Helicobacter Pylori Eradication Therapy Influencing Clinical Outcomes in Parkinson disease: A Randomized Controlled Trial

Phase 4

Recruiting

• Conditions: Clinical motor response in Parkinson' s disease patients on levodopa therapyHelicobacter pylori infectionStool microbiome in Parkinson' s disease; Parkinson disease; Helicobacter pylori; Gut microbiome

• Registration Number: TCTR20221029004
• Lead Sponsor: Ramathibodi Hospital, Mahidol University

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2022-10-29
• Last Update Posted: 19 August 2024
• Study Completion: 2025-09-30

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: 60

Inclusion Criteria

Diagnosis of Idiopathic Parkinson disease (PD) by a neurologist
Written informed and consent given either by the patient or next of kin
Stable Parkinson disease with demonstrable medication efficacy (at least 90 days for L-DOPA therapy, 30 days for Dopamine agonist)

Exclusion Criteria

Patients with other concomitant active neurological diseases
Patients with dysphagia
History of previous brain surgery for Parkinson's disease
History of recent antibiotics use, proton pump inhibitors (PPIs), histamine (H2) antagonist use for at least one month prior to stool antigen test
History of previous eradication therapy for Helicobacter pylori infection
History of a previous gastric or duodenal cancer
History of a previous gastric or major abdominal/pelvic surgery
Allergy or sensitivity of proton pump inhibitor, amoxicillin, metronidazole or clarithromycin
History of recent oral medication such as warfarin, and amiodarone (drug interaction with treatment protocol)

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Clinical motor response at 2 months from baseline Thai version MDS-UDPRS part III score

Secondary Outcome Measures

Name	Time	Method
Clinical motor response at 9 months from baseline Thai version MDS-UDPRS part III score,GI symptoms at 9 months from baseline GIDS-PD,Activities of daily living scale at 9 months from baseline SE-ADL,Quality of life at 9 months from baseline PHQ-8,Non-motor symptoms at 9 months from baseline MDS-UPDRS-I, Clinical Global impression scale at 9 months from baseline CGI,Wearing-off questionnaire-9 at 9 months from baseline Thai version WOQ-9,Prevalence of a positive stool HP antigen test in Parkinson disease at first visit Prevalence,Pattern of stool microbiome in Parkinson disease before and after HP eradication therapy before and after intervention 16S rDNA gene sequencing