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临床试验/NCT05936541
NCT05936541已完成不适用

Modulation of Bifidocentric Dysbiosis Through Bifidobacterium Bifidum PRL2010 Supplementation in Caesarian-born Infants

Liaquat University of Medical & Health Sciences2 个研究点 分布在 1 个国家目标入组 20 人开始时间: 2020年1月5日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
20
试验地点
2
主要终点
Number of participants with disease

研究概览

简要总结

This study is aimed to manipulate the composition of the intestinal flora of the infants born by caesarian section through the administration of the probiotic strain "Bifidobacterium bifidum PRL 2010", in order to evaluate its effects on gut dysbiosis during the first 6 month of life.

详细描述

There has been increasing interest in the field of human microbiome, considering its impact on health and diseases. The gastrointestinal tract represents the most heavily inhabited organ with microorganisms, counting 10 times the total number of human cells; for this reason, the gut microbiome has recently been referred as a proper organ. Intestinal microbial composition is unique for each individual and it is influenced by numerous factors, of which delivery mode is an important one with gestational age of the newborn, type of feeding and intrapartum or neonatal antibiotic therapy. Recent reports suggest that dysbiosis secondary to delivery mode affects the subsequent regulation of immune response and may be associated with several pathologic conditions, for example allergic diseases or obesity. Moreover, gut microbiome seems to impact on neurodevelopment during first six months of life. Bifidobacteria is the most represented group of intestinal microbiota in the newborn, followed by Enterobacteria, and it plays an important role in the infant gut. This includes the fundamental function performed by Bifidobacterium bifidum: it supplies the nutritional material to the rest of the microbial community, particularly Bifidobacterium breve and Bifidobacterium longum infantis that are the other typical bifidobacteria of the newborn. It is a powerful metabolizer of the intestinal mucus and the HMOs (Human Milk Oligosaccharides) present in breast milk. Thanks to its exocitable enzymes, the degradative catabolism occurs in the intestinal environment. Thus, B. bifidum favour the increase in intestinal richness and biodiversity (9), which correlates with the host's state of health. However, bifidobacteria is reduced in infants born by cesarean delivery.

Aim of the study is to assess if the Bifidobacterium Bifidum PRL2010 supplementation effectively ameliorat bifidocentric dysbiosis due to the delivery mode and we want to confirm this by analyzing fecal microbiota in caesarean birth infants.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
None

入排标准

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

入选标准

  • Healthy infants born by caesarian delivery
  • Parents informed written consent

排除标准

  • Suspension of the administration of the probiotic strain for a period of time exceeding 7 days
  • Interruption of the administration of the probiotic strain before the completion of the sixth month
  • Replacement of Bifidobacterium bifidum PRL2010 with another strain
  • Refusal to collect the fecal sample expressed by parents
  • Major congenital birth deformities
  • Acute illness at enrollment
  • Any condition affecting food intake or metabolism
  • Maternal mental and psychosomatic diseases

结局指标

主要结局

Number of participants with disease

时间窗: up to 6 months

Number of participants with skin, respiratory and gastrointestinal diseases assessed with a questionnaire submitted to parents

次要结局

  • Variation in children gut microbiota composition(up to 6 months)

研究者

发起方
Liaquat University of Medical & Health Sciences
申办方类型
Other
责任方
Principal Investigator
主要研究者

Dr. Amjad Khan

Professor of Clinical Biochemistry and Experimental Medicine

Liaquat University of Medical & Health Sciences

研究点 (2)

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