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

Active Not RecruitingPhase 2

Sponsor: Northwestern University

Conditions: Parkinson Disease, Intestinal Bacteria Flora Disturbance, Dietary Modification

Interventions: Resistant maltodextrin, maltodextrin

Countries: United States

This study will evaluate the safety and tolerability of a dietary fiber, resistant maltodextrin, in people with Parkinson's disease. It will also evaluate the fiber's effect on the gut microbiome and potential effects on motor function and non-motor functions. Half of the participants will receive resistant maltodextrin and the other half will receive a control substance, maltodextrin.

Eligibility overview

Sex: ALL

Age: 60 Years to —

Healthy volunteers: No

Study type: INTERVENTIONAL

Eligibility criteria

Inclusion Criteria:

* Men and women age ≥60 years
* Diagnosis of PD based on United Kingdom PD brain bank criteria, Hoehn and Yahr stage 1-3.
* Stable dose of PD medications for 30 days prior to study and for duration of study
* If used, stable dose of melatonin, sedative/hypnotic or stimulant medications

Exclusion Criteria:

* use of other prebiotic or probiotic treatment for 30 days prior to or during the study
* unstable medical or psychiatric disorder
* history of diabetes mellitus or current use of medication for diabetes
* cognitive impairment based on Montreal Cognitive Assessment (MoCA) \<25.
* current or recent (within previous 3 weeks) use of laxatives
* use of antibiotics in the past 30 days
* participation in another clinical trial in the past 30 days.

Locations (1)

Chicago, Illinois, United States