Pediatric Research Center, Children's Hospital, University of Helsinki and Helsinki University Hospital, Helsinki, Finland; Research Program for Clinical and Molecular Metabolism, Faculty of Medicine, University of Helsinki, Helsinki, Finland.
Pediatric Research Center, Children's Hospital, University of Helsinki and Helsinki University Hospital, Helsinki, Finland; Center for Child Health Research, University of Tampere and Tampere University Hospital, Tampere, Finland.
J Pediatr. 2021 Nov;238:305-311.e3. doi: 10.1016/j.jpeds.2021.07.042. Epub 2021 Jul 20.
To assess whether weaning to an extensively hydrolyzed formula (EHF) decreases gut permeability and/or markers of intestinal inflammation in infants with HLA-conferred diabetes susceptibility, when compared with conventional formula.
By analyzing 1468 expecting biological parent pairs for HLA-conferred susceptibility for type 1 diabetes, 465 couples (32 %) potentially eligible for the study were identified. After further parental consent, 332 babies to be born were randomized at 35th gestational week. HLA genotyping was performed at birth in 309 infants. Out of 87 eligible children, 73 infants participated in the intervention study: 33 in the EHF group and 40 in the control group. Clinical visits took place at 3, 6, 9, and 12 months of age. The infants were provided either EHF or conventional formula whenever breastfeeding was not available or additional feeding was required over the first 9 months of life. The main outcome was the lactulose to mannitol ratio (L/M ratio) at 9 months. The secondary outcomes were L/M ratio at 3, 6, and 12 months of age, and fecal calprotectin and human beta-defensin 2 (HBD-2) levels at each visit.
Compared with controls, the median L/M ratio was lower in the EHF group at 9 months (.006 vs .028; P = .005). Otherwise, the levels of intestinal permeability, fecal calprotectin, and HBD-2 were comparable between the two groups, although slight differences in the age-related dynamics of these markers were observed.
It is possible to decrease intestinal permeability in infancy through weaning to an extensively hydrolyzed formula. This may reduce the early exposure to dietary antigens.
Clinicaltrials.gov: NCT01735123.
评估与常规配方相比，在具有 HLA 赋予的糖尿病易感性的婴儿中，逐渐转为深度水解配方（EHF）是否会降低肠道通透性和/或肠道炎症标志物。
通过分析 1468 对具有 HLA 赋予的 1 型糖尿病易感性的预期生物父母对，确定了 465 对（32%）有资格参加研究的夫妇。在获得进一步的父母同意后，在 35 孕周时对 332 名即将出生的婴儿进行随机分组。在 309 名婴儿中进行了 HLA 基因分型。在 87 名合格的儿童中，有 73 名婴儿参加了干预研究：EHF 组 33 名，对照组 40 名。临床访视在 3、6、9 和 12 个月龄时进行。当母乳喂养不可用时，或者在生命的前 9 个月需要额外喂养时，婴儿会提供 EHF 或常规配方。主要结局是 9 个月时乳果糖与甘露醇的比值（L/M 比值）。次要结局是 3、6 和 12 个月时的 L/M 比值，以及每次访视时的粪便钙卫蛋白和人β防御素 2（HBD-2）水平。
与对照组相比，EHF 组在 9 个月时的中位数 L/M 比值较低（0.006 比 0.028；P=0.005）。否则，两组之间的肠道通透性、粪便钙卫蛋白和 HBD-2 水平相当，尽管这些标志物的年龄相关动态存在细微差异。
通过逐渐转为深度水解配方，可以降低婴儿期的肠道通透性。这可能会减少早期接触饮食抗原。
Clinicaltrials.gov：NCT01735123。
