What side effects are associated with this type of intervention?

Common dietary modifications like prebiotics and dietary fibers, including resistant maltodextrin, are generally well-tolerated. However, they can cause gastrointestinal side effects such as bloating, gas, and abdominal discomfort, especially when first introduced or consumed in large amounts. These side effects are typically mild and decrease as the body adjusts to the increased fiber intake.

What prior FDA approvals exist?

The FDA has approved various dietary modifications and related drugs aimed at modulating the gut microbiome and improving gastrointestinal health. For instance, prebiotics like inulin and partially hydrolyzed guar gum have been studied for their benefits in enhancing gut microbiota composition. Probiotics, which include strains like bifidobacteria and lactobacilli, are also commonly used to support gut health. While specific FDA approvals for resistant maltodextrin in the context of gut microbiome modulation are not detailed, similar dietary fibers and prebiotics have been recognized for their safety and efficacy in promoting digestive health.

What other types of research exist?

Promising alternatives to resistant maltodextrin for gut microbiome modulation include: 1) Prebiotic oligosaccharides such as short-chain galacto-oligosaccharides (GOS) and long-chain fructo-oligosaccharides (FOS), which have been shown to increase beneficial gut bacteria. 2) Probiotics like Lactobacillus plantarum and Bifidobacterium animalis subsp lactis, which have demonstrated symptom improvement in gastrointestinal disorders. 3) Synbiotics, which combine prebiotics and probiotics, offering a synergistic effect on gut health. 4) Dietary fibers from whole grains and high-fiber foods, which have been associated with improved gut microbiota composition and colorectal health.

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Dietary Supplement

Resistant Maltodextrin for Gut Microbiome in Parkinson's Disease: Safety and Tolerability Study

Phase 2

Waitlist Available

Led By Roneil G Malkani

Research Sponsored by Northwestern University

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

Summary

This trial will test if a special type of dietary fiber called resistant maltodextrin is safe and can help improve gut health and symptoms in people with Parkinson's disease. The fiber works by feeding good bacteria in the gut.

Who is the study for?

This trial is for men and women aged 60 or older with Parkinson's Disease (PD), who have been on a stable dose of PD medications for at least 30 days. They should be in the early to mid-stages of PD and not have diabetes, unstable health conditions, recent laxative use, cognitive impairment, or be taking certain other treatments.

What is being tested?

The study tests the safety and effects of resistant maltodextrin, a dietary fiber, on gut health and Parkinson's symptoms compared to regular maltodextrin. Participants are randomly assigned to one of these two groups to see if there are any differences.

What are the potential side effects?

While specific side effects aren't listed here, typical concerns with dietary fibers like resistant maltodextrin may include digestive discomfort such as bloating, gas or altered bowel habits.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 4 weeks

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

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Adverse events

Secondary study objectives

Gut microbial remodeling

Trial Design

2Treatment groups

Experimental Treatment

Placebo Group

Group I: Resistant MaltodextrinExperimental Treatment1 Intervention

Resistant maltodextrin (RM) powder 25 g during days 1-7 and 50g during days 8-28, each dose dissolved in 8 oz of water once daily in the morning.

Group II: MaltodextrinPlacebo Group1 Intervention

Maltodextrin 25g for days 1-7 and 50 g for days 8-28, each dose dissolved in 8 oz of water once daily in the morning.

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 dietary modifications like the low FODMAP diet and resistant starches, such as resistant maltodextrin, work by altering the gut environment to reduce gastrointestinal symptoms. The low FODMAP diet limits fermentable short-chain carbohydrates that cause bloating and pain, while resistant starches enhance the production of beneficial microbiome-derived metabolites, improving gut health. These approaches are important as they provide non-drug options to manage symptoms and enhance the quality of life for patients with functional gastrointestinal disorders.

Ingestion of resistant starch by mice markedly increases microbiome-derived metabolites.