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:
|
12 December 2020 |
Main ID: |
NCT02784145 |
Date of registration:
|
17/05/2016 |
Prospective Registration:
|
No |
Primary sponsor: |
|
Public title:
|
Effects of Resistant Starch on Bowel Habits, Fecal Short Chain Fatty Acids and Gut Microbiota in Parkinson Disease
RESISTA-PD |
Scientific title:
|
Effects of Resistant Starch on Bowel Habits, Fecal Short Chain Fatty Acids and Gut Microbiota in Parkinson Disease |
Date of first enrolment:
|
May 2016 |
Target sample size:
|
95 |
Recruitment status: |
Completed |
URL:
|
https://clinicaltrials.gov/show/NCT02784145 |
Study type:
|
Interventional |
Study design:
|
Allocation: Non-Randomized. Intervention model: Parallel Assignment. Primary purpose: Other. Masking: None (Open Label).
|
Phase:
|
N/A
|
|
Countries of recruitment
|
Germany
| | | | | | | |
Contacts
|
Name:
|
Marcus M Unger, PD Dr. med. |
Address:
|
|
Telephone:
|
|
Email:
|
|
Affiliation:
|
Saarladnd University, Department of Neurology |
| | |
Key inclusion & exclusion criteria
|
Main Inclusion Criteria:
- Written informed to participate
- For patients: diagnosis of Parkinson Disease
Main Exclusion Criteria:
- Use of antibiotics, steroids or probiotic supplements
- Chronic or acute disorders of the gastrointestinal tract
- History of gastrointestinal surgery (other than appendectomy)
- For healthy controls: Family history of neurodegenerative disorders
Age minimum:
18 Years
Age maximum:
N/A
Gender:
All
|
Health Condition(s) or Problem(s) studied
|
Parkinson Disease
|
Intervention(s)
|
Other: Recommendation with regard to nutrition
|
Dietary Supplement: Resistant starch
|
Primary Outcome(s)
|
Analysis of fecal microbiota composition
[Time Frame: 8 weeks]
|
Fecal short chain fatty acid (SCFA) concentrations
[Time Frame: 8 weeks]
|
Bowel habits
[Time Frame: 8 weeks]
|
Secondary ID(s)
|
RESISTA-PD
|
Source(s) of Monetary Support
|
Please refer to primary and secondary sponsors
|
Results
|
Results available:
|
|
Date Posted:
|
|
Date Completed:
|
|
URL:
|
|
|
|