Health Condition 1: G809- Cerebral palsy, unspecified
Conditions
Interventions
Sponsors
Eligibility
Inclusion criteria
Inclusion criteria: a)children aged 2-12 years diagnosed with CP (any type, per gross motor function classification system {GMFCS} levels 1-4) and epilepsy (confirmed by EEG and clinical history). b)atleast one seizure per month in the past 3 months despite stable antiepileptic drugs therapy. c)parental consent and child assent.
Exclusion criteria
Exclusion criteria: a)use of probiotics or antibiotics within 4 weeks prior to enrollment. b)severe GI disorders. c)immunocompromised status or severe comorbidities. d)recent changes in AED regimen(within 4 weeks). e)participation in another clinical trial.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| severity and frequency of epileptic episodes in children with cerebral palsy and epilepsy.Timepoint: at baseline and after 3 months of probiotics use or end of therapy, whichever is later. | — |
Secondary
| Measure | Time frame |
|---|---|
| 1.To assess the role of probiotics in improving the quality of life in children with cerebral palsy and epilepsy. b)to evaluate the role of probiotics in changing GI symptoms in patients with CP and Epilepsy 3.to investigate the safety and tolerability of probiotics in patients with CP and Epilepsy Timepoint: at baseline and after 3 months of probiotics use or end of therapy, whichever is later. | — |
Countries
India
Contacts
Government Medical College and Hospital, Chhatrapati Sambhajinagar.