Constipation and Changes in the Gut Flora in Parkinson's Disease (GUT-PD)

April 10, 2023 updated by: University of Aberdeen

Constipation and Changes in the Gut Flora in Parkinson's Disease: a Pilot Study

The aim of this study is to investigate the link between gut health and Parkinson's disease

Study Overview

Status

Recruiting

Conditions

Detailed Description

Parkinson's disease (PD) is a common, age-related neurological condition, affecting approximately 145,000 people in the United Kingdom. Diagnostic symptoms include stiffness, tremor, unsteadiness and slow movements. Interestingly, while PD is usually considered to be a neurological condition, pathological changes occur in the gut years before diagnosis, often causing constipation. As such, the gut has attracted attention as a possible therapeutic target.

Previous studies have shown different profiles of gut bacteria and the short chain fatty acids (SCFAs) they produce in people with PD. There is evidence these changes might be significant to the disease course, as faecal transplants from people with PD worsened symptoms in a mouse model of PD. The mechanism for this is unclear, but changes in SCFAs and gut wall inflammation, have both been suggested. Studies so far have compared gut bacteria in people with and without PD, however, as the healthy controls often don't have constipation, it is unclear if the differences seen are due to PD itself or the associated constipation.

This pilot study aims to determine differences in the frequency of gut micro-organisms (bacteria, fungi and archaea) and gut function, other than those caused by constipation. 40 participants with a new diagnosis of PD will be recruited from Movement Disorder clinics within National Health Service (NHS) Grampian. 40 healthy (non-PD) controls will be recruited from the PD participants households (whenever feasible). All 80 participants will be clinically assessed and asked to provide two stool samples. The samples will be analysed for the frequency of gut micro-organisms, changes in gut function (short chain fatty acid concentrations) and gut inflammation (calprotectin concentrations).

The aim of this pilot study is to determine the key differences in gut micro-organisms in PD compared to controls, which may have a role in disease progression. It is likely that the results of this proof of concept study would need to be confirmed in a larger study before the investigators are able to plan an intervention trial, such as testing a prebiotic product, with the aim of normalising gut micro-organisms, and potentially modifying the disease course.

Study Type

Observational

Enrollment (Anticipated)

80

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • United Kingdom
    • Aberdeen City
      • Aberdeen, Aberdeen City, United Kingdom, AB25 2ZD
        • Recruiting
        • Human Nutrition Unit, Rowett Institute, University of Aberdeen
        • Contact:
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 110 years (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Sampling Method

Non-Probability Sample

Study Population

Parkinson disease group: potential participants will be invited into the study if they have recently been diagnosed with Parkinson's disease and have not yet started medication for the condition

Control group: spouses or other household contacts will be invited to the study

Description

Inclusion Criteria:

Participants with Parkinson's disease 2. Community-dwelling patients with newly diagnosed PD who have not yet started medication for Parkinson's disease.

Control Participants

1. Healthy (non-Parkinsonian) members of the participants household will be invited to act as controls.

Exclusion Criteria:

  1. Use of oral or intravenous antibiotics in the last 8 weeks.
  2. Active gastrointestinal disease, not including constipation or irritable bowel syndrome without other symptoms.
  3. Current use of medications which cause/worsen constipation e.g., opioids, tramadol, gabapentin, pregabalin.
  4. Potential controls will be excluded if they report prodromal symptoms of PD, such as anosmia or rapid eye movement (REM) sleep disorder or display parkinsonian signs on examination.
  5. Inability to give informed consent at any stage of the study e.g., because of dementia.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Parkinson disease
Participants with newly diagnosed Parkinson's disease
Control Subjects
Control subjects - will be selected from household/spousal contacts of the participants with Parkinson's disease

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Micro-organism prevalence in stool sample
Time Frame: Baseline
Stool samples will be posted to the Rowett Institute, and processed and analysed in the laboratory at The Rowett Institute, University of Aberdeen. The samples will be analysed for water content and microbial RNA/DNA will be extracted for genome analysis. When the analysis is complete, the faecal samples will be destroyed.
Baseline
Micro-organism prevalence in stool sample
Time Frame: Within two months of baseline
Stool samples will be posted to the Rowett Institute, and processed and analysed in the laboratory at The Rowett Institute, University of Aberdeen. The samples will be analysed for water content and microbial RNA/DNA will be extracted for genome analysis. When the analysis is complete, the faecal samples will be destroyed.
Within two months of baseline

