Objective/Rationale:
Helicobacter pylori is a common bacterial infection often associated with disorders of the gastrointestinal tract. Treatment of H. pylori in patients with Parkinson’s disease has been shown to improve clinical response to standard doses of levodopa, with increased blood levels indicating better absorption. We will evaluate 1) the frequency of infection with H. pylori in PD patients who have wearing off symptoms and 2) whether treatment of these patients leads to reduced wearing off in a clinical setting.
Project Description:
For this pilot study, we will enroll PD patients taking levodopa who have developed significant (at least 3 hours/day) wearing off and screen them for H. pylori infection with routine blood testing for antibodies to the bacterium. Those with evidence of H. pylori infection will be randomized in a double-blinded fashion to either early or late treatment with a standard antibiotic regimen, receiving placebo treatment during the other time period. We will analyze change in total daily off time (as measured by patient-completed daily diaries) at various time points after treatment, along with well-established measures of motor function and quality of life. We will also verify H. pylori eradication at study completion.
Relevance to Diagnosis/Treatment of Parkinson’s Disease:
Treatment of motor fluctuations like wearing off is a difficult problem for many PD patients. If a significant proportion of PD patients have H. pylori infection, and treatment results in clinically meaningful improvement, then this would justify screening for and treatment of H. pylori infection in other similarly affected patients. This could help improve the overall effectiveness of their PD therapy.
Anticipated Outcome:
We anticipate that approximately half of PD patients with significant wearing off will be carriers of H. pylori and that treatment of the bacteria will significantly improve wearing off. Improving the wearing off of levodopa therapy would be expected to increase total on time and improve quality of life.
Final Outcome
Helicobacter pylori is a common bacterial infection often associated with disorders of the gastrointestinal tract. Treatment of H. pylori in patients with Parkinson’s disease (PD) has been shown to improve clinical response to standard doses of levodopa, with increased blood levels indicating better absorption. We evaluated the frequency of infection with H. pylori in PD patients and whether treatment of these patients leads to reduced wearing off. We tested 54 subjects with PD for H. pylori status and found that 13 (24%) were positive and an additional two (4%) were “borderline”. This incidence is much lower than that reported by others. Only two H. pylori positive (HP+) patients reported significant wearing off and neither were able to complete the treatment phase of the study. All HP+ patients were offered antibiotic treatment and informal responses were recorded. All but one patient reported no change in PD symptoms. One patient reported some improvement in wearing off but this was not sustained after six months. In summary, this preliminary study suggests that the incidence of H. pylori infection is lower in at least some populations than previously believed but the benefits of treatment could not be adequately accessed.