Prebiotics in the Parkinson's Disease Microbiome

NCT04512599 | Completed

• 1 other identifier: ORA20072703
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Parkinson Disease

Keywords

microbiome; prebiotic

Outcome Measures

Primary Outcomes (1)

• Tolerability of prebiotic bar after 10 days in PD participants

  Tolerability of the prebiotic bar will be assessed for change in the GI Symptoms and Severity Checklist at 10 days from baseline

  10 days

Secondary Outcomes (1)

• Safety of prebiotic bar during 10 days in Parkinson's disease participants

  10 days

Other Outcomes (5)

• Changes in the relative abundance of SCFA-producing bacteria

  10 days

• Changes in intestinal barrier integrity

  10 days

• Changes in brain health

  10 days

Study Arms (1)

Single Arm

EXPERIMENTAL

Open-label consumption of prebiotic bar(s); 1 bar for 3 days; followed by 2 bars for 7 days

Other: Prebiotic Bar

Interventions

Prebiotic Bar OTHER

The prebiotic bar is a proprietary formula created by the study co-investigators, who will not be involved in participant recruitment, selection or outcome measures.The prebiotic bars will be shipped and stored at room temperature prior to consumption.

Single Arm

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Clinical diagnosis of Parkinson's disease,
• \>age 30,
• Must be able to consent

You may not qualify if:

• prior intestinal resection,
• patient history of GI diseases except for hiatal hernia, gastroesophageal reflux disease, hemorrhoids,
• severe renal disease defined by creatinine more than 2 ½ times normal,
• markedly abnormal liver function defined by liver function tests over 4 times normal levels or elevated bilirubin,
• antibiotic use within the last 12 weeks prior to enrollment,
• a plan to have a major change in dietary habit during the study,
• consumption of probiotics, prebiotics or synbiotics without an appropriate 2 week washout period

Sponsors & Collaborators

• Rush University Medical Center: lead

Study Sites (1)

Rush University Medical Cener

Chicago, Illinois, 60612, United States

Location

Related Publications (1)

• Hall DA, Voigt RM, Cantu-Jungles TM, Hamaker B, Engen PA, Shaikh M, Raeisi S, Green SJ, Naqib A, Forsyth CB, Chen T, Manfready R, Ouyang B, Rasmussen HE, Sedghi S, Goetz CG, Keshavarzian A. An open label, non-randomized study assessing a prebiotic fiber intervention in a small cohort of Parkinson's disease participants. Nat Commun. 2023 Feb 18;14(1):926. doi: 10.1038/s41467-023-36497-x.

  PMID: 36801916 DERIVED

MeSH Terms

Conditions

Parkinson Disease

Condition Hierarchy (Ancestors)

Parkinsonian Disorders; Basal Ganglia Diseases; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Movement Disorders; Synucleinopathies; Neurodegenerative Diseases

Study Officials

• Deborah A Hall, MD PhD

  Rush University Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Neurological Sciences

Model Details: The study is an open-label, non-randomized study in Parkinson's disease participants

Study Record Dates

• First Submitted: July 31, 2020
• First Posted: August 13, 2020
• Study Start: August 31, 2020
• Primary Completion: December 31, 2021
• Study Completion: March 31, 2022
• Last Updated: November 3, 2022

Record last verified: 2022-11

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)