None listed
Conditions
Brief summary
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.
Interventions
Intervention group will receive 10 grams of OM002 once daily (soluble powder dissolved in any liquid) for 13 weeks in addition to the standard of care. Following this period both groups will receive an open-label 10 grams of OM002 for an additional 13 weeks.
Adherence will be monitoring via daily notifications and medication diary using MyCap (an application associated with the REDCap data management system) as well as study product return (at 6-weekly clinic visits)
Sponsors
University of Newcastle
Study design
Allocation
Randomised controlled trial
Intervention model
Crossover
Primary purpose
Treatment
Masking
Blinded (masking used) (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Males and females 2. Adults aged greater than or equal to 18 years of age 3. A clinical diagnosis of idiopathic PD according to the UK Parkinson's disease Society Brain Bank Diagnostic Criteria 4. Being managed by a neurologist 5. Willing to maintain current diet (and any pre- or pro-biotic regime)
Exclusion criteria
1. Secondary Parkinsonism 2. Tube feeding 3. Medical or surgical disorders preventing completion of questionnaires and significant cognitive impairment demonstrated by an incapacity to provide consent (including diagnosis of advanced cognitive impairment) 4. Pregnancy 5. Smokers 6. Oral antibiotics in the last 3 months
Outcome results
None listed