Lactobacillus reuteri DSM for the management of infantile colic in breastfed infants A randomized, double-blind, placebo-controlled trial

Introduction

Definition of infantile colic CRITERIA < 4 months of age Paroxysms > 3 hours / day > 3 days / week Min. 1 week No FTT

A number of therapies for infantile colic Sucrose ? Increased carrying, music, vibration or massage, & spinal manipulation ? Herbal teas ? Soy formula ? Fiber-enriched formulas ? Lactose- reduced formula ? Hydrolyzed formulas ? Probiotics ?!

Research in using probiotics in breastfed infants with infantile colic Savino F, et al. Pediatrics  Lactobacillus reuteri (American Type Culture Collection Strain 55730) vs simethicone Savino F, et al. Pediatrics  Lactobacillus reuteri DSM vs placebo Szajewska H, et al. Pediatrics  Lactobacillus reuteri DSM vs placebo

Analysis of the most recent study about probiotics as therapy for infantile colic in breastfed infants Szajewska H, et al. Pediatrics  Lactobacillus reuteri DSM vs placebo

Aim Do exclusively or predominantly breastfed infants with infantile colic benefit from treatment with L reuteri DSM compared with placebo ? Probiotic productPlacebo product

Population Eligible (n=174) Probiotic group (n=42) Analyzed (n=40) Placebo group (n=40) Analyzed (n=40) Randomized (n=82) 39 declined & 53 excluded Exclusion - Illness - GI disorders - Use of AB / probiotica Independent allocation 1 lost to follow-up & 1 discontinued Inclusion - < 5 m - Breastfed - Criteria of infantile colic

Szajewska H, et al. Pediatrics

Intervention 5 drops / day during 21 days Visiting same physician at day 7,14, 21 & 28 Recording in a diary till day 28 All participants & investigators were blinded

Outcome measures Primary Treatment success Duration of crying Secondary Reduction in daily average crying time Persistence of infantile colic Parental perceptions Family quality of life Adverse effects None in both groups

Szajewska H, et al. Pediatrics Treatment success Duration of crying (min/d) D7 D14 D21 D28 D0 D7 D14 D21 D28

Szajewska H, et al. Pediatrics Reduction in daily average crying time D21 D28 BL D7 D21 D28 D7 D21 D28 Parental perception of severity (0- no pain; 10-severe pain) Family QoL (0-no effect; 10- very good effect)

Conclusion L reuteri DSM Placebo Superior in breastfed infants Confirmation of previous study Exact mechanisms ?

Discussion

Strengths and limitations Effect size Criteria for infantile colic Sample size Allocation Proper blinding Family history of allergy No objectivation of crying Compliance ? Not fully exclusive breastfeeding

Significant outcome measures Confirmation of previous study Generally good safety profile Some limitation in both studies Worth to try out L reuteri DSM in breastfed infants with infantile colic, BUT at the same time using caution with interpreting the findings Now… What’s next in medical practice?

Any questions ?