gms | German Medical Science

Does administration of live, multi-strain pro/synbiotics with a high number of lactobacilli and bifidobacteria reduce systemic inflammation, improve gut health and growth and in infants in western Kenya?

Methods: Newborns exposed to poor sanitation and hygiene, at risk of growth faltering and delivered at the Homa Bay County Teaching and Referral Hospital, western Kenya, were recruited to an open-label, randomized, 4-arm trial. Infants aged 1–3 days were randomly allocated in a 1:1:1:1 ratio stratified by HIV exposure, to receive either Lab4b probiotic, Lab4b synbiotic, Labinic synbiotic, or no supplement daily for ten days and then weekly until age six months. Biomarkers of systemic inflammation, gut health and growth were measured in blood and stool samples and anthropometry measured at 6 weeks, and 3 and 6 months. Serious adverse events and mortality were monitored continuously.

Results: Six hundred newborns were enrolled between October 2020 and January 2022. Baseline demographic, clinical, socio-economic and hygiene/sanitation parameters were similar in the four study arms. 18% of infants were HIV exposed. Among the controls, chronic systemic inflammation (plasma α1-acid glycoprotein [AGP] concentration) increased progressively at 3 and 6 months but this was almost completely abrogated in each of the intervention arms (Figure [Fig. 1]). At 6 months, plasma AGP was raised (>1 g/L) in 56/134 (41.8%) infants in the control arm but <1.5% infants in each of the intervention arms (P<0.001). Plasma C-reactive protein was increased in the controls compared to each of the intervention arms at 3 months (P<0.001). Regarding gut health, the following were increased in the controls compared to each of the intervention arms: gut inflammation (faecal myeloperoxidase concentration; P<0.001 at 3 and 6 months); intestinal permeability (faecal α1-antitrypsin; P<0.001 at 6 months) and mucosal damage (plasma intestinal fatty acid binding protein; P<0.001 at 6 months). Concentrations of growth hormones (plasma insulin-like growth factor-1 and IGF binding protein 3) were significantly lower in controls at 6 months but length-for-age, weight-for-length and other anthropometric indices were similar in the study arms. 13 (2.2%) children have died to date; mortality and serious adverse events have been similar in the study arms.

Discussion: Administration of multi-strain pro/synbiotics to young infants reduces systemic inflammation, likely as a result of improved gut health, and is not associated with adverse effects. Further research should evaluate the possible short and longer-term health benefits of reduced early-life inflammation, assess growth when used outside of the context of a clinical trial with less interaction with research and health staff and also explore underlying mechanisms to optimise the intervention.