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

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 - PRE-PD Study

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

DRKS

Registry ID

DRKS00027061

Enrollment

Registered

2021-11-19

Start date

2019-11-28

Completion date

Unknown

Last updated

2025-04-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

G20

Interventions

Group 1: Short-chain fatty acids (propionic acid, butyric acid) Group 2: 2'-Fucosyllactose (2-Fl) Group 3: Short-chain fatty acids (propionic acid, butyric acid)

2'-fucosyllactose (2-Fl)

Eligibility

Sex/Gender

All

Age

18 Years to 80 Years

Inclusion criteria

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

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

Design outcomes

Primary

Measure	Time frame
1. microbiome diversity and composition 2. fecal and serum metabolome (esp. propionate and butyrate) before and after administration of prebiotics and/or short-chain fatty acids	—

Secondary

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

Measure

Time frame

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

—

Countries

Germany

Contacts

Public ContactTobias Hegelmaier

Abteilung für Neurologie

tobias.hegelmaier@med.ovgu.de0391-67-13431

Outcome results

None listed

Source: DRKS (via WHO ICTRP) · Data processed: Jun 20, 2026