|
Main
|
|
Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
|
Register:
|
ClinicalTrials.gov |
|
Last refreshed on:
|
11 March 2024 |
|
Main ID: |
NCT03667404 |
|
Date of registration:
|
10/09/2018 |
|
Prospective Registration:
|
Yes |
|
Primary sponsor: |
|
|
Public title:
|
Resistant Maltodextrin for Gut Microbiome in Parkinson's Disease: Safety and Tolerability Study
|
|
Scientific title:
|
Gut Microbial Remodeling With Resistant Maltodextrin for Motor and Non-motor Symptoms in Parkinson's Disease: Safety and Tolerability Study |
|
Date of first enrolment:
|
November 6, 2018 |
|
Target sample size:
|
30 |
|
Recruitment status: |
Active, not recruiting |
|
URL:
|
https://clinicaltrials.gov/ct2/show/NCT03667404 |
|
Study type:
|
Interventional |
|
Study design:
|
Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor).
|
|
Phase:
|
Phase 2
|
|
|
Countries of recruitment
|
|
United States
| | | | | | | |
|
Contacts
|
|
Name:
|
Roneil G Malkani |
|
Address:
|
|
|
Telephone:
|
|
|
Email:
|
|
|
Affiliation:
|
Northwestern Feinberg School of Medicine Department of Neurology |
| | |
|
Key inclusion & exclusion 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.
Age minimum:
60 Years
Age maximum:
N/A
Gender:
All
|
|
Health Condition(s) or Problem(s) studied
|
|
Intestinal Bacteria Flora Disturbance
|
|
Dietary Modification
|
|
Parkinson Disease
|
|
Intervention(s)
|
|
Dietary Supplement: maltodextrin
|
|
Dietary Supplement: Resistant maltodextrin
|
|
Primary Outcome(s)
|
|
Adverse events
[Time Frame: 4 weeks]
|
|
Secondary Outcome(s)
|
|
Gut microbial remodeling
[Time Frame: 4 weeks]
|
|
Secondary ID(s)
|
|
STU00207142
|
|
Source(s) of Monetary Support
|
|
Please refer to primary and secondary sponsors
|
|
Results
|
|
Results available:
|
|
|
Date Posted:
|
|
|
Date Completed:
|
|
|
URL:
|
|
|
|