Study Rationale:
Individuals with Parkinson's disease (PD) frequently suffer from constipation; those with PD also have altered bacterial composition in the gut. The RESISTA-PD trial investigates whether daily intake of a dietary supplement (resistant starch, provided as a water-soluble powder) can change gut bacteria composition and whether this supplement can improve bowel habits.
Hypothesis:
Resistant starch (administered as a daily dietary supplement) changes gut bacteria composition and ameliorates symptoms of constipation in PD.
Study Design:
Participants in this trial will receive a daily dietary supplement (resistant starch) over a period of eight weeks. They will also undergo a comprehensive assessment with questionnaires and will keep a diary across the eight weeks of testing to identify changes in bowel habits. Stool samples will be collected prior to supplement administration and four and eight weeks after administration. Samples will be analyzed to evaluate gut bacteria and substances produced by gut bacteria (short-chain fatty acids, products of bacteria breakdown).
Impact on Diagnosis/Treatment of Parkinson's Disease:
Constipation in those with PD severely affects quality of life and is not always resolved by conventional treatments. In addition, gut bacteria may play a more direct role in PD. Therefore, pre-biotic intervention with resistant starch is a promising therapeutic strategy for constipation in those with PD. In addition, this trial will provide information about the relevance of gut bacteria and their products for PD.
Next Steps for Development:
Resistant starch is available as a dietary supplement in many countries. Provided the RESISTA-PD trial proves beneficial effects on bowel habits, resistant starch could be readily used to improve constipation in those with PD.
Trial Phase: Equivalent to a Phase II study