Skip to content

The role of probiotics in reducing seizure frequency in children with drug resistant epilepsy

Efficacy of probiotics on reduction of seizure frequency in Drug Resistant Epilepsy in children - Triple blinded randomized controlled trial - NIL

Status
Active, not recruiting
Phases
Phase 3Phase 4
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2026/06/112267
Enrollment
140
Registered
2026-06-09
Start date
Unknown
Completion date
Unknown
Last updated
2026-06-22

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

Conditions

Health Condition 1: G409- Epilepsy, unspecified

Interventions

Intervention1: Probiotics: Probiotics sachets for 12 weeks containing (Total-10 billion CFU) Bididobacterium breve UBBr-01 - 1 billion CFU Bifidobacterium longum UBBL-64 - 1 billion CFU Lactobacil

Sponsors

Jawaharlal Institute of Postgraduate Medical Education and Research(JIPMER)
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: Children with drug resistant epilepsy(based on ILAE definition) aged 1 years to 18 years.

Exclusion criteria

Exclusion criteria: 1.Breastfeeding children. 2.Immunocompromised children. 3.DRE children on a confounding diet(ketogenic diet). 4.Chronic gastrointestinal diseases like IBD,IBS,Celiac disease . 5.Severe Acute malnutrition . 6.Recent or current probiotic/synbiotic usage (within 4 weeks of time of recruitment). 7.Acute infection at the time of recruitment. 8.Recently added anti epileptic medication(3 months). 9.Recent use of antibiotics (within 4 weeks ). Known hypersensitivity to Probiotics. 10.Pseudo Drug resistant Epilepsy.

Design outcomes

Primary

MeasureTime frame
To study the Efficacy of Probiotics in reducing the seizure frequency in Drug Resistant Epilepsy and to assess the responder rate from the baseline i.e more than or equal 50 percentage in seizure reduction. Timepoint: 16 weeks

Secondary

MeasureTime frame
To assess the reduction in levels of IL6 from the baseline. To evaluate the adverse effects associated with Probiotic usage in children. Timepoint: 12 weeks

Countries

India

Contacts

Public ContactDr Tamil Selvan

JIPMER, Puducherry

drselvantg@yahoo.com9916485716

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Jun 29, 2026