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

NCT ID: NCT04730245

Last Updated: 2021-01-29

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

14 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-06-01

Study Completion Date

2020-03-30

Brief Summary

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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

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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.

Conditions

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Parkinson's Disease Aggravated

Keywords

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Parkinson´s disease Constipation Dyskinesia Microbiota

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Microbiota modification

Group Type EXPERIMENTAL

sodium phosphate enema, oral rifaximin and polyethylene glycol

Intervention Type DRUG

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

Interventions

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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

Intervention Type DRUG

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Torre Médica Santé

NETWORK

Sponsor Role lead

Responsible Party

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José Fidel Baizabal-Carvallo

Neurologist, physician, investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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José Fidel Baizabal-Carvallo, M.D.

Role: PRINCIPAL_INVESTIGATOR

Torre Médica Sante

Locations

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Torre Medica Sante

León, Guanajuato, Mexico

Site Status

Countries

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Mexico

Other Identifiers

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202004-001

Identifier Type: -

Identifier Source: org_study_id