Parkinson's Disease Gut Microbiome Intervention Trial Protocol

Eighty participants with Parkinson's disease were randomized into four intervention arms for a pilot study. The dataset contains the study protocol for the PRIME trial, which investigates the effects of a Mediterranean diet and physical activity on the gut microbiome and disease progression.

Use Cases

• Analyze the randomization scheme for the four intervention arms (Mediterranean diet, physical activity, combination, control) to assess trial design.
• Correlate intervention-induced changes in gut microbiome profiles, characterized via 16s rRNA and third-generation sequencing, with clinical outcomes.
• Examine the integration of microbiome data with clinical metrics for disease progression, symptoms, cognition, and quality of life.

Strengths

• Data originates from a registered, multicenter randomized controlled pilot study (NCT07097103).
• Protocol explicitly integrates gut microbiome analysis with multiple clinical intervention assessments.
• Dataset is openly shared under a CC BY 4.0 license for reuse.

Limitations

• The dataset is small (12.9 KB), containing the study protocol, not the full trial results or participant-level data.
• As a protocol, it describes planned methods; actual experimental results and microbiome data are not included.
• The sample size is limited to 80 participants, typical for a pilot study.

Provenance

Source

ClinicalTrials.gov identifier NCT07097103, published on figshare.

Collection Method

Randomized controlled trial protocol for a multicenter pilot study.

Time Range

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Freshness

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Geography

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