NCT04512599

Prebiotics in the Parkinson's Disease Microbiome

Completed NA Last updated 3 November 2022

What this trial tests

NA trial testing Prebiotic Bar in Parkinson Disease in 20 participants. Completed in 31 March 2022.

Timeline

31 August 2020

Primary endpoint
31 December 2021

31 March 2022

Quick facts

Lead sponsor	Rush University Medical Center
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	na
Design	single group
Masking	none
Primary purpose	prevention
Enrollment	20
Start date	31 August 2020
Primary completion	31 December 2021
Estimated completion	31 March 2022
Sites	1 location across United States

Drugs / interventions tested

• Prebiotic Bar

Conditions studied

• Parkinson Disease — all drugs for Parkinson Disease →

Sponsor

Rush University Medical Center

Who can join

Eligibility, any sex, with Parkinson Disease. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

8 peer-reviewed publications reference this trial (live from Europe PMC):

1. Microbiota-gut-brain axis and its therapeutic applications in neurodegenerative diseases.
   Loh JS, Mak WQ, Tan LKS, Ng CX, et al · · 2024 · cited 631× · PMID 38360862 · DOI 10.1038/s41392-024-01743-1
2. Probiotics, prebiotics, and postbiotics in health and disease.
   Ji J, Jin W, Liu SJ, Jiao Z, et al · · 2023 · cited 198× · PMID 37929014 · DOI 10.1002/mco2.420
3. An open label, non-randomized study assessing a prebiotic fiber intervention in a small cohort of Parkinson's disease participants.
   Hall DA, Voigt RM, Cantu-Jungles TM, Hamaker B, et al · · 2023 · cited 83× · PMID 36801916 · DOI 10.1038/s41467-023-36497-x
4. The Gut Microbiota in Parkinson Disease: Interactions with Drugs and Potential for Therapeutic Applications.
   Menozzi E, Schapira AHV. · · 2024 · cited 22× · PMID 38570412 · DOI 10.1007/s40263-024-01073-4
5. Inflammatory Animal Models of Parkinson's Disease.
   García-Revilla J, Herrera AJ, de Pablos RM, Venero JL. · · 2022 · cited 22× · PMID 35662128 · DOI 10.3233/jpd-213138
6. From the Gut to the Brain: Is Microbiota a New Paradigm in Parkinson's Disease Treatment?
   Vilela C, Araújo B, Soares-Guedes C, Caridade-Silva R, et al · · 2024 · cited 7× · PMID 38727306 · DOI 10.3390/cells13090770
7. Gut Permeability and Microbiota in Parkinson's Disease: Mechanistic Insights and Experimental Therapeutic Strategies.
   Liang Y, Zhao Y, Fasano A, Su CW. · · 2025 · cited 1× · PMID 41096858 · DOI 10.3390/ijms26199593
8. The gut as a central hub for multi-organ crosstalk in aging.
   Zhang X, Li R, Gao Y, Zhang W, et al · · 2026 · PMID 41787017 · DOI 10.1007/s00018-026-06129-w