Parkinson DiseaseNCT04140760
Probiotic Use in Parkinson's Disease
A study testing Symprove in people with Parkinson Disease, run by Sheffield Hallam University at 1 site in United Kingdom.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Parkinson Disease
- What is being tested?
- Symprove
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 29 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 14 Aug 2019to 22 Dec 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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.
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- 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
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
Sheffield Hallamshire Hospital
Sheffield, South Yorkshire, S102JF
About this study
Official title: Can a 12-week Probiotic Intervention Improve Wellbeing in Parkinson's Disease? A Randomised Double-blind Placebo-controlled Feasibility Study
- 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.
- To collect pilot data to determine sample size and power, reliability and sensitivity of selected measures, to maximise the findings and minimise patient burden.
Read the detailed description
The proposed research is a pilot study with 70 participants, 35 in the probiotic and 35 in the placebo arm of the study. The study will investigate the process of conducting randomised, double-blind, placebo-controlled research about probiotic use in Parkinson's Disease patients. The primary aim of the study is to test elements of the study design for a full-scale clinical study: recruitment, randomisation, probiotic use, stool sample collection and DNA sequencing and behavioural/cognitive measures. The secondary aim is to collect pilot data to determine the sample size, Power and appropriateness of measures needed for a full-scale study that maximises findings and minimises patient burden.
Parkinson's Disease (PD) is a neurodegenerative condition that affects motor functions and a range of non-motor abilities. There is no cure and a definitive cause is not yet known. It has a prevalence of 0.3% in the general population and 1-3% in the population over the age of 65. Globally, it is the second most common neurodegenerative disorder and due to the lack of early diagnosis and effective therapy, represents a large burden for society and healthcare provision. The underlying pathology of PD is associated with accumulation of abnormal clumps of alpha-synuclein protein termed Lewy bodies and Lewy neurites in the central nervous system (CNS) that impede the normal function of brain cells. Evidence from animal studies indicates that the production of alpha-synuclein begins in the gut, and gastro-intestinal problems are a common feature of PD.
The gut contains millions of micro-organisms termed the microbiome. Over the past decade research findings have identified a complex bidirectional interaction between the gastrointestinal (GI) tract and the central nervous system (CNS), the Gut-Brain axis. It is now known that the Gut-Brain axis is adversely affected by PD. Recently, probiotics have been proposed as a potential intervention for systemic and neurological conditions by improving microbiome composition.
Data obtained from this pilot study will be used to identify challenges in conducting research using probiotics in patients with Parkinson's Disease and provide a rationale for conducting a full-scale study including information that may reduce or eliminate problems that limit the successful delivery of a full-scale trial. The investigators will make no claims here about any purported clinical effects of the chosen probiotic.
- Conditions
- Parkinson Disease
- Being tested
- Symprove, Symprove placebo product
- Medical subject headings
- Parkinson Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SymproveOther
A liquid probiotic
Symprove placebo productOther
An inert placebo
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Other: Symprove placebo product |
What is being measured
The primary outcome is the main question the study is designed to answer.
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?'
Measured: 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
Measured: 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
A total of 140 samples for16S rRNAv4 Gene Sequencing and analysis n = 35 in each group, two groups (baseline and after probiotics/placebo treatment). Each patient will have two samples collected before and after probiotics/placebo treatment. Stool samples will be shipped to Diversigen (USA) for DNA extraction and sequencing
Measured: 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
The UPDRS workbook measures: I. Mentation, Behaviour, Mood - Four Subscales: Range 0-4 Total range = 0-16. II. Activities of daily living - Thirteen Subscales: Range 0-4 Total: 0-52. III. Motor Examination - Fourteen Subscales: Range 0-4 Total range 0-56. Zero = absence of symptoms, 4 = most severe presence of symptoms for all scales. Hoehn and Yahr Staging scale 0-5 (0 = no symptoms, 5 = wheelchair bound or bedridden.
Measured: 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
The user manual specifies that the questionnaire is particularly appropriate for use in clinical trials to assess treatments and interventions intended to benefit people with Parkinson's disease. Scale is 5-point Likert scale from 'Never' through to 'Always' with scores ranging from 0-4. Total score range = 0 - 156 (Lower score = better quality of life, higher score = poorer quality of life.
Measured: 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
The PDSS is a visual analogue scale addressing 15 commonly reported symptoms associated with sleep disturbance. Response options range from 0 = 'awful' to 10 = 'excellent' or 0 = 'always' to 10 = 'never.' Total score range from 0-150. Low scores indicate poor sleep or sleep related problems and high scores indicate good sleep quality.
