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How probiotics affect gut health in unconscious children on ventilators (not caused by injury)

Effects of Probiotics on Gut Microbiome in Children with Non Traumatic Coma Requiring Mechanical Ventilation - A Randomized Control Study - NIL

Status
Active, not recruiting
Phases
Phase 3
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2025/06/089370
Enrollment
50
Registered
2025-06-23
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: G053- Encephalitis and encephalomyelitisin diseases classified elsewhere

Interventions

Intervention1: Probiotic therapy: Probiotic includes S. thermophilus, L.acidophilus, L. plantarum, L. paracasei, L. Helveticus, L. brevis, B. lactis ( 2 strains ) Weight based: 5 - 10 KG - 10 - 20 Bil

Sponsors

Special research grant for MDDM students of Department of Pediatrics and microbiology
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: All premorbidly well children between age group of more than 28 days to less than 13 years admitted in PICU with non traumatic coma of any etiology requiring mechanical ventilation.

Exclusion criteria

Exclusion criteria: Known chronic illness, Immunodeficiency states, Malignancy, Prior steroids or immunotherapy, severe acute malnutrition, Probiotic therapy in last 1 month , Not able to start enteral nutrition for more than 48 hours of PICU admission, Prior antibiotics more than 48 hrs and parents who refused consent.

Design outcomes

Primary

MeasureTime frame
Profile of gut microbiome in both groupsTimepoint: At baseline and 7 days of probiotic and placebo therapy

Secondary

MeasureTime frame
Profile of cytokines in probiotics & placebo groupTimepoint: Baseline, day 3 & day 7 of enrollment;Oxygenation indices among both groupsTimepoint: Baseline & day 7;Ventilation free daysTimepoint: day 28;Health care associated infections & antibiotic usageTimepoint: at discharge;28 day mortalityTimepoint: Day 28;GOSE scale among both groupsTimepoint: at discharge & 3 months;POPC, PCPC, HUI 2Timepoint: at 3 months

Countries

India

Contacts

Public ContactArun Bansal

Post Graduate Institute Of Medical Education and Research

drarunbansal@gmail.com9815455002

Outcome results

None listed

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