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Probiotic Supplementation to Improve the GUT Microbiota of Very Low Birth Weight Preterm, a Pilot Study

2014年7月16日 更新者:Esperanza Escribano、Hospital Universitario La Paz

Probiotic Supplementation to Improve the GUT Microbiota of Very Low Birth Weight, a Pilot Study

This pilot trial is designed to investigate the benefits of the use of probiotics in GUT microbiota development and/or immunological biomarkers and how this can be related with the clinical status of very low birth weight preterms during their first weeks of life at the neonatal intensive care unit(NICU).

研究概览

详细说明

This pilot trial is designed to investigate the benefits of the use of mixtures of probiotics isolated from human milk in GUT microbiota development and/or immunological biomarkers. Furthermore, the relationship between evaluated parameters and the clinical status of very low birth weight preterms during their first weeks of life at the NICU will be analysed.

研究类型

介入性

注册 (实际的)

5

阶段

  • 第一阶段早期

联系人和位置

本节提供了进行研究的人员的详细联系信息,以及有关进行该研究的地点的信息。

学习地点

      • Madrid、西班牙、28046
        • Hospital Universitario La Paz

参与标准

研究人员寻找符合特定描述的人,称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。

资格标准

适合学习的年龄

1小时 至 1周 (孩子)

接受健康志愿者

不

有资格学习的性别

全部

描述

Inclusion Criteria:

  • preterm infants with birth weight less than one thousand and three hundred grammes
  • preterm infants with gestational age less than 29 weeks

Exclusion Criteria:

  • mayor malformations
  • chromosomopathies
  • congenital infections
  • non parental consent

学习计划

本节提供研究计划的详细信息,包括研究的设计方式和研究的衡量标准。

研究是如何设计的?

设计细节

  • 分配:不适用
  • 介入模型:单组作业
  • 屏蔽:无(打开标签)

武器和干预

参与者组/臂
干预/治疗
其他:Probiotics supplementation
Five very low birth weight (VLBW) infants enrolled within 2 days of birth, with a weight < 1300 g and gestational age < 29 weeks and without any malformation or metabolic disease at birth were supplemented with two daily doses of a mixture of "Bifidobacterium breve" and "Lactobacillus salivarius" , probiotic strains isolated from human milk during their first weeks of life. The lyophilized powder has contained at least 1x10^9 colony forming units (CFU) per doses of each one of the probiotic bacteria.
blood and fecal samples were collected from five VLBW preterms which were supplemented with a probiotic mixture of Bifidobacterium breve / Lactobacillus salivarius isolated from human milk
其他名称:
  • "Bifidobacterium breve / Lactobacillus salivarius mixture"

研究衡量的是什么?

主要结果指标

结果测量
措施说明
大体时间
changes in microbiological counts in feces of preterm infants
大体时间:prior to initiate and at 7th, 14th, 21th, 28th days receiving probiotics
Adequate dilutions of meconium and stool samples were spread onto general and selective culture media for the enumeration of different bacterial species. Identification of isolates was carried out by matrix-assisted laser desorption ionization-time of flight (MALDI-TOF) mass spectrometry.
prior to initiate and at 7th, 14th, 21th, 28th days receiving probiotics

次要结果测量

结果测量
措施说明
大体时间
concentration of immunological parameters on feces
大体时间:prior to star and at 7th, 14th and 21st days of receiving probiotics
multiplex methodology and enzyme-Linked ImmunoSorbent Assay (ELISA) were used to determine a wide range of immune compounds and calprotectin as immune system status biomarkers: immunoglobulin(Ig) G1, IgG2, IgG3, IgG4, IgM, IgA, interleukin (IL)-1b, IL-6, IL-12,interferon-gamma, Tumor necrosis factor-alpha,IL-2,IL-4,IL-10, IL-13, IL-17, IL-8, growth related oncogene- alpha, macrophages chemoattractant protein-1, macrophage inflammatory protein-1b, IL-5, IL-7, granulocytemacrophage -colony stimulating factor (GM-CSF), granulocyte-colony stimulating factor (G-CSF).
prior to star and at 7th, 14th and 21st days of receiving probiotics
concentration of immunological parameters on plasma samples
大体时间:7th, 14th, 19th and 24th days of receiving probiotic).
multiplex methodology and enzyme-Linked ImmunoSorbent Assay (ELISA) were used to determine a wide range of immune compounds and calprotectin as immune system status biomarkers: immunoglobulin(Ig) G1, IgG2, IgG3, IgG4, IgM, IgA, interleukin (IL)-1b, IL-6, IL-12,interferon-gamma, Tumor necrosis factor-alpha,IL-2,IL-4,IL-10, IL-13, IL-17, IL-8, growth related oncogene- alpha, macrophages chemoattractant protein-1, macrophage inflammatory protein-1b, IL-5, IL-7, granulocytemacrophage -colony stimulating factor (GM-CSF), granulocyte-colony stimulating factor (G-CSF).
7th, 14th, 19th and 24th days of receiving probiotic).

其他结果措施

结果测量
措施说明
大体时间
clinical features during NICU stay
大体时间:during NICU stay, arround 1 moth

medical staff registered all the clinical status of the enrolled infants, after that the most relevant morbidity parameters associated to prematurity were factorized and evaluated by the clinicians, prior to evaluate the possible relationships with the other outcomes measured.

-Necrotizing enterocolitis, late onset sepsis, intestinal motility evaluated by feeding tolerance and determination ot total gastrointestinal transit time by the administration of carmin red, type of feeding, respiratory support, intraventricular hemorrhage. Describe healthy status of each preterm

during NICU stay, arround 1 moth

合作者和调查者

在这里您可以找到参与这项研究的人员和组织。

调查人员

  • 首席研究员:Miguel Saenz de Pipaon, PhD. MD.、Hospital Universitario La Paz

研究记录日期

这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查,以确保它们在发布到公共网站之前符合特定的质量控制标准。

研究主要日期

学习开始

2012年12月1日

初级完成 (实际的)

2013年2月1日

研究完成 (实际的)

2014年7月1日

研究注册日期

首次提交

2014年6月24日

首先提交符合 QC 标准的

2014年7月16日

首次发布 (估计)

2014年7月17日

研究记录更新

最后更新发布 (估计)

2014年7月17日

上次提交的符合 QC 标准的更新

2014年7月16日

最后验证

2014年7月1日

更多信息

与本研究相关的术语

其他研究编号

  • HULP3551
  • Universidad Complutense Madrid (其他标识符:Academic)

此信息直接从 clinicaltrials.gov 网站检索,没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求,请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改,我们的网站上也会自动更新.

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