A clinical trial of a prebiotic powder for symptoms of Parkinson’s disease

OM002 is a synthetic oligosaccharide that is identical to the human milk oligosaccharide (HMO) 2’ fucosyllactose (2'FL) and has the potential to address the underlying pathophysiology of Parkinson’s Disease (PD) constipation and address unmet clinical needs in these patients. This study is being conducted to assess the safety and efficacy of OM002 relating to reduced severity of constipation and disease progression in patients with PD. This double-blind, randomized, placebo-controlled study trial will consist of two groups (n=80/each) who will receive either OM002 or placebo for 13 weeks in addition to the standard of care. Following this period both groups will receive an open-label for an additional 13 weeks. Biological samples and surveys will be sampled at 5 time points (baseline, mid-treatment, completion of first arm (13 weeks), mid-open-label treatment, and at the end of the open-label treatment period (13 weeks)). Trial data will be used in combination with available open-label data to guide the late-stage development of OM002 in participants with PD. We hypothesise that ingestion of 10 grams of OM002 daily will improve cognitive function and reduce GI symptom severity in patients diagnosed with PD.