Journal of Clinical Pediatrics >

2023 , Vol. 41 >Issue 1: 34 - 41

DOI: https://doi.org/10.12372/jcp.2023.22e1095

General Report

Efficacy and safety of lactase additive in preterm infants with lactose intolerance: a prospective, multi-center, randomized controlled trial

  • Xinyi ZHA ,
  • Yiwen WANG ,
  • Pengliang MAO ,
  • Mingyan CHEN ,
  • Wei JIANG ,
  • Huawei WANG ,
  • Xuefeng HU ,
  • Liping SHI ,
  • Xueping ZHU ,
  • Jihong QIAN
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  • 1. Department of Neonatology, Xinhua Hospital Affiliated to Shanghai Jiao Tong University School of Medicine, Shanghai 200092, China
    2. Department of Neonatology, Shanghai First Maternity and Infant Hospital, Shanghai 201204, China
    3. Neonatal Intensive Care Unit, The Children’s Hospital, Zhejiang University of Medicine, Hangzhou 310003, Zhejiang, China
    4. Department of Neonatology, Children’s Hospital of Soochow University, Suzhou 215025, Jiangsu, China

Received date: 2022-08-15

  Online published: 2023-02-16

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Abstract

Objective To explore the efficacy and safety of lactase additive in improving lactose intolerance in premature infants. Methods Preterm infants with lactose intolerance admitted to Xinhua Hospital Affiliated to Shanghai Jiao Tong University School of Medicine, Shanghai First Maternal and Infant Health Hospital, Children's Hospital Affiliated to Zhejiang University School of Medicine and Children's Hospital Affiliated to Soochow University from January 2018 to December 2019, who met the inclusion criteria were included in the study. They were divided into lactase treatment group and control group randomly, with 80 cases in each group. For the patients in the lactase treatment group, 4 drops (180 mg) of lactase were added to each feeding of breast milk or formula milk for premature infants, and Bifidobacterium triple viable powder was orally administered and abdominal massage was used as adjuvant therapy. For patients in the control group, 4 drops (180 mg) of placebo were added to each feeding, and the same probiotics and abdominal massage as the treatment group were given, After 1 and 2 weeks treatment, symptoms of lactose intolerance, weight, fecal pH, fecal reducing sugar and other indicators were compared between the two groups. Results seventy-eight patients in the lactase treatment group and 77 patients in the control group, respectively, completed the whole study. After the first week intervention, the positive rate of reducing sugar in the lactase treatment group was lower than that in the control group (P<0.05). At the end of the second week treatment, the proportion of abdominal distension in the lactase treatment group were lower than those in the control group (P<0.05), and the positive rate of reducing sugar was lower than that in the control group (P<0.05). The increase of feeding amount was also higher than that of the control group (P<0.05). During the course of the study, no adverse reactions to lactase additives or probiotics were found in both groups. Conclusions Lactase supplementation can effectively and safely improve the clinical symptoms caused by lactose intolerance in premature infants.

Key words： lactose intolerance; lactase supplement; safety; efficacy; premature infant

Cite this article

Xinyi ZHA , Yiwen WANG , Pengliang MAO , Mingyan CHEN , Wei JIANG , Huawei WANG , Xuefeng HU , Liping SHI , Xueping ZHU , Jihong QIAN . Efficacy and safety of lactase additive in preterm infants with lactose intolerance: a prospective, multi-center, randomized controlled trial[J]. Journal of Clinical Pediatrics, 2023 , 41(1) : 34 -41 . DOI: 10.12372/jcp.2023.22e1095

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