Béghin Laurent, Tims Sebastian, Roelofs Mieke, Rougé Carole, Oozeer Raish, Rakza Thameur, Chirico Gaetano, Roeselers Guus, Knol Jan, Rozé Jean Christophe, Turck Dominique
Univ. Lille, CHU Lille, Clinical Investigation Center, CIC-1403-Inserm-CHU and U1286 - INFINITE - Institute for Translational Research in Inflammation, F-59000, Lille, France.
Danone Nutricia Research, Utrecht, the Netherlands.
Clin Nutr. 2021 Mar;40(3):778-787. doi: 10.1016/j.clnu.2020.07.024. Epub 2020 Jul 23.
BACKGROUND & AIMS: Microbiome-modulators can help positively steer early-life microbiota development but their effects on microbiome functionality and associated safety and tolerance need to be demonstrated. We investigated the microbiome impact of a new combination of bioactive compounds, produced by the food-grade microorganisms Bifidobacterium breve C50 and Streptococcus thermophilus ST065 during a fermentation process, and prebiotics in an infant formula. Tolerance and safety were also assessed.
An exploratory prospective, randomized, double-blind, controlled, multi-centre study was designed to investigate the effect of bioactive compounds and prebiotics (short-chain galacto-oligosaccharides (scGOS)/long-chain fructo-oligosaccharides (lcFOS) 9:1). Experimental formulas containing these bioactive compounds and prebiotics (FERM/scGOS/lcFOS), prebiotics (scGOS/lcFOS), or bioactive compounds (FERM), were compared to a standard cow's milk-based control formula (Control). Exclusively breastfed infants were included as a reference arm since exclusive breastfeeding is considered as the optimal feeding for infants. The study lasted six months and included visits to health care professionals at baseline, two, four and six months of age. Stool SIgA concentration was the primary study outcome parameter.
There were 280 infants randomized over the experimental arms and 70 infants entered the breastfed-reference arm. Demographics were balanced, growth and tolerance parameters were according to expectation and adverse events were limited. At four months of age the median SIgA concentration in the FERM/scGOS/lcFOS group was significantly higher compared to the Control group (p = 0.03) and was more similar to the concentrations found in the breastfed-reference group. Bifidobacterium increased over time in all groups. The FERM/scGOS/lcFOS combination resulted in a microbiota composition and metabolic activity closer to the breastfed infants' microbiome.
The FERM/scGOS/lcFOS combination showed a significant positive effect on SIgA levels. All formulas tested were associated with normal growth and were well-tolerated. Additionally, at four months of age the FERM/scGOS/lcFOS formula brought the microbiome composition and metabolic activity closer towards that of breastfed infants.
Registration number NTR2726 (Netherlands Trial Register; www.trialregister.nl/).
微生物群调节剂有助于积极引导生命早期微生物群的发育，但其对微生物群功能以及相关安全性和耐受性的影响仍需证实。我们研究了由食品级微生物短双歧杆菌C50和嗜热链球菌ST065在发酵过程中产生的生物活性化合物新组合以及婴儿配方奶粉中的益生元对微生物群的影响。同时还评估了耐受性和安全性。
设计了一项探索性前瞻性、随机、双盲、对照、多中心研究，以调查生物活性化合物和益生元（短链低聚半乳糖（scGOS）/长链低聚果糖（lcFOS）9:1）的作用。将含有这些生物活性化合物和益生元的实验配方奶粉（FERM/scGOS/lcFOS）、益生元（scGOS/lcFOS）或生物活性化合物（FERM）与标准的基于牛乳的对照配方奶粉（对照）进行比较。由于纯母乳喂养被认为是婴儿的最佳喂养方式，因此将纯母乳喂养的婴儿纳入作为参考组。该研究持续六个月，包括在基线、2个月、4个月和6个月龄时拜访医疗保健专业人员。粪便分泌型免疫球蛋白A（SIgA）浓度是主要的研究结果参数。
共有280名婴儿被随机分配到各实验组，70名婴儿进入纯母乳喂养参考组。人口统计学特征均衡，生长和耐受性参数符合预期，不良事件有限。在4个月龄时，FERM/scGOS/lcFOS组的SIgA浓度中位数显著高于对照组（p = 0.03），且与纯母乳喂养参考组中的浓度更为相似。所有组中的双歧杆菌数量均随时间增加。FERM/scGOS/lcFOS组合使微生物群组成和代谢活性更接近纯母乳喂养婴儿的微生物群。
FERM/scGOS/lcFOS组合对SIgA水平显示出显著的积极影响。所有测试的配方奶粉都与正常生长相关且耐受性良好。此外，在4个月龄时，FERM/scGOS/lcFOS配方奶粉使微生物群组成和代谢活性更接近纯母乳喂养婴儿。
注册号NTR2726（荷兰试验注册；www.trialregister.nl/）
