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Probiotic Use in Parkinson's Disease

NCT04140760 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 29

Last updated 2020-10-22

No results posted yet for this study

Summary

1. To evaluate the components and processes needed for a full-scale clinical study: recruitment, randomisation, attrition, probiotic use, stool sample collection, microbiome sequencing and behavioural/cognitive measures and determine the feasibility and patient acceptability of these processes to inform a full-scale study in line with NIHR pilot study guidance.
2. To collect pilot data to determine sample size and power, reliability and sensitivity of selected measures, to maximise the findings and minimise patient burden.

Conditions

  • Parkinson Disease

Interventions

OTHER

Symprove

A liquid probiotic

OTHER

Symprove placebo product

An inert placebo

Sponsors & Collaborators

  • University of Sheffield

    collaborator OTHER

  • Sheffield Teaching Hospitals NHS Foundation Trust

    collaborator OTHER

  • Sheffield Hallam University

    lead OTHER

Principal Investigators

  • Lynne A Barker, BSc (hons) PhD · Sheffield Hallam University

Study Design

Allocation
RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-08-14
Primary Completion
2020-03-31
Completion
2020-12-22

Countries

  • United Kingdom

Study Locations

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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 NCT04140760 on ClinicalTrials.gov