Measured: 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)
This measure includes questions relating to 15 common gastrointestinal symptoms and requires patients to rate the severity of their symptoms over the past week or 2 weeks. It was developed from reviews of gastrointestinal symptoms and clinical experience, to evaluate common symptoms of gastrointestinal disorders. Responses range from 1 = 'No discomfort at all' to 7 = 'Very severe discomfort.' Total score range is 15-105, where 15 indicates minimal discomfort and higher rating scores indicate significant or severe discomfort.
Measured: Measure to be completed at week 1 of entry into study; second evaluation completed at week 13 after entry to study.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Oct 2019
- Study start14 Aug 2019
- Primary completion31 Mar 2020
- Study completion22 Dec 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Parkinson DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 29 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sheffield Hallam University
- Sponsor type
- University, hospital or other
- Collaborators
- University of Sheffield, Sheffield Teaching Hospitals NHS Foundation Trust
- Responsible party
- Sponsor
- Investigators
- Lynne A Barker, BSc (hons) PhD, Principal investigator, Sheffield Hallam University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04140760
- Sponsor's protocol ID
- 262286
- Status last verified
- Oct 2020
- First submitted
- 20 Sep 2019
- Last updated
- 22 Oct 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Oct 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Can a 12-week Probiotic Intervention Improve Wellbeing in Parkinson's Disease? A Randomised Double-blind Placebo-controlled Feasibility Study
- ClinicalTrials.gov ID
- NCT04140760
- Acronym / sponsor ID
- 262286
- Conditions
- Parkinson Disease
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 29 participants (actual)
- Lead sponsor
- Sheffield Hallam UniversityUniversity, hospital or other
- Collaborators
- University of Sheffield, Sheffield Teaching Hospitals NHS Foundation Trust
- Study start
- 14 Aug 2019 (actual)
- Primary completion
- 31 Mar 2020 (actual)
- Study completion
- 22 Dec 2020 (estimated)
- First posted
- 28 Oct 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
- 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.
- To collect pilot data to determine sample size and power, reliability and sensitivity of selected measures, to maximise the findings and minimise patient burden.
Detailed description
The proposed research is a pilot study with 70 participants, 35 in the probiotic and 35 in the placebo arm of the study. The study will investigate the process of conducting randomised, double-blind, placebo-controlled research about probiotic use in Parkinson's Disease patients. The primary aim of the study is to test elements of the study design for a full-scale clinical study: recruitment, randomisation, probiotic use, stool sample collection and DNA sequencing and behavioural/cognitive measures. The secondary aim is to collect pilot data to determine the sample size, Power and appropriateness of measures needed for a full-scale study that maximises findings and minimises patient burden.
Parkinson's Disease (PD) is a neurodegenerative condition that affects motor functions and a range of non-motor abilities. There is no cure and a definitive cause is not yet known. It has a prevalence of 0.3% in the general population and 1-3% in the population over the age of 65. Globally, it is the second most common neurodegenerative disorder and due to the lack of early diagnosis and effective therapy, represents a large burden for society and healthcare provision. The underlying pathology of PD is associated with accumulation of abnormal clumps of alpha-synuclein protein termed Lewy bodies and Lewy neurites in the central nervous system (CNS) that impede the normal function of brain cells. Evidence from animal studies indicates that the production of alpha-synuclein begins in the gut, and gastro-intestinal problems are a common feature of PD.
The gut contains millions of micro-organisms termed the microbiome. Over the past decade research findings have identified a complex bidirectional interaction between the gastrointestinal (GI) tract and the central nervous system (CNS), the Gut-Brain axis. It is now known that the Gut-Brain axis is adversely affected by PD. Recently, probiotics have been proposed as a potential intervention for systemic and neurological conditions by improving microbiome composition.
Data obtained from this pilot study will be used to identify challenges in conducting research using probiotics in patients with Parkinson's Disease and provide a rationale for conducting a full-scale study including information that may reduce or eliminate problems that limit the successful delivery of a full-scale trial. The investigators will make no claims here about any purported clinical effects of the chosen probiotic.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Probiotic | Active comparator | Other: SymproveThirty 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. |
| Placebo | Placebo comparator | Other: Symprove placebo productThirty 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. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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.
Key exclusion criteria (10 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| SymproveA liquid probiotic | Other | Probiotic |
| Symprove placebo productAn inert placebo | Other | Placebo |
Primary outcome
Patient Adherence to Study questionnaire
Time frame: Thirteen weeks from study start
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?'
Patient Exit Study Scale
Time frame: 12 and 24 weeks from study start date (only relevant for patients who withdrew).
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
5 secondary outcomes
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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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)
Time frame: Measure to be completed at week 1 of entry into study; second evaluation completed at week 13 after entry to study.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Oct 2020.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Lynne A Barker, BSc (hons) PhD principal investigator
Sheffield Hallam University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Symprove in people with Parkinson Disease, run by Sheffield Hallam University at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 22 Oct 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Patient Adherence to Study questionnaire (time frame: Thirteen weeks from study start). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Oct 2020.