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OpenTrials
Completed

NCT Number: NCT02784145

Effects of Resistant Starch on Bowel Habits, Fecal Short Chain Fatty Acids and Gut Microbiota in Parkinson Disease

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.

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Key information

Conditions

Parkinson Disease Basal Ganglia Diseases Brain Diseases Central Nervous System Diseases Movement Disorders Nervous System Diseases Neurodegenerative Diseases Parkinsonian Disorders Synucleinopathies

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Saarland University

Homburg / Saar, Saarland, 66421, Germany

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Resistant starch

Dietary Supplement

Recommendation with regard to nutrition

Other

Subjects in this arm will receive General recommendations with regard to nutrition based on the guidlines of the German Society for nutrition

Primary outcomes

  1. Bowel habits

    Time frame: 8 weeks

    Number of patients with improved bowel habits

  2. 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)

  3. Analysis of fecal microbiota composition

    Time frame: 8 weeks

    Analysis to detect changes between baseline and 8 weeks of resistant starch supplementation

Sponsors and collaborators

Lead sponsor

Universität des Saarlandes

Other

Registry information

Acronym: RESISTA-PD

Important dates

Study start
2016
Primary completion
2018
Study completion
2018
First posted
May 26, 2016
Registry last updated
May 15, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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