Gut Microbiota and Parkinson's Disease
1 other identifier
observational
50
0 countries
N/A
Brief Summary
Over the past decade, experimental data has suggested a complex and bidirectional interaction between the gastrointestinal (GI) tract and the central nervous system (CNS), the so-called "Gut- Brain axis." . Changes in the gut microbiota composition may cause alterations in the gut barrier function and intestinal permeability, affecting not only GI epithelial cells and immune system, but also the ENS including both neurons and glial cells . The bidirectional brain-gut-microbiota axis interactions modulate pro- and anti-inflammatory responses. It has been suggested that the gut microbiota changes associated with intestinal inflammation may contribute to the initiation of α-syn misfolding. There is a growing number of evidence confirming that the gut microbiota alterations precede or occur during the course of PD. Importantly, some genetic risk factors may play a crucial role in the interactions between the brain-gut-microbiota axis with respect to gut inflammation. It has been also shown that the methylation status in the SNCA promoter region may affect α-syn expression and the risk for PD. Therefore, a potential role of the gut microbiota as an epigenetic factor influencing DNA methylation may be speculated. Moreover, genetic variant of the component of innate immune system - TREM2 (Triggering Receptor Expressed on Myeloid cells) has been reported to be associated with a higher risk for PD. The ε4 allele of apolipoprotein E (ApoE) has been shown to increase the risk for dementia in synucleinopathies such as PD. Potentially, ApoE genotype, by influencing bile acid secretion, could affect the composition of the gut microbiota to favor the development of organisms triggering misfolding. Moreover, three single nucleotide polymorphisms in CARD15 gene, known to be associated with Crohn's disease, have been also shown to be over-expressed in PD patients, supporting the observation that GI inflammation contributes to the pathogenesis of PD.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for all trials
Started Jan 2019
Typical duration for all trials
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
October 8, 2018
CompletedFirst Posted
Study publicly available on registry
October 18, 2018
CompletedStudy Start
First participant enrolled
January 1, 2019
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 1, 2020
CompletedStudy Completion
Last participant's last visit for all outcomes
December 31, 2021
CompletedOctober 18, 2018
October 1, 2018
1 year
October 8, 2018
October 16, 2018
Conditions
Outcome Measures
Primary Outcomes (1)
Effect of gut microbiota on pathogenesis of Parkinson's diseases
the QIAamp DNA Stool mini kit to extract total bactria DNA Some genetic risk factors may play a crucial role in the interactions between the brain-gut-microbiota axis with respect to gut inflammation. It has been also shown that the methylation status in the SNCA promoter region may affect α-syn expression and the risk for PD
1 year
Interventions
MRI brain if indicated
Eligibility Criteria
Unified Parkinson's Disease Rating Scale (UPDRS) and the modified Hoehn \& Yahr Scale (H\&Y). Non-Motor Symptoms Scale (NMSS). Demographic and clinical data (Age, sex, age of onset, severity of disease, clinical symptoms and signs, Types of treatment, duration of treatment, number of attacks)
You may qualify if:
- (50) patients diagnosed with Parkinson's Disease .
- (50) Control group free from Disease .
You may not qualify if:
- prior surgeries.
- any patients or controls currently taking antibiotics or probiotic supplements.
- having a known history of disease with an disease such, autoimmune disorders , cardiac patients
- history of stroke ,rheumatoid arthritis, type-1-diabetes, and IBD .
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Alaa E Ahmedlead
Biospecimen
Stool Sample
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- observational
- Observational Model
- CASE CONTROL
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR INVESTIGATOR
- PI Title
- Doctor
Study Record Dates
First Submitted
October 8, 2018
First Posted
October 18, 2018
Study Start
January 1, 2019
Primary Completion
January 1, 2020
Study Completion
December 31, 2021
Last Updated
October 18, 2018
Record last verified: 2018-10