High Fiber in Parkinson's Disease

NCT04976959 | Active Not Recruiting Phase 1 FDA Drug

• 1 other identifier: Pro2021000121
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Parkinson Disease

Outcome Measures

Primary Outcomes (1)

• changes in microbiome composition

  4 weeks

Study Arms (2)

Parkinson's patients

EXPERIMENTAL

Parkinson's patients who will receive a high fiber supplement

Drug: High Fiber supplement

Control subjects

NO INTERVENTION

no supplement will be given

Interventions

High Fiber supplement DRUG

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.

Parkinson's patients

Eligibility Criteria

• Age: 50 Years - 75 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Parkinson's disease patients who are untreated

You may not qualify if:

• 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;

Sponsors & Collaborators

• Rutgers, The State University of New Jersey: lead

Study Sites (1)

Rutgers-RWJ University Hospital

New Brunswick, New Jersey, 08901, United States

Location

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

• Gian Pal, MD, MS

  Rutgers University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: July 15, 2021
• First Posted: July 26, 2021
• Study Start: July 8, 2021
• Primary Completion: June 30, 2025
• Study Completion: August 31, 2025
• Last Updated: February 26, 2024

Record last verified: 2024-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)