Exploring the human gut microbiome, metabolome and alpha synuclein in health and Parkinson’s disease (PD) – a window to the gut microbiota-brain axis alterations in PD
Trial Snapshot
- Phase
- Not Applicable
- Status
- Not yet recruiting
- Sponsor
- Enrollment
- 125
- Locations
- 2
- Primary Endpoint
- Gut flora differences between Parkinsons disease patients and healthy volunteers
Study Overview
Brief Summary
We plan to conduct a cross-sectional case-control study to identify the alterations in gut microbiota (GM) in Indian patients with Parkinson’s disease (PD) comparing with matched healthy volunteers. The relationship between gut-microbiota alterations and metabolomic profile in other body fluids (stool, urine, blood, saliva) will also be explored to elucidate the role of gut microbiota in the genesis of Parkinson’s disease. This is a cross sectional observational study and no interventions are involved. The patients and healthy subjects will be recruited from SCTIMST, which is a hospital, under the approval of the Ethics Committee of SCTIMST. The biochemical and microbiological investigations on the samples collected from patients and healthy volunteers recruited, will be done in CUSAT which is a science and technology institution (and not a hospital)
Study Design
- Study Type
- Observational
Eligibility Criteria
- Ages
- 60.00 Year(s) to 85.00 Year(s) (—)
- Sex
- All
Inclusion Criteria
- •Inclusion criteria for PD: (1) Diagnosis of PD (according to UKPDS Brain Bank Diagnostic criteria) (2) Early stages of the disease (Hoehn and Yahr stage 2.5 or lesser) (3) Age more than 60 years Inclusion-criteria for healthy volunteer controls : (1) Age and gender matched to PD patients (2) Normal neurological examination.
Exclusion Criteria
- •Exclusion criteria for PD patients: (1) Any other significant neurologic disease, history of alcohol/substance dependence, major psychiatric disorders (including major depression), or any other significant medical illness.
- •(2) Atypical or secondary Parkinsonism.
- •(3) The use of systemic (oral or I/V) antibiotics in the previous 3 months (4) Corticosteroid use (oral, IV, nasal, or inhaled) or use of immune stimulating medications, immunosuppressive agents or large doses of commercial probiotics (5) Major dietary change during previous month (defined as eliminating or significantly increasing a major food group) (6) major GI tract surgery in past 5 years (with the exception of cholecystectomy and appendectomy) (7) Bowel resection at any time (7) active uncontrolled GI disorders or diseases including inflammatory bowel disease (IBD), indeterminate colitis, irritable bowel syndrome (IBS), persistent, infectious gastroenteritis, colitis or gastritis, persistent or chronic diarrhea of unknown etiology Exclusion-Criteria for Healthy volunteers: Same as for PD patients.
Outcomes
Primary Outcomes
Gut flora differences between Parkinsons disease patients and healthy volunteers
Time Frame: At the time of recruitment
Secondary Outcomes
- Metabolomic Profile of biological fluids (Serum, saliva, Urine)(At the time of recruitment)