Journal Club Manjula Velayudhan CF Gastroenterology Sheffield Synbiotic in the management of infantile colic: A randomised controlled trial.

Background Infantile colic affects up to 30 % of infants Crying in infancy is multifactorial Altering gut microbiota helps in reducing crying time

Methods Combination of probiotic and prebiotic – synbiotic Prebiotic is fructooligosaccharide Combination of 7 probiotic strains given as a single sachet Compared with placebo Primary outcome- symptom resolution(50% reduction in crying time)

Methods Community based paediatric referrals Infants aged 2 weeks to 4 months Healthy breast fed infants included in the study Colic diagnosed by Wessel’s criteria Exclusion –failure to thrive,syndromes, organic causes Computer generated randomisation was undertaken

Methods Infants randomised to receive either synbiotic sachet Or placebo Both were dispensed by same hospital pharmacist Concealed from investigator/patient group Parents advised to give synbiotic or placebo mixed with breast milk daily for 30 days

Methods Parents asked to keep record of daily crying times, stool consistency, frequency Present for evaluation on day 7 and 28 Statistical analysis performed using SPSS

Results 50 colicky infants enrolled on to the study 45 completed the study 25 treated with synbiotic and 20 treated with placebo No adverse effects related to either treatment were seen

Results All baseline characteristics like gestational age,birthweight, history of atopy,birth order and type of delivery were comparable to both groups Primary outcome measure-50% reduction

Results Secondary outcome measure-symptom resolution. Weight gain- not statistically significant

Results

Critical Appraisal Did the study ask a focused question Was it a properly conducted randomised controlled trial Small sample size both for synbiotic and placebo group randomised blinded

Appraisal Were participants allocated groups appropriately? How was randomisation done? If the allocated groups had their characteristics compared? Any confounding factors that might interfere with outcomes?

Apparaisal How effective was blinding? Were participants, research personnel,blinded? Observer bias reduced? Were all the participants accounted for at the end of the study?

Appraisal Were all participants followed up and data collected the same way! Did the study have the minimum number to offset the play of chance What are the main results and how are they presented? How precise are these results? Are they useful to us? Reproducible locally?

Discussion Larger RCT with larger placebo group Objective outcome measures

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