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Effects of Probiotics on Peripheral Immunity in Parkinson's Disease

NCT05173701 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 88

Last updated 2022-06-10

No results posted yet for this study

Summary

Parkinson's Disease (PD) is a common neurodegenerative disease, with no disease-modifying treatment available, therapy is therefore only symptomatic. The pathophysiology of the disease is still unclear, but inflammatory mechanisms are reported to play a prominent role. An involvement of peripheral adaptive immunity, with an imbalance in T cell subpopulations and in the expression of transcriptional factors (TF) in Cluster of Differentiation (CD) 4 positive T cells has been reported. An initial aggregation of α-synuclein (α-syn) in the gut with subsequent propagation along the vagus nerve to the brain has also been hypothesised. Interestingly, in an α-syn overexpressing murine model, the absence of gut microbiota prevented both microglia activation and motor impairment, pointing to a fundamental role of the microbiota in the development of PD. It has been shown that in Peripheral Blood Mononuclear Cells (PBMC) of PD patients, probiotics modulate the in vitro production of cytokines toward an anti-inflammatory profile. The investigators developed a clinical trial protocol for the evaluation of probiotics' effects on the peripheral immune system profile in Parkinson's Disease patients. ROS, Lymphocyte subpopulations, TF levels in PBMC will be assessed at baseline and after treatment with a mixture of probiotics in PD patients to assess immunomodulatory effects of said treatment. Motor and non-motor symptoms of PD will also be monitored through the trial period.

Conditions

Interventions

DIETARY_SUPPLEMENT

Probiotics

Selected probiotics mixture, in powder form, will be administered once daily for three months in the morning.

DIETARY_SUPPLEMENT

Placebo

A placebo (2,7g maltodextrin) will be administered once daily for three months in the morning.

Sponsors & Collaborators

  • Università degli Studi del Piemonte Orientale Amedeo Avogadro

    collaborator OTHER

  • Università degli Studi dell'Insubria

    collaborator OTHER

  • Franca Marino

    lead OTHER

Principal Investigators

  • Franca Marino, Prof. · Centre for Research in Medical Pharmacology

Study Design

Allocation
RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-11-22
Primary Completion
2022-09-30
Completion
2023-01-31

Countries

  • Italy

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05173701 on ClinicalTrials.gov