Chr. Hansen A/S, Kogle allé 6, Hørsholm 2970, Denmark.
CPS Research, 3 Acre Road, Todd Campus, Glasgow G20 0XA, United Kingdom.
Benef Microbes. 2022 Feb 28;13(1):13-23. doi: 10.3920/BM2021.0065. Epub 2021 Dec 13.
Acute upper respiratory tract infections (URTIs) are caused by numerous viruses and bacteria. URTIs can be a cause of morbidity and are among the most common reasons for visiting healthcare practitioners and prescribing antibiotics to children in addition to causing absenteeism from school and work. Oral intake of GG DSM 33156 has shown beneficial health effects in several clinical trials, primarily relating to immune function and gastrointestinal health in children and adults. It has also been suggested that oral intake of GG DSM 33156 can reduce the incidence rate and alleviate symptoms of URTIs in children. We here report the results of a randomised, double-blind, placebo-controlled trial of 619 children aged 2-6 years conducted at a single centre in Scotland. The children, who were in day care or primary school, were followed over a 16-week intervention period with 309 randomised in the active group and 310 in the placebo group. The parents or guardians reported a daily healthcare status and any presumed episodes of URTI, which were subsequently confirmed by a general practitioner. The investigational product was well tolerated in the trial. Although a general trend towards a beneficial effect was observed, this trial did not demonstrate that GG DSM 33156 significantly reduced the incidence of URTIs, diagnosed by a general practitioner according to prespecified criteria (primary endpoint). Moreover, none of the secondary efficacy endpoints were met. Applying a Ward's hierarchical clustering, two separate clusters, focussing on four quality of life-related endpoints, were identified. Cluster 1 was associated with more severe URTI characteristics than cluster 2. Cluster 2 was significantly enriched with children who consumed the product, indicating that the symptoms children experience during an URTI are alleviated by the intake of GG DSM 33156. The study is registered at ClinicalTrials.gov ID: NCT03636191.
急性上呼吸道感染（URTIs）由多种病毒和细菌引起。URTIs 可导致发病，并成为除导致儿童缺课外，儿童和医生就诊以及开具抗生素的最常见原因之一。在多项临床试验中，口服 GG DSM 33156 已显示出对健康有益的影响，主要与儿童和成人的免疫功能和胃肠道健康有关。也有人提出，口服 GG DSM 33156 可以降低儿童 URTIs 的发病率并减轻其症状。我们在此报告了一项在苏格兰的单一中心进行的、针对 619 名 2-6 岁儿童的随机、双盲、安慰剂对照试验的结果。这些在日托或小学上学的儿童在 16 周的干预期间接受了随访，其中 309 名随机分配到活性组，310 名分配到安慰剂组。父母或监护人每天报告儿童的健康状况和任何疑似 URTI 发作情况，随后由全科医生确认。试验中该研究产品的耐受性良好。尽管观察到了有益效果的一般趋势，但该试验并未表明 GG DSM 33156 显著降低了 URTIs 的发病率，这是根据预先指定的标准由全科医生诊断的（主要终点）。此外，没有达到任何次要疗效终点。应用 Ward 分层聚类法，确定了两个单独的聚类，聚焦于四个与生活质量相关的终点。聚类 1 与比聚类 2 更严重的 URTI 特征相关。聚类 2 显著富集了服用产品的儿童，表明儿童在 URTI 期间经历的症状通过摄入 GG DSM 33156 得到了缓解。该研究在 ClinicalTrials.gov 注册号为：NCT03636191。
