With your risk of Parkinsons post stroke, your competent? doctor and hospital should be ensuring that they know which intervention is better for Parkinsons. Or don't you have a competent doctor or hospital?
This one or the newest one?Trial of Lixisenatide in Early Parkinson’s Disease April 2024
Do you prefer your doctor and hospital incompetence NOT KNOWING? OR NOT DOING?
Parkinson’s Disease May Have Link to Stroke March 2017
The latest here:
Safety and efficacy of faecal microbiota transplantation in patients with mild to moderate Parkinson's disease (GUT-PARFECT): a double-blind, placebo-controlled, randomised, phase 2 trial
- et al.
Summary
Background
Dysregulation
of the gut microbiome has been implicated in Parkinson's disease (PD).
This study aimed to evaluate the clinical effects and safety of a single
faecal microbiota transplantation (FMT) in patients with early-stage
PD.
Methods
The GUT-PARFECT
trial, a single-centre randomised, double-blind, placebo-controlled
trial was conducted at Ghent University Hospital between December 01,
2020 and December 12, 2022. Participants (aged 50–65 years, Hoehn and
Yahr stage 2) were randomly assigned to receive nasojejunal FMT with
either healthy donor stool or their own stool. Computer-generated
randomisation was done in a 1:1 ratio through permutated-block
scheduling. Treatment allocation was concealed for participants and
investigators. The primary outcome measure at 12 months was the change
in the Movement Disorders Society-Unified Parkinson's Disease Rating
Scale (MDS-UPDRS) motor score obtained during off-medication
evaluations. Intention-to-treat analysis was performed using a mixed
model for repeated measures analysis. This completed trial is registered
on ClinicalTrials.gov (NCT03808389).
Findings
Between
December 2020 and December 2021, FMT procedures were conducted on 46
patients with PD: 22 in the healthy donor group and 24 in the placebo
group. Clinical evaluations were performed at baseline, 3, 6, and 12
months post-FMT. Full data analysis was possible for 21 participants in
the healthy donor group and 22 in the placebo group. After 12 months,
the MDS-UPDRS motor score significantly improved by a mean of 5.8 points
(95% CI −11.4 to −0.2) in the healthy donor group and by 2.7 points
(−8.3 to 2.9) in the placebo group (p = 0.0235). Adverse events were
limited to temporary abdominal discomfort.
Interpretation
Our
findings suggested a single FMT induced mild, but long-lasting
beneficial effects on motor symptoms in patients with early-stage PD.
These findings highlight the potential of modulating the gut microbiome
as a therapeutic approach and warrant a further exploration of FMT in
larger cohorts of patients with PD in various disease stages.
Funding
Flemish PD patient organizations (VPL and Parkili), Research Foundation Flanders (FWO), Biocodex Microbiota Foundation.
Keywords
Research in context
Evidence before this study
A
comprehensive search was conducted on PubMed from database inception
till September 1st, 2023, using the search terms “Parkinson” and “gut
microbiota” or “gut microbiome”, without any language or date
restrictions. The existing literature supports an early involvement of
the gastrointestinal system in the aetiology and progression of
Parkinson's disease (PD) for a sub-group of patients, supporting the
gut-first versus brain-first hypothesis. During the prodromal phase of
the disease, evidence suggests the presence of alpha-synuclein in the
enteric nervous system, subclinical gut inflammation, compromised
intestinal barrier integrity, and gastrointestinal symptoms like
constipation. Several recent meta-analyses comparing the gut microbiota
of patients with PD to healthy controls have shown differential
abundances of taxa associated with reduced mucosal barrier and increased
intestinal inflammation. An additional search was performed on PubMed
using the terms “Parkinson” and “microbiota transplantation” which
yielded 82 reports predominantly focusing on faecal microbiota
transplantation (FMT) as a potential treatment for PD. Four open-label
studies with small number of patients have demonstrated beneficial
effects on symptoms, mainly constipation. Although technically not a FMT
study, a recently conducted pilot study with a randomized and
placebo-controlled design (n = 11), using an orally lyophilised donor
stool product or matching placebo, was well tolerated and reported
reduced constipation, however objective UPDRS motor improvements were
transient and not statistically different from placebo. In these
studies, adverse events associated with FMT were mild and restricted to
transient gastro-intestinal discomfort and diarrhoea.
Added value of this study
We
present the results of a one-year, randomized, double-blind,
placebo-controlled study of nasojejunal FMT in patients with early-stage
PD. This study is the first of its kind with larger sample sizes
compared to previously reported trials. The healthy donor FMT group
demonstrated significantly greater improvements in motor symptom
severity compared to the control group, with the effect becoming more
pronounced starting from the 6 to 12 months interval. Objective
measurements of gastrointestinal transit indicated improvements in the
healthy donor group, starting from the 3 to 6 months interval. No severe
adverse events were reported in either group, further supporting the
safety profile of FMT.
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