Bacteria in the Gut and Parkinsons disease- how are they related - A research study from India

Not Applicable

• Conditions: Health Condition 1: G20- Parkinsons disease

• Registration Number: CTRI/2019/12/022242
• Lead Sponsor: Indian Council of Medical Research ICMR

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 24 November 2021

Recruitment & Eligibility

• Status: ot Yet Recruiting
• Sex: Not specified
• Target Recruitment: 0

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

Study & Design

• Study Type: Observational
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Gut flora differences between Parkinsons disease patients and healthy volunteersTimepoint: At the time of recruitment

Secondary Outcome Measures

Name	Time	Method
Metabolomic Profile of biological fluids (Serum, saliva, Urine)Timepoint: At the time of recruitment