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Role of gut microbiome in epilepsy patients

Modulation of gut microbiota in drug resistant epilepsy: A randomized controlled trial of high potency multistrain probiotic intervention - MOMENT

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2023/05/052680
Enrollment
60
Registered
2023-05-16
Start date
Unknown
Completion date
Unknown
Last updated
2023-12-19

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

Conditions

Health Condition 1: G403- Generalized idiopathic epilepsy and epileptic syndromes

Interventions

Intervention1: Probiotic: Multi strain probiotic preparation for 16 weeks Control Intervention1: Placebo: Matching Placebo for 16 weeks

Sponsors

PGIMER Chandigarh
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: Patients with DRE Age 18 years and above At least one seizure reported per month Currently receiving AEDs Provide Informed Consent

Exclusion criteria

Exclusion criteria: Time of onset of epilepsy treatment Non-epileptic seizures, Status epilepticus in the last 12 months, Changes in the AED type or dose in the last 30 days Active alcohol or substance overuse, Pregnancy and/or breastfeeding, Treatment with probiotics in the 30 days before Chronic gastrointestinal problems, hepatic or renal insufficiency, lactose intolerance, coeliac disease, immunodepression, long-term antibiotic use, a serious psychiatric condition, participating in any other epilepsy-related study Patients with poor compliance to AEDs

Design outcomes

Primary

MeasureTime frame
Reduction in seizure frequency Timepoint: 16 weeks

Secondary

MeasureTime frame
Gut microbiota analysis QOL assessment Safety assessmentsTimepoint: 16 weeks

Countries

India

Contacts

Public ContactAshish Kakkar

PGIMER

kakkar.ashish@pgimer.edu.in072-2755297

Outcome results

None listed

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