Probiotic supplementation and sepsis

Phase 3

• Conditions: Severe sepsis.; Severe sepsis; R65.2

• Registration Number: IRCT20170202032367N10
• Lead Sponsor: Tehran University of Medical Sciences

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 21 August 2023

Recruitment & Eligibility

• Status: Pending
• Sex: All
• Target Recruitment: 44

Inclusion Criteria

Aged 1-12 years old
Diagnosis of severe sepsis according to pediatric sepsis consensus conference 2005 criteria in children admitted to PIC

Exclusion Criteria

PICU admission more than 72 hours
Ileus, overt gastrointestinal bleeding, anatomic obstruction of the gastrointestinal tract (eg, volvulus, intestinal atresia), recent esophageal or gastrointestinal surgery
Gastrointestinal diseases such as celiac disease, inflammatory bowel disease (IBD), short bowel syndrome (SBS), irritable bowel syndrome (IBS)
Use of feeding routes leading to jejunum such as jejunostomy
Probiotic use one month before entering the study
Use of steroids and other immunosuppressive drugs
Suffering from immunosuppressive diseases such as malignant tumors, acquired immunodeficiency syndrome, etc.
Severe acute malnutrition (According to the World Health Organization: Z-Score weight for height/length and BMI less than -3 SD average child growth standards WHO

Study & Design

• Study Type: interventional
• Study Design: Not specified