School of Public Health, Xi'an Jiaotong University Health Science Centre, Xi'an, Shaanxi, People's Republic of China.
Department of Paediatrics, The Second Affiliated Hospital of Xi'an Jiaotong University, Xi'an, Shaanxi, People's Republic of China.
BMC Pediatr. 2022 Dec 28;22(1):738. doi: 10.1186/s12887-022-03811-3.
Unreasonable use of antibiotics and probiotics can alter the gut ecology, leading to antibiotic resistance and suboptimal health outcomes during early life. Our study aims are to clarify the association among antibiotic and probiotic exposure in early life, the microecology of the gut microbiota, and the development of antibiotic resistance; to investigate the long-term impact of antibiotics and probiotics on the health outcomes of infants and young children; and to provide a theoretical basis for the rational use of antibiotics and probiotics from a life course perspective.
The study is a prospective, longitudinal birth cohort study conducted in Shaanxi Province, China from 2018 to 2024. A total of 3,000 eligible mother-child pairs will be enrolled from rural, suburban, and urban areas. The recruitment of the participants begins at pregnancy, and the newborns will be followed up for 2 years at successive timepoints: within 3 days after birth, 42 days after birth, and at 3, 6, 12, 18, and 24 months of age. Sociodemographic data, environmental exposures, dietary patterns, psychological conditions, and medical and drug histories are collected. Cognitive and behavioural development among infants and young children and questionnaires on antibiotic knowledge and behaviour among caregivers will be collected at 12 and 24 months of age. The faecal samples are collected and analysed by 16S rRNA high-throughput sequencing and quantitative PCR (qPCR) for antibiotic resistance genes.
The findings will inform antibiotic and probiotic use for pregnant women and infants and contribute to establishing rational use strategies of antibiotics and probiotics for paediatricians, health practitioners, and drug administration policy-makers.
The study was registered on the Chinese Clinical Trial Registry (ChiCTR) platform, http://www.chictr.org.cn (Record ID: ChiCTR2100047531, June 20, 2021).
不合理使用抗生素和益生菌会改变肠道生态，导致抗生素耐药性，并在生命早期导致健康状况不佳。我们的研究目的是阐明生命早期抗生素和益生菌暴露、肠道微生物群的微观生态以及抗生素耐药性发展之间的关联；研究抗生素和益生菌对婴儿和幼儿健康结果的长期影响；并从生命历程的角度为抗生素和益生菌的合理使用提供理论依据。
本研究是一项在中国陕西省进行的前瞻性、纵向出生队列研究，时间为 2018 年至 2024 年。将从农村、郊区和城市地区招募 3000 名符合条件的母婴对。参与者的招募始于妊娠，新生儿将在连续的时间点进行随访 2 年：出生后 3 天内、出生后 42 天、以及 3、6、12、18 和 24 个月时。收集社会人口统计学数据、环境暴露、饮食模式、心理状况以及医疗和药物史。在 12 和 24 个月时，对婴儿和幼儿的认知和行为发育以及照顾者的抗生素知识和行为问卷进行收集。通过 16S rRNA 高通量测序和定量 PCR（qPCR）收集粪便样本并分析抗生素耐药基因。
研究结果将为孕妇和婴儿使用抗生素和益生菌提供信息，并有助于为儿科医生、卫生从业人员和药物管理政策制定者制定合理使用抗生素和益生菌的策略。
该研究在中国临床试验注册中心（ChiCTR）平台上注册，网址为 http://www.chictr.org.cn（注册号：ChiCTR2100047531，2021 年 6 月 20 日）。