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Analysis of stool samples for concentration of short chain fatty acids
Time Frame: Baseline
Stool samples will be posted to the Rowett Institute via Royal Mail. Samples will be processed and analysed in the laboratory at The Rowett Institute, University of Aberdeen. The samples will be analysed for short chain fatty acid concentration (µmol/g).
Baseline
Analysis of stool samples for concentration of calprotectin
Time Frame: Baseline
Stool samples will be posted to the Rowett Institute via Royal Mail. Samples will be processed and analysed in the laboratory at The Rowett Institute, University of Aberdeen. The samples will be analysed for short calprotectin concentration (µg/g).
Baseline
Analysis of stool samples for markers of gut function (short chain fatty acids and calprotectin)
Time Frame: Within two months of the baseline sample
Stool samples will be posted to the Rowett Institute via Royal Mail. Samples will be processed and analysed in the laboratory at The Rowett Institute, University of Aberdeen. The samples will be analysed for short chain fatty acid (SCFA) profile and calprotectin concentration. When the analysis is complete, the faecal samples will be destroyed.
Within two months of the baseline sample
To assess the extent of swallowing problems (dysphagia) by a questionnaire
Time Frame: Baseline
Participants will be asked to completed a standardized swallowing questionnaire (Swallowing Disturbance Questionnaire), which has been validated in people with Parkinson's disease. The score ranges from 0-43, with a higher score increasing the likelihood for a swallowing problem, which would require further investigation
Baseline
To assess the extent of swallowing problems using a standardized swallowing test
Time Frame: Baseline
Participants will be asked to drink 150 millilitres of cold water from a clear cup. The rater will sit at their side and record them on video for later analysis. The speed in ml/second and volume per average swallow will be recorded by determining if any residual volume is left, the number of seconds to complete the task and the number of swallows. The test will be terminated if there is any indication of aspiration of liquid.
Baseline
To assess the extent of swallowing problems using a standardized swallowing test
Time Frame: Four weeks after the baseline assessment
Participants will be asked to drink 150 millilitres of cold water from a clear cup. The rater will sit at their side and record them on video for later analysis. The speed in ml/second and volume per average swallow will be recorded by determining if any residual volume is left, the number of seconds to complete the task and the number of swallows. The test will be terminated if there is any indication of aspiration of liquid.
Four weeks after the baseline assessment
To assess taste sensation using a simple test
Time Frame: Baseline
Participants taste recognition will be assessed using standardized taste strips from Burghart (sweet, salty, sour and bitter)
Baseline
To assess dietary intake over a 24 hour period using a structured interview
Time Frame: Baseline
Following the initial visit, the participant will receive a phone call from a trained member of the team to perform a 24-hour dietary recall interview. This is a structured interview where participants are asked to recall all food and beverage consumption over a 24-hour period and further questions are asked to determine further details, including portion size and ingredients and cooking methods used. The whole interview usually takes 20 to 60 minutes.
Baseline
To assess the reliability of bio-impedence analysis in determining fat mass in older adults with and without PD
Time Frame: Baseline
Fat mass in kilograms will be measured using a seca mBCA 525 bio-impedence machine.
Baseline
To assess the reliability of bio-impedence analysis in determining fat mass in older adults
Time Frame: Four weeks after baseline assessment
Fat mass in kilograms will be measured using a seca mBCA 525 bio-impedence machine.
Four weeks after baseline assessment
To assess the reliability of bio-impedence analysis in determining fat mass in older adults
Time Frame: Baseline
Fat free mass in kilograms will be measured using a seca mBCA 525 bio-impedence machine.
Baseline
To assess the reliability of bio-impedence analysis in determining fat mass in older adults
Time Frame: Four weeks after the baseline assessment
Fat free mass in kilograms will be measured using a seca mBCA 525 bio-impedence machine.
Four weeks after the baseline assessment

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Aberdeen

Collaborators

NHS Grampian
Biomathematics & Statistics Scotland (BioSS)

Investigators

  • Principal Investigator: Isobel JM Sleeman, BMBCh, PhD, University of Aberdeen

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 1, 2023

Primary Completion (Anticipated)

August 30, 2023

Study Completion (Anticipated)

October 30, 2023

Study Registration Dates

First Submitted

March 1, 2023

First Submitted That Met QC Criteria

March 15, 2023

First Posted (Actual)

March 28, 2023

Study Record Updates

Last Update Posted (Actual)

April 12, 2023

Last Update Submitted That Met QC Criteria

April 10, 2023

Last Verified

April 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2-048-21

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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