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临床试验/NCT04628819
NCT04628819终止不适用

Effect and Tolerability of Lactobacillus Rhamnosus GG LA801 for the Preventive Nutritional Care of Nosocomial Diarrhea in Children

PiLeJe2 个研究点 分布在 1 个国家目标入组 61 人开始时间: 2019年12月29日最近更新:
适应症

试验速览

阶段
不适用
状态
终止
发起方
PiLeJe
入组人数
61
试验地点
2
主要终点
incidence of nosocomial diarrhea

研究概览

简要总结

One of the most common infections acquired in hospital, also known as nosocomial infections, is intestinal infections. These infections can lead to the development of nosocomial diarrhea which can have serious consequences in young / very young children. These infections tend to prolong the average length of hospital stay of this fragile population. Conventional treatment of these infections, in the absence of knowledge of the infectious agent, is purely symptomatic. It is therefore necessary to develop new prevention strategies for this type of disease. In this sense, the administration of probiotic strains in order to prevent the onset of nosocomial diarrhea is a promising avenue and the present study aims to validate the preventive effect of this supplement.

The objective of this study is to assess the effect of Babybiane® Imedia or the microbiotic strain Lactobacillus rhamnosus GG LA801 in the preventive nutritional management of nosocomial diarrhea in children aged 1 to 24 months. This evaluation will be made in comparison with a placebo. The tolerance of the product under study will also be assessed.

详细描述

Diarrhea in children According to the World Health Organization, diarrhea is defined by the release of at least three loose or watery stools per day or with an abnormal frequency for a single individual. It is generally a symptom of gastrointestinal infection who might be of bacterial or viral, parasite origin. Acute diarrhea is a frequent pathology, with an infectious origin in most of the cases, especially viruses and bacteria in industrialized countries. It leads to a risk of acute dehydration, in particular in high-risk populations as newborns, infants and toddlers.

Acute diarrhea is still the second leading cause of infection-associated death of children under five worldwide and in 2011 it was estimated to account for almost 10 % of the 7 million deaths in that population. In European countries, most cases show only mild or moderate symptoms and fatal outcomes are very uncommon. However gastroenteritis is still one of the main reasons for hospitalization of children in this region. In Europe, the incidence or diarrhea ranges from 0.5 to 2 episodes per year in children under 3 years old. Dehydration secondary to an acute diarrhea is still one of the main cause of death in young children that could be prevented in industrialized countries. Acute diarrhea is mostly associated with acute gastroenteritis, which is one of the main reason for hospitalization of children under 3 but it is also associated with antibiotics therapy (Antibiotics Associated Diarrhea or AAD) or hospital-acquired infections.

Hospital-acquired or nosocomial diarrhea (ND) Infections occurring more than 48 hours after hospital admission are usually considered as nosocomial infections. The incidence of this kind of infections among children in the industrialized countries remains very high, ranging from 5.1% to 11.6% depending on the time of the year and the type of hospital. In children, gastrointestinal infections account for the majority of the hospital-acquired infections and rotavirus is the main pathogenic agent. Those infections can lead to nosocomial diarrhea and therefore have numerous health and economic consequences as they tend to prolong hospital stay and mortality. Moreover nosocomial infections are usually treated with broad spectrum antibiotics without knowing the type of bacteria responsible for the infection or its antibiogram. This results in the selection of resistant microorganisms leading to increased antimicrobial resistance. All these factors combine for an increase of the financial burden of the healthcare system due to nosocomial infections. Nosocomial infections are more prevalent in the pediatric population than in the adult population and predominantly occur in intensive care units (ICU). In settings other than the ICU, the most common pediatric nosocomial infection is gastroenteritis. Rotavirus and norovirus account for the vast majority of the hospital-acquired gastroenteritis. Although, regular precautions such as hand hygiene or isolation of sick patients can prevent the spread of the infections, there is a clear need for new prevention strategies, and among those the use of probiotics is a promising one.

Probiotics and nosocomial diarrhea It is important to consider that no broad consensus exists to recommend the use of probiotics in the prevention of diarrhea, mainly because of the different design of the studies done so far. Therefore, there is a need for more well-designed studies before recommendations can be proposed.

However, three systematic reviews have assessed the efficacy of probiotics supplementation in the prevention of nosocomial diarrhea for a total of eight randomized clinical trials (RCT) involving a grand total of 2 254 children for the age of 1 month to 18 years old.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Prevention
盲法
Triple (Participant, Care Provider, Investigator)

盲法说明

The patients, their parents and the investigators will not know the treatment taken by the patient. Unblinding will be performed at the end of the study.

入排标准

年龄范围
1 Month 至 24 Months(Child)
性别
All
接受健康志愿者

入选标准

  • Informed consent signed by the patient's legal guardian(s) for study enrollment;
  • Aged 1 to 24 months ;
  • Admitted to the hospital for reasons other than diarrhea;
  • Stayed in the Short Stay Unit, SSU, for a minimum duration of 6h.

排除标准

  • With history of gastroenteritis in the 2 weeks before hospitalization;
  • With symptoms suggesting an ongoing gastroenteritis or other intestinal disease;
  • Use of probiotics or prebiotics within 7 days before admission;
  • With immunodeficiency, neoplasm or chronic severe illnesses;
  • With a previous hospitalization within 15 days;
  • With an history of digestive surgery;
  • For whom an oral route is impossible;
  • Participating at the same time in another clinical trial.

结局指标

主要结局

incidence of nosocomial diarrhea

时间窗: during seven days of supplementation

The primary endpoint is the comparison of the incidence of nosocomial diarrhea (defined as the passage of 3 or more loose or watery stools in a 24-hour period (or more frequently than is normal for the individual) that occurred between 48 hours to 7 days after admission) between the 2 groups (BABYBIANE® Imedia vs. placebo) during 7 days of supplementation.

次要结局

  • time to onset of nosocomial diarrhea(During study duration (14 days))
  • number of nosocomial diarrhea(During study duration (14 days))
  • nosocomial diarrhea duration(During study duration (14 days))
  • incidence of diarrhea(During study duration (14 days))
  • length of hospital stay(During study duration (14 days))
  • number of care visits(During study duration (14 days))
  • length of day care missed(During study duration (14 days))
  • time to onset of diarrhea(During study duration (14 days))
  • number of loose or watery stools(During study duration (14 days))
  • diarrhea duration(During study duration (14 days))
  • incidence of recurrent diarrhea(During study duration (14 days))
  • incidence of need for and length of rehydration because of diarrhea(During study duration (14 days))
  • length of work missed by parent or guardian(During study duration (14 days))
  • adverse events(During study duration (14 days))
  • Complementation intake(During study duration (14 days))
  • other symptoms presence(During study duration (14 days))
  • rotavirus, viral or bacterial pathogens' presence on stools(During study duration (14 days))

研究者

发起方
PiLeJe
申办方类型
Industry
责任方
Sponsor

研究点 (2)

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