Impact of prebiotic (Lacto-N-neotetraose) and probiotic (B. infantis EVC001) supplementation on gut inflammation and fecal pH in young infants suffering from severe acute malnutrition: findings from a randomized controlled trial

Abstract BackgroundSevere acute malnutrition (SAM) is associated with high levels of gamma Proteobacteria chronic gut inflammation and poor gut health. In this study, we aimed to assess the effects of probiotic and/or prebiotic supplementation on gut inflammation and fecal pH in young infants with SAM.MethodsThis study was a single-blind RCT where infants aged between 2 and 6 months were randomized to receive either: probiotic (B. infantis EVC001), synbiotic (prebiotic, Lacto-N-neotetraose [LNnT] plus probiotic [B. infantis EVC001]), or placebo (Lactose) for 28 days followed by 28 days of post-supplementation follow up. Stool samples were collected at baseline and at day 10, day 28 and day 56. Fecal myeloperoxidase (MPO), as an indicator of gut inflammation and fecal pH were measured and the change in the levels of these biochemical parameters between the sample collection time points were calculated and denoted as ∆MPO and ∆pH. Kruskal-Wallis test was done to assess the effect of the supplementations on ∆MPO and ∆pH. Multivariate quantile regression analysis was performed to analyze the association of the supplements with ∆MPO and ∆pH.ResultsIn comparison to the placebo group at day 10, a significant decrease in ∆MPO was found for the probiotic group (β-coefficient: -18.44; 95% CI: -31.62 µg/ml, -52.47 µg/ml; p = 0.007) and for the synbiotic group (β-coefficient: -17.24; 95% CI: -30.94 µg/ml, -35.36 µg/ml; p = 0.015). This reduction in ∆MPO in comparison to the placebo group was sustained only in the synbiotic group at other time points. Decrease in ∆pH was observed only in the synbiotic group at day 10 and day 28, but not at day 56 in comparison to the placebo group.ConclusionOur findings demonstrate that the use of this synbiotic supplementation may result in sustained effects in reduction of gut inflammation in young infants with SAM. However, further studies are required to fully evaluate the role of this synbiotic intervention for sustained reduction in fecal pH in this study population.Trial registrationThe trial is registered at ClinicalTrials.gov (NCT0366657). Registered on 12 September, 2018 (https://clinicaltrials.gov/ct2/show/NCT03666572)