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Role of friendly gut bacteria in Children with Cerebral Palsy and seizure disorder

Role of Probiotics as an Adjuvant in Children with Cerebral Palsy and Epilepsy-A Double Blind Randomized Placebo-Controlled Study. - nil

Status
Active, not recruiting
Phases
Phase 3Phase 4
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2025/07/090407
Enrollment
60
Registered
2025-07-07
Start date
Unknown
Completion date
Unknown
Last updated
2025-07-21

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: G809- Cerebral palsy, unspecified

Interventions

Intervention1: probiotics.: probiotic group will receive multistrain probiotic supplement containing lactobacillus rhamnosus, bifidobacterium longum (total 10^9 CFU/day),administered orally once daily

Sponsors

simra khan
Lead Sponsor

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

MeasureTime 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

MeasureTime 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

Public ContactSimra khan

Government Medical College and Hospital, Chhatrapati Sambhajinagar.

smita.mundada@gmail.com9224287215

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026