Effects of Helicobacter Pylori Infection Eradication in Patients With Parkinsons Disease

Not Applicable

• Conditions: Health Condition 1: G20- Parkinsons disease

• Registration Number: CTRI/2019/04/018524
• Lead Sponsor: Investigator Initiated Study

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 24 November 2021

Recruitment & Eligibility

• Status: ot Yet Recruiting
• Sex: Not specified
• Target Recruitment: 0

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

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.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
1. Impact on motor, and non-motor symptoms of PD patients <br/ ><br>2. Impact of Quality of life of PD patients.Timepoint: Baseline, 4th week, 8th week and 12 weeks.

Secondary Outcome Measures

Name	Time	Method
1. Prevalence of Helicobacter pylori infection in Parkinsons disease patients as compared to healthy controls. <br/ ><br>2. Severity of symptoms in PD patients with Helicobacter pylori infection.Timepoint: Baseline