Gut Microbiota in the Progression of Alpha-synucleinopathies

NCT05353868 | Recruiting DMC

• 1 other identifier: NTEC-2021-0614
• Study Type: observational
• Target: 490
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

REM Sleep Behavior Disorder

Keywords

Gut microbiota; Parkinson's disease; REM sleep behavior disorder

Outcome Measures

Primary Outcomes (1)

• Composition of gut microbiota

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

  2 years

Study Arms (4)

Early PD

1. 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

Other: No intervention

iRBD

1. 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

Other: No intervention

First degree relatives of patient with iRBD

1. 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

Other: No intervention

Health control

1. 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

Other: No intervention

Interventions

No intervention OTHER

No intervention

Early PD; First degree relatives of patient with iRBD; Health control; iRBD

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

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).

You may qualify if:

• recruit from the subjects who completed the baseline study

You may not qualify if:

• 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.

Sponsors & Collaborators

• Chinese University of Hong Kong: lead

Study Sites (1)

The Chinese University of Hong Kong

Hong Kong, Hong Kong

RECRUITING

MeSH Terms

Conditions

REM Sleep Behavior Disorder; Parkinson Disease

Condition Hierarchy (Ancestors)

REM Sleep Parasomnias; Parasomnias; Sleep Wake Disorders; Nervous System Diseases; Mental Disorders; Parkinsonian Disorders; Basal Ganglia Diseases; Brain Diseases; Central Nervous System Diseases; Movement Disorders; Synucleinopathies; Neurodegenerative Diseases

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: January 13, 2022
• First Posted: April 29, 2022
• Study Start: February 1, 2022
• Primary Completion: June 30, 2024
• Study Completion: June 30, 2024
• Last Updated: April 19, 2024

Record last verified: 2024-04

Locations

HK (1)