Open Label Single Arm Prebiotic Pilot Trial SR001

NCT07127120 | Completed

• 2 other identifiers: SR0011376682
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief 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. 1.To assess the safety and tolerability of consuming 1 fiber bar/day
2. 2.To determine if a prebiotic fiber blend impacts biological metrics and non-motor symptoms of Parkinsons Disease
3. 3.To evaluate the effect of the fiber bar on intestinal inflammation

Conditions

PARKINSON DISEASE (Disorder)

Keywords

Parkinsons; Fiber; prebiotic; inflammation; constipation

Outcome Measures

Primary Outcomes (2)

• Tolerability of Prebiotic Fiber bar in Parkinson's Patients

  The tolerability of consuming 1 fiber bar/day for 4 weeks. Impacts on bowel movement frequency, stool consistency (Bristol Stool Scale), gastrointestinal symptoms of bloating, cramping, flatulence will be evaluated using a GI questionnaire. Measures are reported as # of days, # of events, and severity scale of 1-4. 1=never, 2=infrequent, 3=a few times, 4=often. Values for each metric in the questionnaire will be totaled to achieve an overall GI score. A higher score is indicative of worse GI effects. A decrease in overall score will indicate improvement in GI symptoms, and will be interpreted as tolerability of prebiotic consumption.

  From enrollment to 4 weeks on intervention

• Safety of Prebiotic Fiber bar in Parkinson's Patients

  The safety of consuming 1 fiber bar/day for 4 weeks. Safety will be evaluated based on frequency of adverse events over the course of the study. Potential adverse events could include worsening of gastrointestinal distress and discomfort, changes from baseline blood metabolic measures to abnormal ranges that could indicate liver or kidney dysfunction, diabetes, etc.

  4 weeks

Secondary Outcomes (3)

• Changes in biomarkers of intestinal inflammation

  4 weeks

• Changes in gut microbiome composition

  4 weeks

• Changes in fecal metabolites

  4 weeks

Other Outcomes (3)

• Changes in serum markers of neuroinflammation

  4 weeks

• Impacts on non-motor symptoms associated with Parkinson's Disease

  4 weeks

• Change in symptoms of Parkinson's Disease

  4 weeks

Study Arms (1)

Prebiotic Fiber Bar

EXPERIMENTAL

Open-label consumption of prebiotic fiber bars 1 bar/day for 4 weeks

Dietary Supplement: Prebiotic fiber blend

Interventions

Prebiotic fiber blend DIETARY_SUPPLEMENT

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.

Prebiotic Fiber Bar

Eligibility Criteria

• Age: 60 Years - 75 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Diagnosis of Parkinson's Disease by a Neurologist
• Be able to give written informed consent
• Be aged between 60-75 years
• Participants are on a stable drug regimen
• Willing to consume the study product daily for the duration of the study
• Willing to abstain from pre and probiotics for 2 weeks prior to the study and throughout the 28 days of the intervention

You may not qualify if:

• Participants has acute or chronic gastrointestinal disease (coeliac disease, diarrhea, Crohn's disease, ulcerative colitis, irritable bowel syndrome, diverticulosis, stomach or duodenal ulcers) except for hiatal hernia, gastroesophageal reflux disease, haemorrhoids.
• Participants who have consumed probiotic supplements and prebiotic supplements within 2 weeks prior to Visit 1.
• Participant suffering from severe renal disease (creatinine greater than 2.5 times normal)
• Participants with markedly abnormal liver function (alt/ast greater than 2.5 times normal)
• Plan to have a major change in dietary habits during the study.
• Has any significant acute or chronic coexisting health conditions that would prevent them from fulfilling the study requirements, put the Participant at risk or would confound the interpretation of the study results as judged by the investigator on the basis of medical history and routine laboratory test results.
• Individuals who, in the opinion of the investigator, are considered to be poor attendees or unlikely for any reason to be able to comply with the study.
• Participants may not be receiving treatment involving experimental drugs/supplements. If the Participant has been in a recent experimental study, these must have been completed not less than 90 days for drugs and 30 days for supplements prior to this study.
• Consumption of non-standard diet (vegetarian, vegan, gluten free, or paleo)
• Elevated bilirubin

Sponsors & Collaborators

• Sorridi Therapeutics: lead
• Illinois Institute of Technology, Chicago, USA: collaborator

Study Sites (1)

Sorridi Therapeutics

Northbrook, Illinois, 60062, United States

Location

MeSH Terms

Conditions

Parkinson Disease; Inflammation; Constipation

Condition Hierarchy (Ancestors)

Parkinsonian Disorders; Basal Ganglia Diseases; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Movement Disorders; Synucleinopathies; Neurodegenerative Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Signs and Symptoms, Digestive; Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 8, 2025
• First Posted: August 17, 2025
• Study Start: July 1, 2024
• Primary Completion: July 1, 2025
• Study Completion: April 15, 2026
• Last Updated: April 24, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)