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

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

Status
Active, not recruiting
Phases
Phase 4
Study type
Interventional
Source
TCTR
Registry ID
TCTR20221029004
Enrollment
60
Registered
2022-10-29
Start date
2022-10-27
Completion date
Unknown
Last updated
2026-08-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Clinical motor response in Parkinson&#039

Interventions

Experimental: Eradication therapy Patients who were positive for H. pylori infection are included into an eradication therapy protocol which includes oral amoxicillin 2,000 mg/day, oral clarithromycin
Concomitant HP eradication therapy,Change of pattern stool microbiome

Sponsors

Ramathibodi Hospital, Mahidol University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

Inclusion criteria

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

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)

Design outcomes

Primary

MeasureTime frame
Clinical motor response at 2 months from baseline Thai version MDS-UDPRS part III score

Secondary

MeasureTime frame
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

Countries

Thailand

Contacts

Public ContactWannisa Wongpipathpong

Chakri Naruebodindra Medical Institute, Faculty of Medicine Ramathibodi Hospital, Mahidol university

wwongpipathpong@gmail.com028395161

Outcome results

None listed

Source: TCTR (via WHO ICTRP) · Data processed: Aug 9, 2026