Constipation and Changes in the Gut Flora in Parkinson's Disease

NCT05787756 | Unknown DMC

• 1 other identifier: 2-048-21
• Study Type: observational
• Target: 80
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Parkinson Disease

Outcome Measures

Primary Outcomes (2)

• Micro-organism prevalence in stool sample

  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

  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 Outcomes (12)

• Analysis of stool samples for concentration of short chain fatty acids

  Baseline

• Analysis of stool samples for concentration of calprotectin

  Baseline

• Analysis of stool samples for markers of gut function (short chain fatty acids and calprotectin)

  Within two months of the baseline sample

• To assess the extent of swallowing problems (dysphagia) by a questionnaire

  Baseline

• To assess the extent of swallowing problems using a standardized swallowing test

  Baseline

Study Arms (2)

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

Eligibility Criteria

• Age: 18 Years - 110 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• 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

You may qualify if:

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

You may not qualify if:

• Use of oral or intravenous antibiotics in the last 8 weeks.
• Active gastrointestinal disease, not including constipation or irritable bowel syndrome without other symptoms.
• Current use of medications which cause/worsen constipation e.g., opioids, tramadol, gabapentin, pregabalin.
• 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.
• Inability to give informed consent at any stage of the study e.g., because of dementia.

Sponsors & Collaborators

• University of Aberdeen: lead
• Biomathematics & Statistics Scotland (BioSS): collaborator
• NHS Grampian: collaborator

Study Sites (1)

Human Nutrition Unit, Rowett Institute, University of Aberdeen

Aberdeen, Aberdeen City, AB25 2ZD, United Kingdom

RECRUITING

Related Publications (9)

• Gage H, Kaye J, Kimber A, Storey L, Egan M, Qiao Y, Trend P. Correlates of constipation in people with Parkinson's. Parkinsonism Relat Disord. 2011 Feb;17(2):106-11. doi: 10.1016/j.parkreldis.2010.11.003. Epub 2010 Dec 3.

  PMID: 21130017 BACKGROUND

• De Pablo-Fernandez E, Gebeyehu GG, Flain L, Slater R, Frau A, Ijaz UZ, Warner T, Probert C. The faecal metabolome and mycobiome in Parkinson's disease. Parkinsonism Relat Disord. 2022 Feb;95:65-69. doi: 10.1016/j.parkreldis.2022.01.005. Epub 2022 Jan 13.

  PMID: 35045378 BACKGROUND

• Hilton D, Stephens M, Kirk L, Edwards P, Potter R, Zajicek J, Broughton E, Hagan H, Carroll C. Accumulation of alpha-synuclein in the bowel of patients in the pre-clinical phase of Parkinson's disease. Acta Neuropathol. 2014 Feb;127(2):235-41. doi: 10.1007/s00401-013-1214-6. Epub 2013 Nov 17.

  PMID: 24240814 BACKGROUND

• Jaffrin MY, Morel H. Body fluid volumes measurements by impedance: A review of bioimpedance spectroscopy (BIS) and bioimpedance analysis (BIA) methods. Med Eng Phys. 2008 Dec;30(10):1257-69. doi: 10.1016/j.medengphy.2008.06.009. Epub 2008 Aug 3.

  PMID: 18676172 BACKGROUND

• Manor Y, Giladi N, Cohen A, Fliss DM, Cohen JT. Validation of a swallowing disturbance questionnaire for detecting dysphagia in patients with Parkinson's disease. Mov Disord. 2007 Oct 15;22(13):1917-21. doi: 10.1002/mds.21625.

  PMID: 17588237 BACKGROUND

• Mueller C, Kallert S, Renner B, Stiassny K, Temmel AF, Hummel T, Kobal G. Quantitative assessment of gustatory function in a clinical context using impregnated "taste strips". Rhinology. 2003 Mar;41(1):2-6.

  PMID: 12677732 BACKGROUND

• Sampson TR, Debelius JW, Thron T, Janssen S, Shastri GG, Ilhan ZE, Challis C, Schretter CE, Rocha S, Gradinaru V, Chesselet MF, Keshavarzian A, Shannon KM, Krajmalnik-Brown R, Wittung-Stafshede P, Knight R, Mazmanian SK. Gut Microbiota Regulate Motor Deficits and Neuroinflammation in a Model of Parkinson's Disease. Cell. 2016 Dec 1;167(6):1469-1480.e12. doi: 10.1016/j.cell.2016.11.018.

  PMID: 27912057 BACKGROUND

• Schwiertz A, Spiegel J, Dillmann U, Grundmann D, Burmann J, Fassbender K, Schafer KH, Unger MM. Fecal markers of intestinal inflammation and intestinal permeability are elevated in Parkinson's disease. Parkinsonism Relat Disord. 2018 May;50:104-107. doi: 10.1016/j.parkreldis.2018.02.022. Epub 2018 Feb 12.

  PMID: 29454662 BACKGROUND

• Unger MM, Spiegel J, Dillmann KU, Grundmann D, Philippeit H, Burmann J, Fassbender K, Schwiertz A, Schafer KH. Short chain fatty acids and gut microbiota differ between patients with Parkinson's disease and age-matched controls. Parkinsonism Relat Disord. 2016 Nov;32:66-72. doi: 10.1016/j.parkreldis.2016.08.019. Epub 2016 Aug 26.

  PMID: 27591074 BACKGROUND

Biospecimen

Retention: SAMPLES WITH DNA

two stool samples

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

• Isobel JM Sleeman, BMBCh, PhD

  University of Aberdeen

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Isobel JM Sleeman, BMBCh, PhD

CONTACT

07471234054; isobel.sleeman@abdn.ac.uk

Angus Macleod, MBChB, PhD

CONTACT

01224 437120; angus.macleod@abdn.ac.uk

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 1, 2023
• First Posted: March 28, 2023
• Study Start: January 1, 2023
• Primary Completion: August 30, 2023
• Study Completion: October 30, 2023
• Last Updated: April 12, 2023

Record last verified: 2023-04

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)