, Japan"
      ],
      "name": "Naotake Yanagisawa"
    },
    {
      "affiliations": [
        "Department of Neurology, Juntendo University Faculty of Medicine, Tokyo, Japan"
      ],
      "name": "Taku Hatano"
    },
    {
      "affiliations": [
        "Department of Neurology, Juntendo University Faculty of Medicine, Tokyo, Japan",
        "Neurodegenerative Disorders Collaboration Laboratory, Riken Center for Brain Science, Wako, Japan"
      ],
      "name": "Nobutaka Hattori"
    }
  ],
  "title": "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",
  "uid": "d35bacf5-8ca3-5ea7-acc8-ae990fd5f25d"
}