Health Condition 1: G20- Parkinsons disease
Conditions
Interventions
Intervention1: Probiotic containing 5 strains of lactobacilli (L. acidophilus, L. helveticus, L. casei, L. plantarum, L. brevis), 2 strains of Bifidobacterium lactis and 1 strain of Streptococcus ther
Sponsors
Dept of Science and Technology
Eligibility
Inclusion criteria
Inclusion criteria: 1. Diagnosis of PD according to the diagnostic criteria of UK Brain Bank (Exclusion criterion for the controls) (Gelb et al., 1999) 2. The onset of motor symptoms for at least five years 3. presence of motor fluctuations (UPDRS item 39 = 1) 4. Aged between 50 and 70 years 5. Stable diet during the study 6. Signed consent to the study 7. Absence of exclusion criteria
Exclusion criteria
Exclusion criteria: 1. Clinical diagnosis of IBS at the time of screening 2. Use of antibiotics, probiotics or other drugs that affect the composition of the intestinal flora in the month prior to enrollment 3. Use of immunosuppressive drugs 4. Major systemic diseases (cancer and / or liver disease / chronic kidney disease) 5. Other Endocrine/ metabolic disorders (eg. diabetes mellitus, thyroid related) 6. Use of drugs (eg prokinetics, anticholinergics, tricyclic antidepressants, clozapine, quetiapine) that can alter gastrointestinal motility
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1. Improvement in cognitive functioning of patients with Parkinson’s by the following scales and questionnaires: Parkinson’s disease-cognitive functional rating scale (PD-CFRS), Parkinson’s disease-cognitive rating scale (PD-CRS), and task based methods such as N-back task, go-no go association task (GNAT), Executive & attention tests and recording the prefrontal cortical activity during these cognitive tasks. 2. Improvement in Neuroimaging done by functional near IR spectroscopyTimepoint: 3 months | — |
Secondary
| Measure | Time frame |
|---|---|
| Change in the level of brain derived neurotrophic factor (BDNF), oxidative, stress & inflammatory markers in bloodTimepoint: 3 months;Changes in fecal microbiota and the metabolome, and in urinary metabolic profile Timepoint: 3 months;Changes in gastrointestinal symptoms evaluated with Bristol Scale and IBS QuestionnaireTimepoint: 3 months;Improvement in motor functioning by measuring movement related cortex potential (MRCP) with resolution for deep-nuclei, abnormal movement by NeuropackTimepoint: 3 months;Improvement in the quality of life, as assessed by the scale WHO QoL: BREFTimepoint: 3 months;Improvement of non-motor symptoms, as assessed by the scale, NMSSTimepoint: 3 months;Reduction in time spent in off motor during 24 hours, as assessed by clinical diariesTimepoint: 3 months;Reduction in time spent with troublesome dyskinesias during 24 hours, as assessed by clinical diariesTimepoint: 3 months | — |
Countries
India
Contacts
Public ContactKanwal Preet Kochhar
All India Institute of Medical Sciences
Outcome results
None listed