High Fiber in Parkinson's Disease

The purpose of the research is to determine the effects of a high-fiber nutritional supplement (HFS) on the bacteria, viruses, and fungi that live in different regions of the body in those with Parkinson's disease (PD). We will compare the bacteria, viruses, and fungi of those with PD to those without PD (healthy controls). We will also examine the effects of transplanting stool from humans into laboratory mice with or without Parkinson-like pathology to understand how the microbiome influences the brains of animals. We can use this information to get a better understanding of how changing the microbiome might help humans.

Study Overview

• Status: Active, not recruiting
• Conditions: Parkinson Disease
• Intervention / Treatment: Drug: High Fiber supplement

• Study Type: Interventional
• Enrollment (Estimated): 60
• Phase: Phase 1

Contacts and Locations

Study Locations

• United States
  • New Jersey
    • New Brunswick, New Jersey, United States, 08901
      • Rutgers-RWJ University Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 50 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

• Parkinson's disease patients who are untreated

Exclusion Criteria:

• Occupation expected to change the microbiome (e.g. sanitation worker)
• Treatment with medications that may induce parkinsonism (e.g. metoclopramide, typical or atypical antipsychotic agents)
• Treatment within 12 weeks with oral or intravenous antibiotics
• Known diagnosis of inflammatory bowel disease
• Symptomatic organic gastrointestinal (GI) disease (other than hemorrhoids and hiatal hernia) or abdominal surgeries for symptomatic gastrointestinal disease such as bowel resection, diverticular surgery, colostomy; subjects with a history of an appendectomy or gallbladder removal for non-cancerous disease more than 5 years prior to presentation are allowed.
• Symptomatic functional GI disease that significantly impairs intestinal motility such as scleroderma or use of GI motility drugs
• Acute illness requiring immediate hospitalization
• Pre-existent conditions as below:
• Liver disease (cirrhosis or persistently abnormal AST or ALT that are 2X> normal);
• Kidney disease (creatinine>2.0 mg/dL);
• Uncontrolled psychiatric illness;
• Clinically important lung disease or heart failure;
• HIV disease;
• Alcoholism, unreliable drinking history; or consumption of alcohol more than 3 times a week or binge drinking or drinking more than or equal to 3 drinks per occasion;
• Transplant recipients;
• Diabetes;
• BMI > 30
• Clinically significant dehydration or clinically detectable ascites or peripheral edema or cardiac failure
• Presence of short bowel syndrome or severe malnutrition with ideal body weight < or = 90%
• Use of immunosuppressive medications in 3 months prior to enrollment
• Anti-inflammatory medication use within 3 weeks of enrollment.
• Chronic use of diuretics

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Non-Randomized
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Parkinson's patients; Parkinson's patients who will receive a high fiber supplement	Drug: High Fiber supplement; The supplement consists of a mixture of soluble fibers (from inulin and fibersol-2) and insoluble fibers (from oat bran, corn bran, wheat bran and sorghum bran) and it will be consumed as a drink.
No Intervention: Control subjects; no supplement will be given

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
changes in microbiome composition	4 weeks

Collaborators and Investigators

• Sponsor: Rutgers, The State University of New Jersey
• Investigators: Principal Investigator: Gian Pal, MD, MS, Rutgers University

Study record dates

Study Major Dates

• Study Start (Actual): July 8, 2021
• Primary Completion (Estimated): June 30, 2025
• Study Completion (Estimated): August 31, 2025

Study Registration Dates

• First Submitted: July 15, 2021
• First Submitted That Met QC Criteria: July 15, 2021
• First Posted (Actual): July 26, 2021

Study Record Updates

• Last Update Posted (Estimated): February 26, 2024
• Last Update Submitted That Met QC Criteria: February 22, 2024
• Last Verified: February 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Parkinsonian Disorders; Basal Ganglia Diseases; Movement Disorders; Synucleinopathies; Neurodegenerative Diseases; Parkinson Disease
• Other Study ID Numbers: Pro2021000121

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No