Clinical trial NCT04976959: High Fiber in Parkinson's Disease
Official title: High Fiber in Parkinson's Disease
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: PHASE1
Conditions: Parkinson Disease
Lead sponsor: Rutgers, The State University of New Jersey
Sponsor class: OTHER
First posted: 2021-07-26
Enrollment: 60
Sex: ALL
Minimum age (years): 50
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

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.


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

Primary outcomes:
measure: changes in microbiome composition
timeFrame: 4 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: New Brunswick
country: United States
facility: Rutgers-RWJ University Hospital
state: New Jersey
Study officials:
affiliation: Rutgers University
name: Gian Pal, MD, MS
role: PRINCIPAL_INVESTIGATOR
References: