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A RANDOMIZED CONTROLLED TRIAL TO STUDY THE EFFECT OF PROBIOTICS ON CHANGE IN LEVELS OF INFLAMMATORY MEDIATORS IN CRITICALLY ILL CHILDREN WITH SEVERE SEPSIS.

EVALUATION OF EFFECT OF PROBIOTICS ON CHANGE IN CYTOKINE LEVELS IN CRITICALLY ILL CHILDREN WITH SEVERE SEPSIS: A RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED TRIAL (PILOT STUDY)

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2015/04/005708
Enrollment
40
Registered
2015-04-21
Start date
Unknown
Completion date
Unknown
Last updated
2025-05-26

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

Conditions

None listed

Interventions

Intervention1: PROBIOTICS: Probiotic group will receive VSL#3® (VSL Pharmaceuticals, Inc. Tawson, MD 21204-USA) which is a high-dose, multi-strain probiotic product. Each sachet of VSL#3® contains 4
3 strains of Bifidobacterium (B. longum, B. breve, and B. infantis)
1 strain of Streptococcus (Streptococcus salivarius subsp. thermophilus)
and maltose and silicon dioxide as base. The dose will be one sachet twice a day (900 billion CFU/day) orally or through feeding tube (whichever is possible) for 7 days. Control Intervention1: PLACEB

Sponsors

POST GRADUATE INSTITUTE OF MEDICAL EDUCATION AND RESEARCH CHANDIGARH
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: 1. Any patient admitted to PICU with diagnosis of severe sepsis. 2. Age group: 3 months-12 years.

Exclusion criteria

Exclusion criteria: 1. Hospital stay of >72 hours prior to PICU admission. 2. Children who cannot tolerate enteral nutrition. 3. Known chronic illness. 4. Suspected or proven viral infection. 5. Known immunodeficiency states or malignancy. 6. Children on prior steroids/immunotherapy. 7. Children with severe acute malnutrition (as per WHO). 8. Children who received probiotic therapy in last 1 month.

Design outcomes

Primary

MeasureTime frame
Change in levels of cytokines (IL-6, IL-12, IL-17, TNF- α, IL-10, and TGF-β) in critically ill children with severe sepsis receiving probiotics and those receiving placeboTimepoint: Day 1 and day 7—

Secondary

MeasureTime frame
To compare the two groups for: â?¢SOFA score on day 1 and 7 â?¢Incidence of health care associated infection (HCAI) â?¢Length of PICU stay â?¢Survival or death Timepoint: Patients will be followed up till the discharge from PICU or death.—

Countries

India

Contacts

Public ContactARUN BANSAL

POSTGRADUATE INSTITUTE OF MEDICAL EDUCATION & RESEARCH

sureshangurana@gmail.com9855373969

Outcome results

None listed

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