Department of Pathology, University of Cape Town, Anzio Road, Observatory, Cape Town, 7925, South Africa.
Institute of Infectious Disease and Molecular Medicine, University of Cape Town, Anzio Road, Observatory, Cape Town, 7925, South Africa.
BMC Complement Med Ther. 2023 Oct 18;23(1):367. doi: 10.1186/s12906-023-04208-0.
Infants who are born from mothers with HIV (infants who are HIV exposed but uninfected; iHEU) are at higher risk of morbidity and display multiple immune alterations compared to infants who are HIV-unexposed (iHU). Easily implementable strategies to improve immunity of iHEU, and possibly subsequent clinical health outcomes, are needed. iHEU have altered gut microbiome composition and bifidobacterial depletion, and relative abundance of Bifidobacterium infantis has been associated with immune ontogeny, including humoral and cellular vaccine responses. Therefore, we will assess microbiological and immunological phenotypes and clinical outcomes in a randomized, double-blinded trial of B. infantis Rosell®-33 versus placebo given during the first month of life in South African iHEU.
This is a parallel, randomised, controlled trial. Two-hundred breastfed iHEU will be enrolled from the Khayelitsha Site B Midwife Obstetric Unit in Cape Town, South Africa and 1:1 randomised to receive 8 × 10 CFU B. infantis Rosell®-33 daily or placebo for the first 4 weeks of life, starting on day 1-3 of life. Infants will be followed over 36 weeks with extensive collection of meta-data and samples. Primary outcomes include gut microbiome composition and diversity, intestinal inflammation and microbial translocation and cellular vaccine responses. Additional outcomes include biological (e.g. gut metabolome and T cell phenotypes) and clinical (e.g. growth and morbidity) outcome measures.
The results of this trial will provide evidence whether B. infantis supplementation during early life could improve health outcomes for iHEU.
Approval for this study has been obtained from the ethics committees at the University of Cape Town (HREC Ref 697/2022) and Seattle Children's Research Institute (STUDY00003679).
Pan African Clinical Trials Registry Identifier: PACTR202301748714019.
gov: NCT05923333.
Version 1.8, dated 18 July 2023.
与未感染 HIV 的婴儿（未暴露于 HIV 的婴儿，简称 iHU）相比，由 HIV 阳性母亲所生的婴儿（HIV 暴露但未感染的婴儿，简称 iHEU）发病率更高，并表现出多种免疫改变。需要采取易于实施的策略来改善 iHEU 的免疫力，并可能改善随后的临床健康结果。iHEU 的肠道微生物组组成和双歧杆菌耗竭发生改变，双歧杆菌婴儿相对丰度与免疫发生有关，包括体液和细胞疫苗反应。因此，我们将在南非 iHEU 中进行一项随机、双盲试验，评估生命的第一个月内给予罗塞尔氏双歧杆菌 Rosell®-33 与安慰剂对微生物学和免疫学表型及临床结局的影响。
这是一项平行、随机、对照试验。将从南非开普敦 Khayelitsha Site B 助产士产科病房招募 200 名母乳喂养的 iHEU，并将其 1:1 随机分为接受 8×10 CFU 罗塞尔氏双歧杆菌 Rosell®-33 每日或安慰剂治疗，疗程为生命的前 4 周，从生命的第 1-3 天开始。婴儿将在 36 周内进行广泛的元数据和样本收集。主要结局包括肠道微生物组组成和多样性、肠道炎症和微生物易位以及细胞疫苗反应。其他结局包括生物学（如肠道代谢组和 T 细胞表型）和临床（如生长和发病率）结局指标。
该试验的结果将提供证据，证明生命早期补充罗塞尔氏双歧杆菌是否可以改善 iHEU 的健康结局。
该研究已获得南非开普敦大学伦理委员会（HREC Ref 697/2022）和西雅图儿童研究所的批准（STUDY00003679）。
泛非临床试验注册中心标识符：PACTR202301748714019。
gov：NCT05923333。
2023 年 7 月 18 日第 1.8 版。
