Microbiota Modification for the Treatment of Motor Complication of Parkinson´s Disease (NCT04730245) | Clinical Trial Compass
CompletedPhase 1
Microbiota Modification for the Treatment of Motor Complication of Parkinson´s Disease
Mexico14 participantsStarted 2018-06-01
Plain-language summary
In recent years, abnormalities in gut microbiota have been identified in patients with Parkinson´s disease having a possible role in motor manifestations. Among 80 patients with PD, we selected 14 with LID and motor fluctuations with limited response to pharmacological therapy to receive treatment with sodium phosphate enema, oral rifaximin and polyethylene glycol to improve motor complications.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
\- patients aged 18-years old or older with moderate to severe dyskinesia and/or motor fluctuations with incomplete or poor response to adjustments in time and dose of levodopa and other anti-parkinsonian agents such as entacapone, rasagiline, dopamine receptor agonists and amantadine in 1-2 months prior to enrollment; defined by a Movement Disorders Society Unified Parkinson´s Disease Rating Scale (MDS-UPDRS) part IV score equal or higher than 8 following pharmacological adjustments.
Exclusion Criteria:
* patients with chronic renal failure, decompensated heart failure, colonic abnormalities precluding the use of evacuating enema, known allergies to prescribed medications to reduce microbiota load and patients who declined to participate in the study.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.