Health Condition 1: G20- Parkinsons disease
Conditions
Interventions
Intervention1: Helicobacter pylori eradication Therapy: Omeprazole, Amoxicillin, Clarithromycin
Control Intervention1: Placebo: Identical placebo will be provided
Sponsors
Investigator Initiated Study
Eligibility
Inclusion criteria
Inclusion criteria: 1. PD patients diagnosed based on UKPDS brain bank criteria and Hoehn and Yahr score of 2-4. 2. Patients on stable drug therapy for at least 30 days, with wearing off phenomenon existing between L-Dopa dosing (mean daily off time >=3 hours) 3. Normal cognition (Montreal cognitive assessment score >25) 4. Patient who are willing to give consent for participation.
Exclusion criteria
Exclusion criteria: 1. Ongoing symptoms of abdominal pain, unexplained nausea and vomiting, or GI bleeds. 2. History of HP associated conditions - gastric carcinoma, peptic ulcer disease, duodenal ulcer, or other gastric or duodenal conditions. 3. Patients with a history of past gastric surgery. 4. History of prior neurosurgery for PD. 5. History of stomach cancer in the family. 6. Prior HP eradication treatment or diagnosis. 7. Recent use of PPIs, amoxicillin, clarithromycin, metronidazole, colloidal bismuth sub citrate (CBS) with past 4 weeks. 8. Allergy or sensitivity to HP eradication treatment regimen component drugs. 9. Use of drugs that affect GI motility such as domperidone, metoclopramide 10. Inability to participate/tolerate the morning testing during the study in an "off" state. 11. Pregnancy. 12. Parkinson- plus syndrome e.g. MSA, PSP, corticobasal degeneration (CBD), or Lewy body dementia. 13. Secondary causes of parkinsonism e.g. vascular parkinsonism, major head injury, past h/o encephalitis, neuroleptic treatment at onset of symptoms, h/o psychiatric disease, reversible cause of parkinsonism. 14. Patients refuse to participate in the study and not willing to give consent.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1. Impact on motor, and non-motor symptoms of PD patients 2. Impact of Quality of life of PD patients.Timepoint: Baseline, 4th week, 8th week and 12 weeks. | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Prevalence of Helicobacter pylori infection in Parkinsons disease patients as compared to healthy controls. 2. Severity of symptoms in PD patients with Helicobacter pylori infection.Timepoint: Baseline | — |
Countries
India
Contacts
Public ContactDr Gopal Vishwas
PGIMER, Chandigarh
Outcome results
None listed