Gut methane and Parkinson's: measuring if a probiotic helps people with Parkinson's, REM sleep behavior disorder, or cognitive concerns

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This interventional study examines whether probiotic supplementation with L. reuteri impacts gut methane production and clinical features in people with Parkinson's disease, individuals with REM sleep behavior disorder, and those with cognitive concerns. Participants are grouped by disease status and may provide breath samples to assess intestinal methane levels, along with symptom and cognitive assessments. The study builds on evidence linking gut microbiota, constipation, and inflammation to disease progression and aims to see if modifying the gut environment can influence motor and cognitive outcomes. The design emphasizes non-invasive assessment and translational relevance to patient care through a gut-brain axis approach. Lead institutions include the University of Cambridge with collaborators Parkinson's UK and The Functional Gut Clinic, located in Cambridge, UK.

Why it matters

Who can join: the full rules

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 ≤25

Healthy Controls:

* 55 years of age or above
* MoCA total score ≥26.

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).

Where it's running

• John Van Geest Centre for Brain Repair - Forvie Site, Robinson Way
  Cambridge, Cb2, United Kingdom Recruiting

Study contacts

• Principal investigator: Marta Camacho, Dr. — Parkinson's UK Senior Research Fellow John van Geest Centre for Brain Repair, University of Cambridge
• Study coordinator: Marta Camacho, Dr.
• Email: msc72@cam.ac.uk
• Phone: +4401223334121

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.