High Fiber in Parkinson's Disease
Primary Purpose
Parkinson Disease
Status
Recruiting
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
High Fiber supplement
Sponsored by
About this trial
This is an interventional other trial for Parkinson Disease
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
Sites / Locations
- Rutgers-RWJ University HospitalRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
Parkinson's patients
Control subjects
Arm Description
Parkinson's patients who will receive a high fiber supplement
no supplement will be given
Outcomes
Primary Outcome Measures
changes in microbiome composition
Secondary Outcome Measures
Full Information
NCT ID
NCT04976959
First Posted
July 15, 2021
Last Updated
October 24, 2022
Sponsor
Rutgers, The State University of New Jersey
1. Study Identification
Unique Protocol Identification Number
NCT04976959
Brief Title
High Fiber in Parkinson's Disease
Official Title
High Fiber in Parkinson's Disease
Study Type
Interventional
2. Study Status
Record Verification Date
October 2022
Overall Recruitment Status
Recruiting
Study Start Date
July 8, 2021 (Actual)
Primary Completion Date
June 30, 2023 (Anticipated)
Study Completion Date
August 31, 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Rutgers, The State University of New Jersey
4. Oversight
Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Parkinson Disease
7. Study Design
Primary Purpose
Other
Study Phase
Phase 1
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
60 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Parkinson's patients
Arm Type
Experimental
Arm Description
Parkinson's patients who will receive a high fiber supplement
Arm Title
Control subjects
Arm Type
No Intervention
Arm Description
no supplement will be given
Intervention Type
Drug
Intervention Name(s)
High Fiber supplement
Intervention Description
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.
Primary Outcome Measure Information:
Title
changes in microbiome composition
Time Frame
4 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
50 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Gian Pal, MD, MS
Phone
7322357733
Email
gian.pal@rutgers.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Gian Pal, MD, MS
Organizational Affiliation
Rutgers University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Rutgers-RWJ University Hospital
City
New Brunswick
State/Province
New Jersey
ZIP/Postal Code
08901
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Gian Pal
Phone
732-235-7733
Email
gian.pal@rutgers.edu
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
High Fiber in Parkinson's Disease
We'll reach out to this number within 24 hrs