High Fiber in Parkinson's Disease

Rutgers The State University of New Jersey

Status and phase

Active, not recruiting

Phase 1

Conditions

Parkinson Disease

Treatments

Drug: High Fiber supplement

Study type

Interventional

Funder types

Other

Identifiers

NCT04976959

Pro2021000121

Details and patient eligibility

About

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.

Enrollment

60 estimated patients

Sex

All

Ages

50 to 75 years old

Volunteers

Accepts Healthy Volunteers

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