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

• Register: CTRI
• Last refreshed on: 24 November 2021
• Main ID: CTRI/2015/04/005708
• Date of registration: 21-04-2015
• Prospective Registration: No
• Primary sponsor: POST GRADUATE INSTITUTE OF MEDICAL EDUCATION AND RESEARCH CHANDIGARH
• Public title: A RANDOMIZED CONTROLLED TRIAL TO STUDY THE EFFECT OF PROBIOTICS ON CHANGE IN LEVELS OF INFLAMMATORY MEDIATORS IN CRITICALLY ILL CHILDREN WITH SEVERE SEPSIS.
• Scientific title: 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)
• Date of first enrolment: 01-11-2014
• Target sample size: 40
• Recruitment status: Open to Recruitment
• URL: http://www.ctri.nic.in/Clinicaltrials/pmaindet2.php?trialid=10363
• Study type: Interventional
• Study design: Randomized, Parallel Group, Placebo Controlled Trial; Method of generating randomization sequence:Computer generated randomization Method of allocation concealment:Sequentially numbered, sealed, opaque envelopes Blinding and masking:Participant, Investigator and Outcome Assessor Blinded
• Phase: N/A

Countries of recruitment

India

Contacts

• Name: SURESH KUMAR
• Affiliation: POSTGRADUATE INSTITUTE OF MEDICAL EDUCATION & RESEARCH

• Name: ARUN BANSAL
• Affiliation: POSTGRADUATE INSTITUTE OF MEDICAL EDUCATION & RESEARCH

Key inclusion & exclusion criteria

Inclusion criteria: 1. Any patient admitted to PICU with diagnosis of severe sepsis.

2. Age group: 3 months-12 years.


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.



Age minimum:
Age maximum:
Gender:

Health Condition(s) or Problem(s) studied

Health Condition 1: null- CRITICALLY ILL CHILDREN WITH SEVERE SEPSIS

Intervention(s)

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 450 billion viable lyophilized bacteria consisting of 4 strains of Lactobacillus (� L. paracasei, L. plantarum, L. acidophilus, and L. delbrueckii subsp. bulgaricus); 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: PLACEBO: Placebo group will receive only maltose and silicon dioxide.

Primary Outcome(s)

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 Outcome(s)

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.

Secondary ID(s)

NIL

Source(s) of Monetary Support

POST GRADUATE INSTITUTE OF MEDICAL EDUCATION AND RESEARCH CHANDIGARH (PGIMER), CHANDIGARH, INDIA

Ethics review

Status: Approved
Approval date: 24/09/2014
Contact:

Institute ethics committee (intramural), PGIMER, Chandigarh