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High Fiber supplement for Parkinson's Disease

Phase 1
Waitlist Available
Led By Gian Pal, MD, MS
Research Sponsored by Rutgers, The State University of New Jersey
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 4 weeks
Awards & highlights

Study Summary

This trialwill study how fiber supplements and bacterial transplants may impact PD, helping us understand how changing the microbiome can help humans with PD.

Who is the study for?
This trial is for Parkinson's disease patients who haven't started treatment. It excludes those with significant GI issues affecting motility, acute illnesses needing hospitalization, alcohol misuse, transplant recipients, diabetes, obesity (BMI > 30), dehydration or edema, short bowel syndrome or severe malnutrition, recent use of immunosuppressants or anti-inflammatories, chronic diuretic use, certain occupations like sanitation workers that affect the microbiome; people on parkinsonism-inducing meds; recent antibiotic users; inflammatory bowel disease sufferers; and those with serious liver/kidney/psychiatric/lung diseases or heart failure.Check my eligibility
What is being tested?
The study tests a high-fiber supplement's impact on body microorganisms in Parkinson's patients compared to healthy individuals. It also explores how stool transplants into mice might influence brain health related to Parkinson-like conditions. The goal is to understand if altering the microbiome can benefit humans.See study design
What are the potential side effects?
While not explicitly stated in the provided information about this clinical trial studying a high fiber supplement for Parkinson’s Disease patients may include digestive changes such as bloating, gas discomforts due to increased fiber intake.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~4 weeks
This trial's timeline: 3 weeks for screening, Varies for treatment, and 4 weeks for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
changes in microbiome composition

Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: Parkinson's patientsExperimental Treatment1 Intervention
Parkinson's patients who will receive a high fiber supplement
Group II: Control subjectsActive Control1 Intervention
no supplement will be given

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Logistics

Participation is compensated

You will be compensated for participating in this trial.

Who is running the clinical trial?

Rutgers, The State University of New JerseyLead Sponsor
429 Previous Clinical Trials
64,172 Total Patients Enrolled
Gian Pal, MD, MSPrincipal InvestigatorRutgers University

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is there an upper age limit for enrolment in this experiment?

"This clinical trial seeks individuals aged 50 to 75 years old."

Answered by AI

Has the High Fiber supplement been recognized by the FDA?

"With limited data examining the safety and efficacy of this high fibre supplement, our expert team at Power assigns it a score of 1."

Answered by AI

What is the upper limit of participants in this clinical research endeavor?

"Affirmative, the online platform clinicaltrials.gov has evidence that this study is presently recruiting participants - it was first published on July 8th 2021 and recently modified on October 24th 2022. Sixty patients are needed from a single medical centre to complete the trial."

Answered by AI

To whom does the criteria for enrollment in this clinical trial apply?

"This clinical trial wants to enrol 60 individuals aged 50-75 who suffer from Parkinson's disease and have not yet received any treatment."

Answered by AI

Is this clinical investigation actively recruiting participants?

"According to clinicaltrials.gov, recruitment for this trial is currently ongoing. The initial posting date was July 8th 2021 and the last update happened on October 24th 2022."

Answered by AI

Who else is applying?

What state do they live in?
New Jersey
California
How old are they?
18 - 65
What site did they apply to?
Rutgers-RWJ University Hospital
What portion of applicants met pre-screening criteria?
Met criteria
Did not meet criteria
Recent research and studies
clinicaltrials.govStudy
High Fiber in Parkinson's Disease
Gian Dev Pal, MD, MS 2021. "High Fiber in Parkinson's Disease". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04976959.
All > Parkinsons Disease > Parkinson Disease
~18 spots leftby Jun 2025
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