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REM Sleep Behavior DisorderNCT05353868

Gut Microbiota in the Progression of Alpha-synucleinopathies

An observational study of REM Sleep Behavior Disorder, run by Chinese University of Hong Kong at 1 site in Hong Kong.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial summary

The aim of this study is to correlate baseline gut microbiota features and the progression of neurodegeneration in the established cohort of patients with early Parkinson's disease. Read more about this study

Who is it for?
Any age
Conditions the study is for
REM Sleep Behavior Disorder
How many people
490 participants
Where
1 siteHong Kong
Study dates
1 Feb 2022to 30 Jun 2024
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages Any age
  • All sexes
  • No healthy volunteers
  • Child, Adult, Older adult

Study population: We will recruit from the subjects who completed the baseline study, which represent different stages of α-synucleinopathies, namely patients with PD (Braak's stages 3 or 4) without dementia, patients with iRBD (Braak's stage 2), first degree relatives of iRBD patients (iRBD-FDRs, Braak's stage 0 or 1), and healthy controls (Braak's stage 0).

Who may be able to join

  • recruit from the subjects who completed the baseline study

Who cannot join

  • The use of probiotics or antibiotics within three months prior to sample collection;
  • Pre-existing gastrointestinal diseases, such as inflammatory bowel disease.
  • Not capable of giving informed consent for participation of the study.

Trial locations and contacts

1 site in 1 country.

Hong Kong1 site, 1 recruiting
  • The Chinese University of Hong Kong

    Hong Kong

    Mandy Yu, MPH, 852-39197593, mandyyu@cuhk.edu.hk

    Rachel Chan, MPhil, 852-39197449, Rachel.chan@cuhk.edu.hk

    Recruiting

Other trials in Hong Kong

About this study

Official title: Gut Microbiota in the Progression of Alpha-synucleinopathies: a Prospective Follow-up Study

The aim of this study is to correlate baseline gut microbiota features and the progression of neurodegeneration in the established cohort of patients with early Parkinson's disease.

Read the detailed description

Alpha-synucleinopathy is a major group of neurodegenerative diseases that include Parkinson's disease and Dementia of Lewy bodies. They are known to have a long preclinical development, and prodromal markers that indicate the onset of early phase of the neurodegenerative process present along the way. Among the markers, idiopathic REM sleep behavior disorder (iRBD), a distinct form of parasomnia characterised by the presence of dream-enactment behaviour and REM sleep without atonia, represent a particularly high conversion likelihood that makes it a de facto precursor of clinical diseases (14 years conversion rate >95%). Thus, RBD serves as an exclusive opportunity for us to study the early-stage progression of α-synucleinpathies, and a window for early neuroprotective intervention.

In the context of α-synucleinopathic neurodegenerative diseases, high prevalence of gastrointestinal dysfunction and the presence of alpha-synuclein aggregates in the enteric nervous system at the early stage of disease have been found. These early findings were embedded in an influential Braak's hypothesis that the process of neurodegeneration can be started by 'unknown pathogen' from gut and spread to the central nervous system via vagus nerve in a caudal-rostral manner (medulla->pon->mid/forebrain->cortex). Human data showed that microbiome composition in patient with Parkinson's disease is different from control. The relative abundance of certain microbiotas, such as Enterobacteriaceae, have been shown to be associated with the severity of motor symptoms in patients with Parkinson's disease. It is hypothesized that microbiota dysbiosis resulting in a pro-inflammatory gut environment, which in turn create excessive oxidative stress and trigger alpha-synuclein misfolding cascade. While available evidence suggests that gut-brain hypothesis potentially plays a role in the disease process of α-synucleinopathies, the exact detail of microbiota involvement will need further examination. The key question of whether microbiota dysbiosis is driving or being driven by the process of neurodegeneration, need to be answered by prospective empirical studies that examine the longitudinal course of neurodegeneration from early to late stage, and to relate such course with the corresponding dynamic profile of the subjects' gut microbiota composition. Most of the available studies on this subject were cross-sectional studies that based on patients with Parkinson's disease, the terminal stage of the neurodegenerative process. There has been only two studies that include RBD patients, suggesting some alteration of microbiota happens in RBD stage already, but the number of RBD subjects included was small (n = 21 and 26), and there was no follow-up data (10, 11). In other words, there is no study that can answer such question at the moment. This remarkable gap in literature probably reflects two major obstacles researchers would face in planning such study: the difficulties in identifying and recruiting subjects with early-stage α-synucleinopathies, and the need for sufficient follow-up period to unfold the neurodegeneration process. In this regard, the investigators investigated gut microbiota composition in our established cohort of RBD and RBD family. Preliminary finding indicated gut dysbiosis has already occurred at or likely before the onset of RBD, at an even earlier stage of synucleinopathy (i.e., high-risk relatives of RBD). For example, consistent overabundance of Ruminococcaceae UCG-002 were found in RBD relatives, patient with RBD and early PD, as compared with controls.

In this study, the investigators will perform 3-year follow-up of clinical assessments and gut microbiota measurement. The investigators aim to correlate baseline gut microbiota features and the progression of neurodegeneration, e.g., emerged autonomic dysfunctions, phenoconversion, in the established cohort of patients with early Parkinson's disease, idiopathic RBD, first-degree relatives (FDRs) of patients with iRBD and healthy controls. Besides, the investigator will examine the associations between long-term gut microbiota changes and progression of neurodegenerative biomarkers and compare the long-term changes of gut microbiota between controls and different early stages of α-synucleinopathies.

Being tested
No intervention
Keywords
Gut microbiota, Parkinson's disease, REM sleep behavior disorder
Medical subject headings
REM Sleep Behavior Disorder, Parkinson Disease

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • No interventionOther

    No intervention

Study groups in NCT05353868
Study groupRoleWhat they receive
Early PD1. Recruited in the baseline study as a subject of the Early PD group 2. Completed baseline assessment and stool sample collection 3. Being capable of giving informed consent for participation of the study
Receives: Other: No intervention
iRBD1. Recruited in the baseline study as a subject of the iRBD group 2. Completed baseline assessment and stool sample collection 3. Being capable of giving informed consent for participation of the study
Receives: Other: No intervention
First degree relatives of patient with iRBD1. Recruited in the baseline study as a subject of the 'First degree relatives of patients with iRBD' group 2. Completed baseline assessment and stool sample collection 3. Not cohabiting with iRBD proband
Receives: Other: No intervention
Health control1. Recruited in the baseline study as a subject of the 'healthy controls' group 2. Completed baseline assessment and stool sample collection 3. Being capable of giving informed consent for participation of the study
Receives: Other: No intervention

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Composition of gut microbiota

    Correlation of baseline gut microbiota features and the progression of α-synucleinopathy neurodegeneration.

    Measured: 2 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted29 Apr 2022
  2. Study start1 Feb 2022
  3. Primary completion30 Jun 2024 (estimated)
  4. Study completion30 Jun 2024 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Prospective
Enrolment
490 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05353868
Sponsor's protocol ID
NTEC-2021-0614
Status last verified
Apr 2024
First submitted
13 Jan 2022
Last updated
19 Apr 2024
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided: Data will be handled and stored under Department of Psychiatry and PI will be responsible for the safekeeping.

Questions about this trial

What is this clinical trial studying?

An observational study of REM Sleep Behavior Disorder, run by Chinese University of Hong Kong at 1 site in Hong Kong.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 1 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 19 Apr 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Hong Kong. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Composition of gut microbiota (time frame: 2 years). It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Apr 2024.

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