Microbiota Modification for the Treatment of Motor Complication of Parkinson´s Disease

Parkinson's Disease Aggravated Clinical Trial

Official title:

Targeting Gut Microbiota for Motor Complications in Parkinson´s Disease

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04730245
• Other study ID #: 202004-001
• Status: Completed
• Phase: Phase 1
• Start date: June 1, 2018
• Est. completion date: March 30, 2020

Study information

• Verified date: January 2021
• Source: Torre Médica Santé
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 14
• Est. completion date: March 30, 2020
• Est. primary completion date: March 30, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Parkinson Disease
• Parkinson's Disease Aggravated

Intervention

Drug:
• sodium phosphate enema, oral rifaximin and polyethylene glycol
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

Locations

Country	Name	City	State
Mexico	Torre Medica Sante	Leon	Guanajuato

Sponsors (1)

Lead Sponsor	Collaborator
Torre Médica Santé

Country where clinical trial is conducted

Mexico, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Improvement in MDS-UPDRS-IV score		3 weeks