Open Label Single Arm Prebiotic Pilot Trial SR001
NCT07127120 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 20
Last updated 2026-04-24
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.
Conditions
- PARKINSON DISEASE (Disorder)
Interventions
- DIETARY_SUPPLEMENT
-
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.
Sponsors & Collaborators
-
Illinois Institute of Technology, Chicago, USA
collaborator UNKNOWN -
Sorridi Therapeutics
lead INDUSTRY
Study Design
- Allocation
- NA
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- SINGLE_GROUP
Eligibility
- Min Age
- 60 Years
- Max Age
- 75 Years
- Sex
- ALL
- Healthy Volunteers
- Yes
Timeline & Regulatory
- Start
- 2024-07-01
- Primary Completion
- 2025-07-01
- Completion
- 2026-04-15
Countries
- United States
Study Locations
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