Double Blind Randomised control trail to study the role of two species Probiotics in prevention of Antibiotics Associated Diarrhoea(AAD)

Authors
Category Primary study
Registry of TrialsClinical Trials Registry - India
Year 2023
INTERVENTION: Intervention1: ORAL PROBIOTICS: GROUP A WILL RECEIVE MIXTURE OF LACTOBACILLUS RAHAMNOSUS GG AND SACCHAROMYCES BOULARDII ONE SACHET TWICE DAILY for duration of antibioticss (5 to 10days) Control Intervention1: ORAL PLACEBO: GROUP B WILL RECEIVE ORAL PLACEBO HAVING SIMILAR TASTE AND SMELL ONE SACHET TWICE DAILY Control Intervention2: ORAL PLACEBO: GROUP B WILL RECEIVE MIXTURE OF PLACEBO ONE SACHET TWICE DAILY for duration of antibioticss (5 to 10days) CONDITION: Health Condition 1: K929‐ Disease of digestive system, unspecified PRIMARY OUTCOME: To compare the proportion of children developing antibiotic associated diarrhoea (AAD) in those supplemented with two species probiotic and with placebo.Timepoint: 1st week after completion of Antibiotics. ; 2nd week after completion of antibiotics SECONDARY OUTCOME: To assess mean duration of diarrhoea ; Side effects of Probiotics ; Timepoint: 2 WEEKS INCLUSION CRITERIA: Children from 1 to 18yrs. Hemodynamically stable. Antibiotics adminstration planned for 5 to 10days. Ability to start probiotics within 24hrs after start of antibiotcs. Oral & parenteral antibiotics
Epistemonikos ID: 8d9d046c69ffc5fc7936e081ae56eccacc952b98
First added on: Feb 20, 2024