The Effect of Enteral Administration of Synbiotics Upon Infection Rates in Major Burns

Authors
Category Primary study
Registry of TrialsISRCTN registry
Year 2006
INTERVENTION: Two equal randomised groups, investigational medicinal product (IMP) group will be given a synbiotic cocktail comprising 10^11 of each of 4 probiotic strains and 4 prebiotics. The control group will be given only the 4 prebiotics. The IMP and control will be identically packaged and will be administered twice daily throughout the inpatient admission by either oral or gastroenteral administration. Added 01/06/10: trial stopped in 2006 (objectives no longer viable). CONDITION: Major burn injury ; Injury, Occupational Diseases, Poisoning ; Burn injury PRIMARY OUTCOME: 1. Infection rates (pre‐defined definitions); 2. Antibiotic requirements; 3. Changes in the microbiological composition of faeces SECONDARY OUTCOME: 1. Mortality rate; 2. Nutritional assessment; 3. Insulin requirements; 4. Assessment of gastrointestinal (GI) function; 5. GI side effects; 6. Fluid requirements; 7. Haematologic and biochemical trends; 8. Acute physiology scores; 9. Healing times; 10. Burn depth progression rates; 11. Length of intensive care unit (ICU) and hospital stay; 12. Mobilisation times; 13. Activities of daily living independence times; 14. Post‐burns scarring assessment; 15. Cost analysis INCLUSION CRITERIA: Adults (=16 years) with =15% total body surface area (TBSA) burn Children (<16 years) with =10% TBSA burn
Epistemonikos ID: d1ee86617d0dd48e4ccce8b45ad3f30d437c55d2
First added on: Aug 21, 2024