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The Role of METhanogens in the PROgression Of Parkinson's Disease and Related Neurological Conditions

RecruitingNAAges 55 Years - anyAllUniversity of Cambridge
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In plain words

What the trial is, and whether it could suit you

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 le

Sign in to get the eligibility rules as simple questions to take to your doctor.

๐Ÿ“‹ Eligibility rules (as published)
Inclusion Criteria: 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 โ‰ค25 Healthy Controls: * 55 years of age or above * MoCA total score โ‰ฅ26. Exclusion Criteria: * Presence of other neurological disorder, chronic inflammatory/autoimmune disorder, active cancer, active metabolic disease, diabetes type I and II, and active or latent infection; * Use of immunosuppressive drugs within the preceding 12 months; * Use of oral/intravenous steroids within the preceding 3 months; * Regular use (more than twice per week) of non-steroidal anti-inflammatory drugs (e.g. ibuprofen, naproxen, diclofenac, meloxicam) or over 75mg aspirin; * Participation in other interventional studies, within the preceding 3 months; * Consumption of laxatives, stool softeners, stool bulking agents, motility agents, iron supplements and probiotics within the preceding 3 months; * Current smoker * Inability to understand or speak English fluently. For participants in Component 2 of the study (Experimental Medicine Study), additional exclusion criteria will be in place, namely, known allergy to any of the probiotic's ingredients: Bulking agent (isomalt), sweetener (xylitol), L. reuteri DSM 17938, strawberry flavouring and flavour enhancer (citric acid).
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What it tests

  • Probiotic Supplementation with L. reuteri
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Where

1 site
John Van Geest Centre for Brain Repair - Forvie Site, Robinson Way
Cambridge, United Kingdom
๐Ÿค Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible โ€” always decide together with your own doctor.
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