Analysis of changes in the gut microbiome, and dosing of dopaminergic therapy under supplementation of short-chain fatty acids and prebiotics as dietary supplements in the context of PD

Phase 2

• Conditions: G20; Parkinson disease

• Registration Number: DRKS00027061
• Lead Sponsor: BASF SE

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Completion: 2021-10-24
• Study Start: 2021-11-19
• Last Update Posted: 19 August 2024

Recruitment & Eligibility

• Status: Complete
• Sex: All
• Target Recruitment: 80

Inclusion Criteria

1. age at PD: 18-90 years
2. primary Parkinson's syndrome
3. moderate disease severity (stable daily levodopa dose 500-850 mg daily)
4. full orientation to time, place and person
5. sufficient knowledge of German (able to give informed consent)
6. independent mobility without, with unilateral or bilateral walking assistance

Exclusion Criteria

1. poor general condition
2. pregnancy
3. severe concomitant disease or organ dysfunction (heart failure, NYHA stages III-IV, severe respiratory failure (e.g., with resting dyspnea), irreversible multiorgan failure, sepsis, acute viral hepatitis)
4. serious previous diseases of the gastrointestinal tract
5. malignancy (current or history with current follow-up/treatment)
6. illness or medical treatment incompatible with study participation (pending surgical procedure, etc.)
7. immunosuppressive therapy in the last 6 months (e.g. mitoxantrone, azathioprine, cyclophosphamide, MTX)
8. intake of antibiotics or metformin during the past 3 months
9. vegan dietary habits

Study & Design

• Study Type: interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
1. microbiome diversity and composition<br>2. fecal and serum metabolome (esp. propionate and butyrate) before and after administration of prebiotics and/or short-chain fatty acids

Secondary Outcome Measures

Name	Time	Method
1. neuropsychological testing by means of standardized questionnaires (BDI-II, PANDA)<br>2. neurophysiological diagnostics (MLS)<br>3. olfactory testing<br>4. blood pressure testing and adaptation as expression of vegetative functions (Schellong test, medication documentation)<br>5. clinical-quantifiable parameters (UPDRS, walking distance, dose of necessary parkinsonian medication)<br>6. recording of changes in stool consistency and defecation habits by means of a standardized questionnaire (stool questionnaire)<br>7. recording of dietary habits and changes during the course by means of a standardized questionnaire (dietary questionnaire)