Objective Iron-containing micronutrient powders (MNPs) reduce anaemia in African infants, but the current high iron dose (12.5 mg/day) may decrease gut Bifidobacteriaceae and Lactobacillaceae , and increase enteropathogens, diarrhoea and respiratory tract infections (RTIs). We evaluated the efficacy and safety of a new MNP formula with prebiotic galacto-oligosaccharides (GOS) combined with a low dose (5 mg/day) of highly bioavailable iron. Design In a 4-month, controlled, double-blind trial, we randomised Kenyan infants aged 6.5–9.5 months (n=155) to receive daily (1) a MNP without iron (control); (2) the identical MNP but with 5 mg iron (2.5 mg as sodium iron ethylenediaminetetraacetate and 2.5 mg as ferrous fumarate) (Fe group); or (3) the identical MNP as the Fe group but with 7.5 g GOS (FeGOS group). Results Anaemia decreased by ≈50% in the Fe and FeGOS groups (p<0.001). Compared with the control or FeGOS group, in the Fe group there were (1) lower abundances of Bifidobacterium and Lactobacillus and higher abundances of Clostridiales (p<0.01); (2) higher abundances of virulence and toxin genes (VTGs) of pathogens (p<0.01); (3) higher plasma intestinal fatty acid-binding protein (a biomarker of enterocyte damage) (p<0.05); and (4) a higher incidence of treated RTIs (p<0.05). In contrast, there were no significant differences in these variables comparing the control and FeGOS groups, with the exception that the abundance of VTGs of all pathogens was significantly lower in the FeGOS group compared with the control and Fe groups (p<0.01). Conclusion A MNP containing a low dose of highly bioavailable iron reduces anaemia, and the addition of GOS mitigates most of the adverse effects of iron on the gut microbiome and morbidity in African infants. Trial registration number NCT02118402.

中文翻译：

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益生元低聚半乳糖减轻了铁强化对肠道微生物组的不利影响：肯尼亚婴儿的一项随机对照研究

目的含铁微量营养素粉（MNP）可以减少非洲婴儿的贫血，但是目前的高铁剂量（12.5 mg /天）可以减少肠道双歧杆菌科和乳杆菌科，并增加肠病原，腹泻和呼吸道感染（RTIs）。我们评估了将益生元低聚半乳糖（GOS）与低剂量（5 mg /天）的高生物利用度铁结合使用的新型MNP配方的功效和安全性。设计在一项为期4个月的对照双盲试验中，我们将6.5-9.5个月（n = 155）的肯尼亚婴儿随机分为两组，每天接受（1）不含铁的MNP（对照）。（2）相同的MNP，但含铁5 mg（乙二胺四乙酸钠铁为2.5 mg，富马酸亚铁为2.5 mg）（Fe组）；或（3）与Fe组相同的MNP，但具有7.5 g GOS（FeGOS组）。结果Fe和FeGOS组的贫血减少了约50％（p <0.001）。与对照组或FeGOS组相比，在Fe组中：（1）双歧杆菌和乳杆菌的丰度较低，梭菌的丰度较高（p <0.01）；（2）病原体的毒力和毒素基因（VTG）含量更高（p <0.01）；（3）血浆中肠道脂肪酸结合蛋白较高（肠细胞损伤的生物标志物）（p <0.05）；（4）治疗的RTIs发生率更高（p <0.05）。相反，与对照组和FeGOS组相比，这些变量没有显着差异，除了FeGOS组的所有病原体的VTG丰度明显低于对照组和Fe组（p <0.01）。结论含有低剂量高生物利用度铁的MNP可以减少贫血，加入GOS可减轻铁对非洲婴儿肠道微生物组和发病率的大部分不利影响。试用注册号NCT02118402。