NCT07127120Completed
Open Label Single Arm Prebiotic Pilot Trial SR001
A Single Arm, Open Label Study to Assess the Tolerability of a Prebiotic in Adults With Parkinson's Disease and Healthy Adults
Source: ClinicalTrials.gov · Last updated 24 Apr 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Completed
- Study type
- Interventional
- Enrollment
- 20 (actual)
- First submitted
- 8 Aug 2025
- Start date
- 1 Jul 2024
- Primary completion date
- 1 Jul 2025
- Lead sponsor
- Sorridi Therapeutics
- Diseases
- Parkinson disease
- NCT number
- NCT07127120
What you commit to
- Study type: Interventional
- Participants enrolled: 20
- From 1 Jul 2024 to the primary completion date, 1 Jul 2025
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Participants who have consumed probiotic supplements and prebiotic supplements within 2 weeks prior to Visit 1.
- 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.
Other illness
- 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.
Lab values
- 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)
- 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.
- Elevated bilirubin
Other
- Plan to have a major change in dietary habits during the study.
- 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.
- Consumption of non-standard diet (vegetarian, vegan, gluten free, or paleo)
Who the study is looking for
- 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
Age in the registry: 60 years to 75 years · Sex: All · Accepts healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Sorridi Therapeutics Coordinator of this site? Confirm its status | Northbrook | United States | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.