Open Label Single Arm Prebiotic Pilot Trial SR001
Completed · Not applicable
Conditions studied: PARKINSON DISEASE (Disorder)
In brief
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.
Key facts
- Study ID
- NCT07127120
- Run by
- Sorridi Therapeutics
- People needed
- 20
- Starts
- 2024-07-01
- Expected to finish
- 2026-04-15
- Last updated by the study team
- 2026-04-24
Who can join
Age: 60 and older, up to 75. Sex: any. Healthy volunteers: accepted.
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
Where it is running
- Sorridi Therapeutics — Northbrook, Illinois, United States
Full record on ClinicalTrials.gov
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