Back to resultsMicrobiota Modification for the Treatment of Motor Complication of Parkinson´s Disease
Primary Purpose
Parkinson's Disease Aggravated
Status
Completed
Phase
Phase 1
Locations
Mexico
Study Type
Interventional
Intervention
sodium phosphate enema, oral rifaximin and polyethylene glycol
Sponsored by
About this trial
This is an interventional treatment trial for Parkinson's Disease Aggravated focused on measuring Parkinson´s disease, Constipation, Dyskinesia, Microbiota
Eligibility Criteria
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.
Sites / Locations
- Torre Medica Sante
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Microbiota modification
Arm Description
Outcomes
Primary Outcome Measures
Improvement in MDS-UPDRS-IV score
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04730245
Brief Title
Microbiota Modification for the Treatment of Motor Complication of Parkinson´s Disease
Official Title
Targeting Gut Microbiota for Motor Complications in Parkinson´s Disease
Study Type
Interventional
2. Study Status
Record Verification Date
January 2021
Overall Recruitment Status
Completed
Study Start Date
June 1, 2018 (Actual)
Primary Completion Date
March 30, 2020 (Actual)
Study Completion Date
March 30, 2020 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Torre Médica Santé
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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 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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Parkinson's Disease Aggravated
Keywords
Parkinson´s disease, Constipation, Dyskinesia, Microbiota
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
14 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Microbiota modification
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
sodium phosphate enema, oral rifaximin and polyethylene glycol
Intervention Description
Patients were hospitalized for 4-5 hours to receive two saline colon enemas with sodium phosphate Fleet®, 2 to 3 hours apart, appropriate hydration was provided during the procedure. If signs of fecal impaction were observed, the stools were removed manually prior to the first enema. Patients were discharged with oral treatment consistent with rifaximin 200 mg three times a day for 7 days and polyethylene glycol-3350, 17 gr per day in water for 10 days, but it was continued if necessary. Importantly, no modifications in time and dose of dopaminergic therapy or anti-dyskinetic medication (i.e. amantadine) were done at baseline or during the study
Primary Outcome Measure Information:
Title
Improvement in MDS-UPDRS-IV score
Time Frame
3 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
José Fidel Baizabal-Carvallo, M.D.
Organizational Affiliation
Torre Médica Sante
Official's Role
Principal Investigator
Facility Information:
Facility Name
Torre Medica Sante
City
Leon
State/Province
Guanajuato
ZIP/Postal Code
37160
Country
Mexico
12. IPD Sharing Statement
Plan to Share IPD
Undecided
IPD Sharing Plan Description
May be shared by specific request
Learn more about this trial
Microbiota Modification for the Treatment of Motor Complication of Parkinson´s Disease
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