| CTRI Number |
CTRI/2019/12/022242 [Registered on: 03/12/2019] Trial Registered Prospectively |
| Last Modified On: |
27/11/2019 |
| Post Graduate Thesis |
No |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Other |
|
Public Title of Study
|
Bacteria in the Gut and Parkinsons disease- how are they related - A research study from India |
|
Scientific Title of Study
|
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 Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
| NIL |
Other |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Syam Krishnan Nair |
| Designation |
Additional Professor of Neurology |
| Affiliation |
Sree Chitra Tirunal Institute for Medical Sciences and Technology |
| Address |
Additional Professor of Neurology, Sree Chitra Tirunal Institute for Medical Sciences and Technology, Thiruvananthapuram, Kerala , India.
Thiruvananthapuram
KERALA
695011
India |
| Phone |
0471-2524268 |
| Fax |
|
| Email |
drsyam@sctimst.ac.in |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Syam Krishnan Nair |
| Designation |
Additional Professor of Neurology |
| Affiliation |
Sree Chitra Tirunal Institute for Medical Sciences and Technology |
| Address |
Additional Professor of Neurology, Sree Chitra Tirunal Institute for Medical Sciences and Technology, Thiruvananthapuram, Kerala , India.
Thiruvananthapuram
KERALA
695011
India |
| Phone |
0471-2524268 |
| Fax |
|
| Email |
drsyam@sctimst.ac.in |
|
Details of Contact Person
Public Query
|
| Name |
Dr Syam Krishnan Nair |
| Designation |
Additional Professor of Neurology |
| Affiliation |
Sree Chitra Tirunal Institute for Medical Sciences and Technology |
| Address |
Additional Professor of Neurology, Sree Chitra Tirunal Institute for Medical Sciences and Technology, Thiruvananthapuram, Kerala , India.
Thiruvananthapuram
KERALA
695011
India |
| Phone |
0471-2524268 |
| Fax |
|
| Email |
drsyam@sctimst.ac.in |
|
|
Source of Monetary or Material Support
|
| Indian Council of Medical Research (ICMR) |
|
|
Primary Sponsor
|
| Name |
Indian Council of Medical Research ICMR |
| Address |
Post Box No: 4911, Ansari Nagar, New Delhi, PIN 110029 |
| Type of Sponsor |
Government funding agency |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 2 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Baby Chakrapani |
Cochin University of Science and Technology (CUSAT) |
Room Number 1 (Director), Center for Neurosciences,
Department of Biotechnology, CUSAT, Cochin University PO, Cochin, Ernakulam District, Kerala, PIN 682022
Ernakulam
KERALA |
9495109908
bcps80@gmail.com |
| Dr Syam Krishnan Nair |
Sree Chitra Tirunal Institute for Medical Sciences and Technology (SCTIMST) |
Room Number 2404, Comprehensive Care Center for Movement Disorders, Department of Neurology, SCTIMST, Medical College PO, Thiruvananthapuram, Kerala , India PIN 695011
Thiruvananthapuram
KERALA |
0471-2524262
drsyam@sctimst.ac.in |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 2 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee, Sree Chitra Tirunal Institute for Medical Sciences and Technology, Thiruvananthapuram |
Approved |
| Institutional Ethics Committee, Sree Chitra Tirunal Institute for Medical Sciences and Technology, Thiruvananthapuram |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: G20||Parkinsons disease, |
|
|
Intervention / Comparator Agent
|
|
|
Inclusion Criteria
|
| Age From |
60.00 Year(s) |
| Age To |
85.00 Year(s) |
| Gender |
Both |
| Details |
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
|
|
| ExclusionCriteria |
| Details |
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 |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Gut flora differences between Parkinsons disease patients and healthy volunteers |
At the time of recruitment |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Metabolomic Profile of biological fluids (Serum, saliva, Urine) |
At the time of recruitment |
|
|
Target Sample Size
|
Total Sample Size="125"
Sample Size from India="125"
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
10/12/2019 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="3"
Months="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
NIL - None Yet |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
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) |