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Open Label Single Arm Prebiotic Pilot Trial SR001
Sponsor: Sorridi Therapeutics
Summary
The goal of this pilot clinical study is to evaluate the effect of a prebiotic fiber blend in individuals diagnosed with Parkinson's Disease. The main objectives of this pilot study are: 1. To assess the safety and tolerability of consuming 1 fiber bar/day 2. To determine if a prebiotic fiber blend impacts biological metrics and non-motor symptoms of Parkinsons Disease 3. To evaluate the effect of the fiber bar on intestinal inflammation Participants will have blood and fecal samples collected at baseline and after 4 weeks of intervention. Participants will also complete questionnaires to monitor GI symptom severity, quality of life metrics, and Parkinson's-specific surveys. Researchers will compare biomarkers and reported assessment answers at baseline and after 4 weeks with intervention.
Official title: A Single Arm, Open Label Study to Assess the Tolerability of a Prebiotic in Adults With Parkinson's Disease and Healthy Adults
Key Details
Gender
All
Age Range
60 Years - 75 Years
Study Type
INTERVENTIONAL
Enrollment
20
Start Date
2024-07-01
Completion Date
2025-11
Last Updated
2025-08-17
Healthy Volunteers
Yes
Conditions
Interventions
Prebiotic fiber blend
Proprietary blend of 5 prebiotic fibers and normal bar excipients Product name: NeuroFiber Dosage form: Single bar/day Storage conditions: The Study Product delivered by Sorridi to patient/subject at the beginning of study. Any remainder will be collected by Sorridi at end of study. Product is to be stored at room temperature in the patient's/subject's homes. The bar will be produced and packaged at a licensed contract manufacturer experienced in producing nutritional supplements. Labelling will be carried out by Sorridi Therapeutics.
Locations (1)
Sorridi Therapeutics
Northbrook, Illinois, United States