Aim To evaluate the influence of maternal supplementation with VSL#3 on digestive events in newborns and cytokines levels in colostrum and mature breast milk.
Methods This pilot double-blind, randomised, placebo-controlled clinical trial (clinicaltrials.gov: NCT01367470) enrolled four weeks before expected delivery healthy pregnant women that received daily oral VSL#3 (PTM) or placebo (CM) supplementation until four weeks after delivery. In milk samples we measured IL10 and TGFb (with commercial ELISA kits) at birth (T0) and after 30 (T30) days. Stool frequency and consistency (Bristol stool scale), regurgitation/vomiting, colics (Rome III criteria) in newborns were recorded in a weekly diary.
Two-way ANOVA for repeated measures, Chi-square test and RR: evaluation of time effect and link between probiotic supplementation and colics/ regurgitation.
Results 67 mothers/term newborns pairs were enrolled. In 44 milk samples we measured TGFb and IL10 with a significant increase in TGFb from T0 to T30 in PTM and a reduction in CM (interaction effect: F = 10.314 p = 0.005). IL10 was high at T0 and decreased in both groups at T30 (time effect: F = 25.808 p < 0.001). We found an higher frequency of colics and regurgitation in CM with respect to PTM newborns (colics: c2 = 7.2 p = 0.007; RR = 4; regurgitations:c2 = 6.944 p = 0.008; RR = 2.43). A TGFb modulation of muscarinic receptor involved in controls of intestinal motility could be hypotized. Regarding colics, VSL#3 could be involved in pain perception.
Conclusions VSL#3 supplementation to mothers during pregnancy and breast feeding may be a powerful immune modulator in terms of TGFb in breast milk, and can influence intestinal motility and pain perception in newborns.