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NCT04512599 · ClinicalTrials.gov registry record · NA

Prebiotics in the Parkinson's Disease Microbiome

A NA study, sponsored by Rush University Medical Center.

Completed
Registry status
NA
Development phase
20
Enrollment target

NCT04512599 is a NA study that has completed, run by Rush University Medical Center. The registered enrollment target is 20 participants.

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The verdict

NCT04512599, a NA study, has completed, sponsored by Rush University Medical Center.

COMPLETED
Registry status
NA
Development phase
20 participants
Enrollment target

Study Summary

There are about one million Parkinson's disease (PD) patients in America. The risks associated with whether or not an individual may develop PD include environment and genetic (biologic, hereditary) factors. Studies have show that certain things may be triggers, for example cells in the brain that are made active and associated inflammation in the brain. The gut is the largest interface between the PD patient and the environment, and it is highly thought to be pathway to the environment trigger. Research studies have looked at how information is passed back and forth between the brain and the gut. The goal of this study (pilot) is to gather information to conduct a larger clinical trial. For this pilot study is to determine if a microbiota-directed (bacteria in the gut) intervention (dietary bar) is capable of correcting the bacteria gut balance in PD. This is based on the thought that an imbalance of bacteria in the gut of PD patients may lead to the gut and intestines working correctly. The long term goal is to see if the intervention has the potential to modify the disease or protect the brain in PD. If the intervention successfully improves the bacterial imbalance in PD, it will be the first attempt to modify the Gut-Brain communication in PD, which can lead to additional studies aimed at improving the disease progression or prevention. In this project, the investigators will test how well Parkinson's disease patients tolerate changes in the gut and intestines by providing the participants a dietary bar to eat for 10 days. The investigators intend to conduct this pilot clinical trial in which the investigators believe that daily oral intake of a "prebiotic" mixture will be safe and well tolerated in a small number Parkinson's disease participants prior to a larger clinical trial looking at efficacy.

Interventions

  • OTHER Prebiotic Bar

Trial Details

FieldValue
Enrollment Target 20 participants
Start Date 2020-08-31
Est. Completion 2022-03-31
Phase NA

Sponsor

Rush University Medical Center

320 total trials

What the Registry Record Tells You About NCT04512599

The ClinicalTrials.gov registry entry for NCT04512599 describes a study currently listed as completed, categorized as NA. The registered enrollment target is 20 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Rush University Medical Center, which has 320 total studies on file at ClinicalTrials.gov.

The record links to 0 conditions, and to 1 intervention - of which Prebiotic Bar is the first listed.

NCT04512599 reports 0 study locations.

Frequently Asked Questions

What is clinical trial NCT04512599 about?

NCT04512599 is a clinical study titled "Prebiotics in the Parkinson's Disease Microbiome". There are about one million Parkinson's disease (PD) patients in America. The risks associated with whether or not an individual may develop PD include environment and genetic (biologic, hereditary) factors. Studies have show that certain things may be triggers, for example cells in the brain that a...

What is the current status of trial NCT04512599?

This trial is currently completed. It is a NA study. The enrollment target is 20 participants. The study started on 2020-08-31. Estimated completion is 2022-03-31.

What interventions are being tested in trial NCT04512599?

The interventions under investigation include: Prebiotic Bar (OTHER).

Who is sponsoring clinical trial NCT04512599?

This trial is sponsored by Rush University Medical Center, which has 320 total clinical trials registered on ClinicalTrials.gov.

Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial

Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.