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NCT07127120 · ClinicalTrials.gov registry record · NA
Open Label Single Arm Prebiotic Pilot Trial SR001
A NA study of PARKINSON DISEASE (Disorder), sponsored by Sorridi Therapeutics.
- Active
- Registry status
- NA
- Development phase
- 20
- Enrollment target
- 1
- Study location
NCT07127120: Active NA study of PARKINSON DISEASE (Disorder), sponsored by Sorridi Therapeutics.
NCT07127120 is a NA study of PARKINSON DISEASE (Disorder) that is active but no longer recruiting, run by Sorridi Therapeutics. The registered enrollment target is 20 participants, below the 41-participant average among 5 other PARKINSON DISEASE (Disorder) trials with a reported enrollment target (51% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT07127120, a NA study of PARKINSON DISEASE (Disorder), is active but no longer recruiting, sponsored by Sorridi Therapeutics.
- ACTIVE NOT RECRUITING
- Registry status
- NA
- Development phase
- 20 participants
- Enrollment target
- 1
- Study location
Study 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.
Primary Outcome
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 eff
Conditions Studied
Interventions
- DIETARY_SUPPLEMENT Prebiotic fiber blend
Study Locations (1)
Illinois
- Sorridi Therapeutics - Northbrook
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 20 participants |
| Start Date | 2024-07-01 |
| Est. Completion | 2025-11 |
| Phase | NA |
What the registry record for NCT07127120 still lists
NCT07127120 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 20 participants, a relatively small participant target, below the 41-participant average among 5 other PARKINSON DISEASE (Disorder) trials with a reported enrollment target (51% lower).
The record links to 1 condition, with PARKINSON DISEASE (Disorder) appearing as the primary indexed condition, and to 1 intervention - of which Prebiotic fiber blend is the first listed.
NCT07127120 reports a single indexed study location in Illinois.
Frequently Asked Questions
What is clinical trial NCT07127120 about?
NCT07127120 is a clinical study titled "Open Label Single Arm Prebiotic Pilot Trial SR001". 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...
What is the current status of trial NCT07127120?
This trial is currently active not recruiting. It is a NA study. The enrollment target is 20 participants. The study started on 2024-07-01. Estimated completion is 2025-11.
What conditions does trial NCT07127120 study?
This clinical trial studies the following conditions: PARKINSON DISEASE (Disorder).
What interventions are being tested in trial NCT07127120?
The interventions under investigation include: Prebiotic fiber blend (DIETARY_SUPPLEMENT).
Who is sponsoring clinical trial NCT07127120?
This trial is sponsored by Sorridi Therapeutics, which has 1 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT07127120 being conducted?
This trial has 1 study location across Illinois. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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