What side effects are associated with this type of intervention?

Common treatments for Parkinson's Disease (PD) that target the gut microbiome, such as high-fiber nutritional supplements and probiotics, aim to improve gut health and potentially alleviate PD symptoms. However, these treatments can have side effects. High-fiber supplements may cause bloating, gas, and abdominal discomfort, especially when first introduced. Probiotics can also lead to similar gastrointestinal symptoms, including gas and bloating. It's important for patients to start these treatments at low doses and gradually increase them to minimize side effects. Consulting with a healthcare provider is essential to tailor the treatment to individual needs and monitor for any adverse effects.

What prior FDA approvals exist?

FDA-approved treatments for Parkinson's Disease primarily include pharmacologic therapies such as levodopa, dopamine agonists, and MAO-B inhibitors, which focus on managing motor symptoms by increasing dopamine levels or mimicking its action. While there is growing interest in the role of the gut microbiome in PD, specific FDA-approved treatments targeting this aspect are limited. However, research into probiotics and high-fiber diets, like the High-Fiber Nutritional Supplement (HFS) trial, is ongoing to explore their potential benefits in modulating the gut microbiome and alleviating PD symptoms.

What other types of research exist?

Promising novel alternatives to High-Fiber Nutritional Supplement (HFS) for Parkinson's Disease patients include: 1) Probiotics: Specific strains like Lactobacillus and Bifidobacterium have shown potential in modulating the gut microbiome and improving symptoms. 2) Fecal Microbiota Transplantation (FMT): Though still under research, FMT has shown promise in altering gut microbiota composition and improving neurological outcomes. 3) Synbiotics: Combining probiotics and prebiotics to enhance gut health and potentially alleviate PD symptoms. 4) Omega-3 Fatty Acids: While not directly modulating the microbiome, they have anti-inflammatory properties that may benefit PD patients. These alternatives should be discussed with a healthcare provider to determine the best individualized treatment plan.

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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 up to 5 years

Awards & highlights

No Placebo-Only Group

Summary

This trial is testing a high-fiber supplement to see if it can change the microorganisms in people with Parkinson's disease and study how these changes might affect brain health.

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.

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.

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 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 5 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 5 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 5 years for reporting.

Treatment Details

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

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

Do I qualify?Apply below to find out

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

Common treatments for Parkinson's Disease (PD) include medications like Levodopa, which replenishes dopamine levels in the brain, and dopamine agonists, which mimic dopamine's effects. Additionally, treatments that modulate the gut microbiome, such as high-fiber diets and probiotics, are being studied for their potential to influence brain health through the gut-brain axis. These treatments matter for PD patients because they offer a holistic approach to managing symptoms and potentially slowing disease progression by addressing both neurological and gastrointestinal aspects of the disease.

Probiotic Clostridium butyricum ameliorated motor deficits in a mouse model of Parkinson's disease via gut microbiota-GLP-1 pathway.Probiotics Alleviate the Progressive Deterioration of Motor Functions in a Mouse Model of Parkinson's Disease.