High Fiber in Parkinson's Disease

NCT ID: NCT04976959

Last Updated: 2024-02-26

Basic Information

• Recruitment Status: ACTIVE_NOT_RECRUITING
• Clinical Phase: PHASE1
• Total Enrollment: 60 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-07-08
• Study Completion Date: 2025-08-31

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

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: OTHER
• Blinding Strategy: NONE

Study Groups

Parkinson's patients

Parkinson's patients who will receive a high fiber supplement

Group Type: EXPERIMENTAL

High Fiber supplement

Intervention Type: 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.

Control subjects

no supplement will be given

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

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.

Intervention Type: DRUG

Eligibility Criteria

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

• Minimum Eligible Age: 50 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Rutgers, The State University of New Jersey

OTHER

Sponsor Role: lead

Responsible Party

Gian Dev Pal, MD, MS

Assistant Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Gian Pal, MD, MS

Role: PRINCIPAL_INVESTIGATOR

Rutgers University

Locations

Rutgers-RWJ University Hospital

New Brunswick, New Jersey, United States

Countries

United States

Other Identifiers

Pro2021000121

Identifier Type: -

Identifier Source: org_study_id