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Met-Pro Study: The Role of METhanogens in the PROgression Of Parkinson's Disease and Related Neurological Conditions

Status: Recruiting
Location: See location...
Intervention Type: Other
Study Type: Interventional
Study Phase: Not Applicable
SUMMARY

Gut problems, such as constipation, can have an important impact on quality of life of people who have them, and have been associated with higher risk of developing neurological diseases such as Parkinson's or Alzheimer's disease. Recent studies suggest that gut problems may also have implications for the progression of these diseases, as constipation is a risk factor for faster Parkinson's and Alzheimer's progression. However, how constipation and brain diseases are linked is unknown. Previous research has suggested that gut changes may lead to inflammation, which could play a role in accelerating the progression of both movement and memory problems in Parkinson's and memory and thinking problems in people with cognitive impairment. Methane is a gas that is naturally produced by microorganisms in the gut. Levels of methane can be measured using a simple breath test. Higher methane levels in the breath are thought to be more common in people with Parkinson's disease (PwP) when compared to people without Parkinson's (healthy controls) and have been associated with gut symptoms, particularly constipation, as well as worse movement problems in PwP, although they are less understood in conditions that affect memory and thinking (like dementia or mild cognitive impairment). The investigators want to better understand the changes in the gut of PwP and people with cognitive impairment (e.g. mild cognitive impairment or dementia). They will compare breath methane levels in PwP, people with cognitive impairment, people with REM Sleep Behaviour Disorder (a sleep condition linked to a higher risk of developing Parkinson's) and healthy participants. Participants will be followed-up over time to assess how methane levels are linked to changes in the blood and the stools, gut function, and clinical symptoms. This study has 2 components: Component 1: observational study, where the study investigators will follow 200 participants over 2 visits, 18 months apart. The study will recruit 4 groups of people: 50 people with Parkinson's disease, 50 people at high risk of developing Parkinson's disease (people with REM Sleep behaviour disorder), 50 people with other conditions affecting cognition (e.g. dementia, mild cognitive impairment), and 50 healthy controls. Component 2: study with 15 people with Parkinson's, who produce high methane levels, to test whether a probiotic (Lactobacillus reuteri) affects how much methane is produced.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 55
Healthy Volunteers: t
View:

⁃ People with PD:

• 55 years of age or above;

• MDS criteria for Idiopathic PD;

• H\&Y\<3.

⁃ People at high risk of developing PD (people with REM Sleep behaviour disorders):

• 55 years of age or above;

• RBD diagnosis confirmed by polysomnography.

⁃ Other conditions affecting cognition (e.g. dementia, mild cognitive impairment):

• 55 years of age or above;

• Diagnosis of non-PD dementia or MCI, or, MoCA score ≤25

⁃ Healthy Controls:

• 55 years of age or above

• MoCA total score ≥26.

Locations
Other Locations
United Kingdom
John Van Geest Centre for Brain Repair - Forvie Site, Robinson Way
RECRUITING
Cambridge
Contact Information
Primary
Marta Camacho, Dr.
msc72@cam.ac.uk
+4401223334121
Backup
Caroline Williams-Gray, Dr.
chm27@cam.ac.uk
Time Frame
Start Date: 2025-11-01
Estimated Completion Date: 2028-03
Participants
Target number of participants: 215
Treatments
Experimental: People with Parkinson's - High Methane Producers (Probiotic Intervention)
15 with high methane production identified at the baseline visit in the observational study will be invited to take 1 daily capsule of the probiotic for 18 months.
Sponsors
Collaborators: The Functional Gut Clinic, Parkinson's UK
Leads: University of Cambridge

This content was sourced from clinicaltrials.gov