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

Por: Takeshige-Amano · H. · Igami · E. · Okuzumi · A. · Kamo · R. · Iseki · M. · Tsuyama · K. · Wakamori · R. · Okada · H. · Taniguchi · D. · Ueno · S.-I. · Oji · Y. · Ishikawa · K.-i. · Nishikawa · N. · Orikasa · M. · Odakura · R. · Koma · M. · Maruyama · T. · Nomura · K. · Ishikawa · D. · Shibu
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.

Psychosocial factors and patient experience associated with diabetes treatment discontinuation: a cross-sectional study in Japan

Por: Kuwabara · Y. · Taniguchi · S.-I. · Hosoda-Urban · T. · Son · D. · Kinjo · A. · Kim · H. · Kaneda · Y. · Osaki · Y.
Objectives

The prevention of treatment discontinuation is crucial in mitigating the adverse consequences of diabetes. This study aimed to identify the psychosocial factors and patient experiences associated with the discontinuation of diabetes treatment.

Design

A cross-sectional study was conducted.

Setting

A nationwide online survey with convenience sampling.

Participants

Participants, aged 40–79 years, who reported living with diabetes, were included.

Primary and secondary outcome measures

Treatment continuation status was the outcome variable. Participants who previously received regular treatment but were not currently under medical care were classified as the treatment discontinuation group. Psychological factors (mood and anxiety disorders, self-esteem, procrastination), social factors (loneliness, economic difficulties, adverse childhood experiences) and patient experiences and opinions regarding diabetes were assessed.

Results

A total of 4715 individuals were included in the analysis. After adjusting for confounders, psychological distress (adjusted OR (AOR)=1.87, 95% CI (1.06 to 3.30), p=0.032) and higher procrastination (AOR=2.64, 95% CI (1.25 to 5.56), p=0.011) were significantly associated with treatment discontinuation. Overall, 9.7% of participants reported financial hardship, and 12.1% reported diabetes burnout during their course of treatment. Financial hardships (p=0.002), difficulty with child or older adult care (p

Conclusions

Psychological distress and higher procrastination levels were significantly associated with diabetes treatment discontinuation, after adjusting for potential confounders. The treatment discontinuation group reported significantly more psychosocial challenges than the continuation group. Healthcare providers and systems should prioritise addressing the psychosocial characteristics, experiences and challenges faced by individuals with diabetes.

Coverage rates and reasons for pneumococcal vaccination among adults with chronic medical conditions and the elderly in Japan: a web-based, cross-sectional study

Por: Kim · Y. · Taniguchi · H. · Okuyama · K. · Kawakami · K.
Objectives

The 23-valent pneumococcal polysaccharide vaccine (PPSV23) is included in the routine immunisation programme for adults aged 65 years and those aged 60–64 years with serious chronic medical conditions (CMCs). To improve the vaccination coverage rates, a catch-up subsidy programme was implemented by the Japanese government from October 2014 to March 2024, which resulted in no improvement in the coverage rates. For further facilitation of pneumococcal vaccination, research is warranted to understand public attitudes toward pneumococcal vaccination by assessing coverage rates and reasons for vaccination among not only the subsidy-eligible population but also in individuals aged 19–64 years with CMCs who self-pay for pneumococcal vaccination.

Design

Nationwide, cross-sectional survey.

Setting

A web-based questionnaire study using a validated consumer panel in Japan.

Participants

Japanese adults aged 19–64 years with CMCs and those aged ≥65 years registered in the consumer panel as of March 2023.

Primary and secondary outcome measures

Vaccine coverage rates, reasons for receiving or not receiving the vaccination, willingness of unvaccinated individuals to receive the vaccine in the future under the current vaccination programme and factors associated with pneumococcal vaccination coverage rates.

Results

Vaccination coverage rates were 12.4% in those aged 19–49 years, 3.2% in those aged 50–59 years and 4.0% in those aged 60–64 years with CMCs and 55.1% in those aged ≥65 years (61.6% and 52.9% in those with and without CMCs, respectively). The majority (89.1%) of unvaccinated participants aged 19–64 years with CMCs had a positive or neutral attitude towards receiving future pneumococcal vaccinations. Among vaccinated individuals, 79.0% of those aged 19–64 years with CMCs and 56.0% of those aged ≥65 years reported that they had received a doctor’s recommendation. Doctors’ recommendation was the most common reason for receiving the vaccine among participants aged 19–64 years with CMCs (35.1%), whereas notification from the municipality was the most important reason among those aged ≥65 years (46.1%).

Conclusions

Data from this study suggest that recommendations from doctors are crucial for increasing coverage rates of pneumococcal vaccines, particularly among adults aged 19–64 years with CMCs. The majority of unvaccinated participants in this group had a positive or neutral attitude towards future vaccination, highlighting the importance of strong recommendations by doctors.

Trial registration number

jRCT1030220606.

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