Probiotic Use in Parkinson's Disease

NCT04140760 | Unknown

• 1 other identifier: 262286
• Study Type: interventional
• Target: 29
• Locations: 1 country
• Sites: 1

Brief Summary

1. 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. 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

Outcome Measures

Primary Outcomes (2)

• Patient Adherence to Study questionnaire

  The patient experience questionnaire (Adherence To Study) provides data about patients' experience of taking part in the study to inform a full-scale trial. These data will enable evaluation of the patient experience of taking part in the study, the experience of providing two stool samples and taking a daily capful of the placebo or probiotic liquid. This scale is developed by the researcher's. The measure is a 5-point Likert scale that includes responses: Not at all, 2 = Not really, 3 = Somewhat, 4 = Quite a lot, 5 = Very much - in the first part of the questionnaire. A sample question is: Are you happy with the consent process for taking part in the research? Total score ranges from 6-30 - low score indicates dissatisfaction with the study method and information provided. Other questions in the scale require simple 'yes' and 'no' responses. For example, 'Were you comfortable providing a stool sample for the study?'

  Thirteen weeks from study start

• Patient Exit Study Scale

  The patient exit study scale is designed to evaluate why patients did not or were unable to complete the study. The scale was devised by the researchers and comprised a 5-point Likert scale. Scores range from 7-35 with lower scores indicating dissatisfaction with particular elements of of study design, recruitment, and/or data collection. These data will inform the full-scale study

  12 and 24 weeks from study start date (only relevant for patients who withdrew).

Secondary Outcomes (5)

• Microbiome measurement: 16S rRNA gene sequencing and compositional analysis Microbiome measurement: 16S rRNA gene sequencing and compositional analysis for each patient at pre- and post-intervention

  First sample taken at week 1 of entry into study; second sample taken at week 13 after entry to study.

• The Unified Parkinson's disease rating scale (UPDRS): Fahn S, Elton R, UPDRS 1987, pp 153-163, 293-304

  Measure to be completed at week 1 of entry into study; second evaluation completed at week 13 after entry to study.

• The Parkinson's Disease Questionnaire (PDQ-39) Quality of Life Scale

  Measure to be completed at week 1 of entry into study; second evaluation completed at week 13 after entry to study.

• The Parkinson's Disease Sleep Scale

  Measure to be completed at week 1 of entry into study; second evaluation completed at week 13 after entry to study.

• Gastrointestinal Symptom Rating Scale (GSRS)

  Measure to be completed at week 1 of entry into study; second evaluation completed at week 13 after entry to study.

Study Arms (2)

Probiotic

ACTIVE COMPARATOR

Thirty five Parkinson's Disease patients group will be randomly assigned to this study arm. Participants will take the liquid probiotic (Symprove) daily following manufacturers guidelines for a period of 12 weeks.

Other: Symprove

Placebo

PLACEBO COMPARATOR

Thirty five Parkinson's Disease patients group will be randomly assigned to this study arm. Participants will take the liquid placebo daily for a period of 12 weeks following the same guidelines as for the probiotic.

Other: Symprove placebo product

Interventions

Symprove OTHER

A liquid probiotic

Probiotic

Symprove placebo product OTHER

An inert placebo

Placebo

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Diagnosis of idiopathic Parkinson's disease based on UK PD Society Brain Bank criteria.
• Capacity to consent and complete questionnaires.
• Absence of gut/intestinal disorders that would prevent use of a probiotic and/or cause diarrhoea.
• Absence of coincidental neurological condition.
• Using l-dopa plus or minus a dopaminergic agonist.
• Age over 18 and under 80

You may not qualify if:

• Unable to consent.
• Use of systemic antibiotics, antifungals, antivirals or antiparasitics (intravenous, intramuscular, or oral).
• Use of commercial probiotics: includes tablets, capsules, lozenges, chewing gum or powders in which probiotic is a primary component. Ordinary dietary components such as fermented beverages/milks, yogurts, foods do not apply.
• Presence of acute viral/bacterial infection disease at the time of sampling (defer sampling until subject recovers). Acute disease is defined as the presence of a moderate or severe illness with or without fever.
• Major surgery of the GI tract, with the exception of cholecystectomy and appendectomy, in the past five years. Any major bowel resection at any time.
• History of active uncontrolled gastrointestinal disorders or diseases including: inflammatory bowel disease (IBD) including ulcerative colitis (mild-moderate-severe), Crohn's disease (mild-moderate-severe), or indeterminate colitis.
• Presence of persistent, infectious gastroenteritis, colitis or gastritis, persistent or chronic diarrhea of unknown etiology, Clostridium difficile infection (recurrent) or Helicobacter pylori infection (untreated).
• Presence of incidental neurological illness.
• Experience of any type of cancer or adenoma less than 5 years previously.
• Age over 80

Sponsors & Collaborators

• Sheffield Hallam University: lead
• University of Sheffield: collaborator
• Sheffield Teaching Hospitals NHS Foundation Trust: collaborator

Study Sites (1)

Sheffield Hallamshire Hospital

Sheffield, South Yorkshire, S102JF, United Kingdom

Location

MeSH Terms

Conditions

Parkinson Disease

Condition Hierarchy (Ancestors)

Parkinsonian Disorders; Basal Ganglia Diseases; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Movement Disorders; Synucleinopathies; Neurodegenerative Diseases

Study Officials

• Lynne A Barker, BSc (hons) PhD

  Sheffield Hallam University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Masking Details: Study is double blind design
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 20, 2019
• First Posted: October 28, 2019
• Study Start: August 14, 2019
• Primary Completion: March 31, 2020
• Study Completion: December 22, 2020
• Last Updated: October 22, 2020

Record last verified: 2020-10

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)