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High Fiber in Parkinson's Disease

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04976959
Recruitment Status : Recruiting
First Posted : July 26, 2021
Last Update Posted : July 26, 2021
Sponsor:
Information provided by (Responsible Party):
Gian Dev Pal, MD, MS, Rutgers, The State University of New Jersey

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.

Condition or disease Intervention/treatment Phase
Parkinson Disease Drug: High Fiber supplement Phase 1

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 60 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Other
Official Title: High Fiber in Parkinson's Disease
Actual Study Start Date : July 8, 2021
Estimated Primary Completion Date : June 30, 2022
Estimated Study Completion Date : August 31, 2022

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Parkinson's patients
Parkinson's patients who will receive a high fiber supplement
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.

No Intervention: Control subjects
no supplement will be given



Primary Outcome Measures :
  1. changes in microbiome composition [ Time Frame: 4 weeks ]


Information from the National Library of Medicine

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Ages Eligible for Study:   50 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04976959


Contacts
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Contact: Gian Pal, MD, MS 7322357733 gian.pal@rutgers.edu

Locations
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United States, New Jersey
Rutgers-RWJ University Hospital Recruiting
New Brunswick, New Jersey, United States, 08901
Contact: Gian Pal    732-235-7733    gian.pal@rutgers.edu   
Sponsors and Collaborators
Rutgers, The State University of New Jersey
Investigators
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Principal Investigator: Gian Pal, MD, MS Rutgers University
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Responsible Party: Gian Dev Pal, MD, MS, Assistant Professor, Rutgers, The State University of New Jersey
ClinicalTrials.gov Identifier: NCT04976959    
Other Study ID Numbers: Pro2021000121
First Posted: July 26, 2021    Key Record Dates
Last Update Posted: July 26, 2021
Last Verified: July 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Parkinson Disease
Parkinsonian Disorders
Basal Ganglia Diseases
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Movement Disorders
Synucleinopathies
Neurodegenerative Diseases