High Fiber in Parkinson's Disease

Parkinson Disease Clinical Trial

Official title:

High Fiber in Parkinson's Disease

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT04976959
• Other study ID #: Pro2021000121
• Status: Active, not recruiting
• Phase: Phase 1
• Start date: July 8, 2021
• Est. completion date: August 31, 2025

Study information

• Verified date: February 2024
• Source: Rutgers, The State University of New Jersey
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 60
• Est. completion date: August 31, 2025
• Est. primary completion date: June 30, 2025
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 50 Years to 75 Years

Eligibility

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

Related Conditions & MeSH terms

• Parkinson Disease

Intervention

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.

Locations

Country	Name	City	State
United States	Rutgers-RWJ University Hospital	New Brunswick	New Jersey

Sponsors (1)

Lead Sponsor	Collaborator
Rutgers, The State University of New Jersey

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	changes in microbiome composition		4 weeks