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Effects of Resistant Starch on Bowel Habits, Fecal Short Chain Fatty Acids and Gut Microbiota in Parkinson Disease (RESISTA-PD)

This study is currently recruiting participants.
Verified August 2017 by Dr. Marcus Unger, Saarland University
Sponsor:
ClinicalTrials.gov Identifier:
NCT02784145
First Posted: May 26, 2016
Last Update Posted: August 24, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
Information provided by (Responsible Party):
Dr. Marcus Unger, Saarland University
  Purpose

The investigators will investigate the effects of an 8-week resistant starch (RS) supplementation (5 g twice a day) in patients with Parkinson Disease and matched controls on:

  1. symptoms of constipation (assessed by clinical scores);
  2. fecal short chain fatty acid concentrations (measured by chromatography);
  3. gut microbiota composition.

Condition Intervention
Parkinson Disease Dietary Supplement: Resistant starch Other: Recommendation with regard to nutrition

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Other
Official Title: Effects of Resistant Starch on Bowel Habits, Fecal Short Chain Fatty Acids and Gut Microbiota in Parkinson Disease

Resource links provided by NLM:


Further study details as provided by Dr. Marcus Unger, Saarland University:

Primary Outcome Measures:
  • Bowel habits [ Time Frame: 8 weeks ]
    Number of patients with improved bowel habits

  • Fecal short chain fatty acid (SCFA) concentrations [ Time Frame: 8 weeks ]
    Number of patients with either a) increased, b.) unaltered or c) decreased concentration of short chain fatty acids in fecal samples at 8 weeks (compared to baseline)

  • Analysis of fecal microbiota composition [ Time Frame: 8 weeks ]
    Analysis to detect changes between baseline and 8 weeks of resistant starch supplementation


Estimated Enrollment: 90
Study Start Date: May 2016
Estimated Study Completion Date: December 2018
Estimated Primary Completion Date: June 2018 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
RS
Resistant starch supplementation (5 g twice a day)
Dietary Supplement: Resistant starch
No RS
PD patients who do not receive resistant starch, but who receive recommendations concerning healthy Nutrition (based on the guidelines of the German Society for Nutrition)
Other: Recommendation with regard to nutrition
Subjects in this arm will receive General recommendations with regard to nutrition based on the guidlines of the German Society for nutrition

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02784145


Contacts
Contact: Marcus M. Unger, PD Dr. med. + 49 6841 16 24322 marcus.unger@uks.eu

Locations
Germany
Saarland University Recruiting
Homburg / Saar, Saarland, Germany, 66421
Contact: Marcus M Unger, MD    +49 6841 16 24322    marcus.unger@uks.eu   
Principal Investigator: Marcus M Unger, MD         
Sponsors and Collaborators
Saarland University
Investigators
Principal Investigator: Marcus M Unger, PD Dr. med. Saarladnd University, Department of Neurology
  More Information

Responsible Party: Dr. Marcus Unger, PD Dr., Saarland University
ClinicalTrials.gov Identifier: NCT02784145     History of Changes
Other Study ID Numbers: RESISTA-PD
First Submitted: May 17, 2016
First Posted: May 26, 2016
Last Update Posted: August 24, 2017
Last Verified: August 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes

Additional relevant MeSH terms:
Parkinson Disease
Parkinsonian Disorders
Basal Ganglia Diseases
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Movement Disorders
Neurodegenerative Diseases