Status:
COMPLETED
Microbiota Modification for the Treatment of Motor Complication of Parkinson´s Disease
Lead Sponsor:
Torre Médica Santé
Conditions:
Parkinson's Disease Aggravated
Eligibility:
All Genders
18+ years
Phase:
PHASE1
Brief 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 wit...
Detailed Description
We studied consecutive patients diagnosed with PD according to the Queen Square Brain Bank Criteria \[Hughes et al 1992\] in a tertiary care center for movement disorders, from June 2018 to March 2020...
Eligibility Criteria
Inclusion
- \- 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
- 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.
Key Trial Info
Start Date :
June 1 2018
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 30 2020
Estimated Enrollment :
14 Patients enrolled
Trial Details
Trial ID
NCT04730245
Start Date
June 1 2018
End Date
March 30 2020
Last Update
January 29 2021
Active Locations (1)
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1
Torre Medica Sante
León, Guanajuato, Mexico, 37160