Clinical trial for PARKINSON DISEASE (Disorder)
Official title The Role of METhanogens in the PROgression Of Parkinson's Disease and Related Neurological Conditions
ClinicalTrials.gov ID: NCT07786116
What this study is testing
- What it's testing
- The study aims to learn whether the amount of methane gas in a breath test is linked to gut changes and the worsening of movement or memory problems. It also tests if a probiotic can lower methane in Parkinson's patients who have high levels.
- Who it's for
- Adults who have Parkinson's disease, REM sleep behavior disorder, mild cognitive impairment or dementia, or who are healthy volunteers.
- What's involved
- Participants will give breath samples, blood and stool tests, and answer questionnaires at two clinic visits. A small group of 15 Parkinson's patients with high methane will also take a probiotic for a short period.
- Time commitment
- Two clinic visits about 18 months apart (plus the probiotic period for the small group).
- Time commitment: about 18 months
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 55 and older. Healthy volunteers may be eligible.
You may be able to join if
- 55 years of age or above;
- MDS criteria for Idiopathic PD;
- 55 years of age or above;
- 55 years of age or above;
- 55 years of age or above
You likely can't join if
- Presence of other neurological disorder, chronic inflammatory/autoimmune disorder, active cancer, active metabolic disease, diabetes type I and II...
- 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.
- Participation in other treatment 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;
See the full eligibility criteria
- 55 years of age or above;
- MDS criteria for Idiopathic PD;
- 55 years of age or above;
- 55 years of age or above;
- 55 years of age or above
- MoCA total score ≥26.
- 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 treatment 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...
The study team makes the final eligibility decision.
Where it is enrolling
- Cambridge, CB2, United Kingdom
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part, but confirm specifics with the study team.
How long does this study last?
The study runs about 18 months per participant, based on its public description. The team confirms the exact schedule and number of visits before you enroll.
Who can join this trial?
This study is enrolling all sexes, 55 years and older. Healthy volunteers may be eligible. The study team makes the final eligibility decision.
Where is this trial taking place?
This study is enrolling now at Cambridge, CB2, United Kingdom. Enter your location above to see the nearest enrolling site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool that is independent of the study sponsor. Details come from ClinicalTrials.gov. The study team decides eligibility, and your own doctor gives medical advice.