The Institute of Reproductive and Child Health/Ministry of Health Key Laboratory of Reproductive Health, Department of Epidemiology and Biostatistics, School of Public Health, Peking University Health Science Center, Beijing 100191, China.
Nestlé Product Technology Center-Nutrition, 1800 Vevey, Switzerland.
Nutrients. 2021 Sep 25;13(10):3371. doi: 10.3390/nu13103371.
Partially hydrolyzed formula (pHF) containing low lactose and probiotics may benefit the gastrointestinal health of infants. We aimed to assess the effects of pHF on mild gastrointestinal disorders (MGDs) of infants. In this single-armed trial, 80 full-term infants with MGDs were enrolled and fed a pHF for 14 consecutive days. The primary outcome resulted from the scores of gastrointestinal symptoms reported by parents using a validated Infant Gastrointestinal Symptom Questionnaire (IGSQ) at Day 0 (baseline), Day 7, and Day 14. The total IGSQ scores ranged from 13 to 65. Higher scores indicated worse gastrointestinal symptoms. The IGSQ scores (mean ± SD) decreased from Day 0 (36.0 ± 5.7) to Day 7 (28.7 ± 7.4) and Day 14 (26.5 ± 8.1 ( < 0.001), with corresponding digestive distress prevalence (IGSQ score > 30) decreasing from 87.5% to 35.0% and 28.8% ( < 0.001). In the first three days, vomiting and flatulence scores decreased at Day 1 versus Day 0, and the crying score decreased at Day 2, but no significant changes were observed for fussy and stool characteristics. All growth parameters increased and no parents reported adverse events. In conclusion, feeding with a pHF containing low lactose and probiotics may comfort infants with MGDs, and the comforting effect likely manifests early in the first three days of the feeding interventions. Trial registration: ClinicalTrials.gov NCT04112056.
部分水解配方（pHF）含有低乳糖和益生菌，可能有益于婴儿的胃肠道健康。我们旨在评估 pHF 对婴儿轻度胃肠道疾病（MGD）的影响。在这项单臂试验中，招募了 80 名患有 MGD 的足月婴儿，并连续 14 天喂食 pHF。主要结局是父母使用经过验证的婴儿胃肠道症状问卷（IGSQ）在第 0 天（基线）、第 7 天和第 14 天报告的胃肠道症状评分。IGSQ 总评分范围为 13 至 65。分数越高表示胃肠道症状越差。IGSQ 评分（均值 ± 标准差）从第 0 天（36.0 ± 5.7）降至第 7 天（28.7 ± 7.4）和第 14 天（26.5 ± 8.1）（<0.001），相应的消化不适患病率（IGSQ 评分>30）从 87.5%降至 35.0%和 28.8%（<0.001）。在头三天，与第 0 天相比，第 1 天呕吐和腹胀评分降低，第 2 天哭闹评分降低，但挑剔和粪便特征无明显变化。所有生长参数均增加，且无父母报告不良事件。总之，喂食含有低乳糖和益生菌的 pHF 可能会使患有 MGD 的婴儿感到舒适，且舒适效果可能在喂养干预的头三天内早期显现。试验注册：ClinicalTrials.gov NCT04112056。
