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

Phase 1

Completed

• Conditions: Parkinson's Disease Aggravated
• Interventions: Drug: sodium phosphate enema, oral rifaximin and polyethylene glycol

• Registration Number: NCT04730245
• Lead Sponsor: Torre Médica Santé

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.

Study Timeline

• Study Start: 2018-06-01
• Primary Completion: 2020-03-30
• Study Completion: 2020-03-30
• Status Verified: 2021-01
• Study First Submitted: 2021-01-25
• Study First Submitted QC: 2021-01-25
• Last Update Submitted: 2021-01-25
• Study First Posted: 2021-01-29
• Last Update Posted: 2021-01-29

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 14

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Microbiota modification	sodium phosphate enema, oral rifaximin and polyethylene glycol	-

Primary Outcome Measures

Name	Time	Method
Improvement in MDS-UPDRS-IV score	3 weeks

Trial Locations

Locations (1)

Torre Medica Sante; 🇲🇽 Leon, Guanajuato, Mexico