NCT03667404Active, not recruitingPhase 2
Resistant Maltodextrin for Gut Microbiome in Parkinson's Disease: Safety and Tolerability Study
Gut Microbial Remodeling With Resistant Maltodextrin for Motor and Non-motor Symptoms in Parkinson's Disease: Safety and Tolerability Study
Source: ClinicalTrials.gov · Last updated 15 Apr 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Active, not recruiting
- Phase (registry)
- Phase 2
- Study type
- Interventional
- Enrollment
- 30 (estimated)
- First submitted
- 10 Sept 2018
- Start date
- 6 Nov 2018
- Primary completion date
- 30 Jun 2022
- Lead sponsor
- Northwestern University
- Diseases
- Parkinson disease
- NCT number
- NCT03667404
What you commit to
- Study type: Interventional · Phase 2
- Planned participants: 30
- From 6 Nov 2018 to the primary completion date, 30 Jun 2022
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- use of other prebiotic or probiotic treatment for 30 days prior to or during the study
- current or recent (within previous 3 weeks) use of laxatives
Other illness
- 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.
Other
- use of antibiotics in the past 30 days
- participation in another clinical trial in the past 30 days.
Who the study is looking for
- 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
Age in the registry: 60 years to - · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Northwestern University Coordinator of this site? Confirm its status | Chicago | United States | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.