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

Torre Médica Santé

Status and phase

Completed

Phase 1

Conditions

Parkinson's Disease Aggravated

Treatments

Drug: sodium phosphate enema, oral rifaximin and polyethylene glycol

Study type

Interventional

Funder types

NETWORK

Identifiers

NCT04730245

202004-001

Details and patient eligibility

About

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.

Full 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.

Enrollment

14 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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.