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

Parkinson Disease Clinical Trial

— RESISTA-PD  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02784145
• Other study ID #: RESISTA-PD
• Status: Completed
• Phase: N/A
• Start date: May 2016
• Est. completion date: May 2018

Study information

• Verified date: May 2018
• Source: Saarland University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 95
• Est. completion date: May 2018
• Est. primary completion date: May 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Parkinson Disease

Intervention

Dietary Supplement:
• Resistant starch

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

Locations

Country	Name	City	State
Germany	Saarland University	Homburg / Saar	Saarland

Sponsors (1)

Lead Sponsor	Collaborator
Saarland University

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Bowel habits	Number of patients with improved bowel habits	8 weeks
Primary	Fecal short chain fatty acid (SCFA) concentrations	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)	8 weeks
Primary	Analysis of fecal microbiota composition	Analysis to detect changes between baseline and 8 weeks of resistant starch supplementation	8 weeks