Effect of Lactobacillus Reuteri DSM17938 in Neonates Treated With Antibiotics on Emergence of Functional Gastrointestinal Disorders, Body Composition, Mineral Bone Density and Fecal Microbiota in Infancy
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 98
- 试验地点
- 1
- 主要终点
- Composition of gut microbiota in infants - 1
研究概览
简要总结
The aim of the study is to elucidate the relationship between postnatal antibiotic administration on development of gut microbiota and possible protective influence of simultaneously administration of probiotic during antibiotic therapy on development of gut microbiota, functional gastrointestinal disorders of infancy, weight gain and body composition.
详细描述
The study is double-blind, placebo-controlled randomised trial and is composed from two parts. First part of the study aims to examine any difference in gut microbiota after postnatal antibiotic administration between the neonates who received probiotic Lactobacillus reuteri DSM 17938 or placebo and to compare the gut microbiota of patients to microbiota of healthy newborns. Second part of the study aims to determine whether probiotic L. reuteri DSM 17938 supplementation to antibiotic therapy has any beneficial influence on incidence of functional gastrointestinal disorders of infancy and body composition and bone density 6 weeks and one year after inclusion in the study.
Additionally the associations of the clinical parameters with the composition and developmental characteristics of fecal microbiota during antibiotic treatment in children will be evaluated; relevant clinical data such as mode of delivery, child's nutrition, health problems, growth and developmental attributes which could be found associated with fecal microbial community, will be tracked and statistically evaluated for the investigated population.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- — 至 21 Days（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •term neonates whom antibiotic treatment will be introduced due to clinical suspicion of infection
排除标准
- •gestational age under 37 weeks
- •birth weight less than 2500 grams
- •congenital malformations/syndromes
- •perinatal hypoxia
- •who had received probiotics before the randomization
- •have had cow's milk protein allergy diagnosed during the study
- •patient who will be treated with antibiotic for less than 5 days
研究组 & 干预措施
Intervention group
The intervention group will receive 5 drops, a minimum of 100 million live Lactobacillus reuteri DSM 17938 a day during antibiotic treatment (empirical treatment for neonatal sepsis with ampicillin and gentamicin) and 6 consecutive weeks after finishing the antibiotic treatment.
干预措施: Lactobacillus reuteri DSM 17938 (Dietary Supplement)
Intervention group
The intervention group will receive 5 drops, a minimum of 100 million live Lactobacillus reuteri DSM 17938 a day during antibiotic treatment (empirical treatment for neonatal sepsis with ampicillin and gentamicin) and 6 consecutive weeks after finishing the antibiotic treatment.
干预措施: ampicillin and gentamicin (Drug)
Placebo group
Placebo group will receive 5 drops of maltodextrin in the some oil suspension a day during antibiotic treatment (empirical treatment for neonatal sepsis with ampicillin and gentamicin) and 6 consecutive weeks after finishing the antibiotic treatment.
干预措施: Placebo (Dietary Supplement)
Placebo group
Placebo group will receive 5 drops of maltodextrin in the some oil suspension a day during antibiotic treatment (empirical treatment for neonatal sepsis with ampicillin and gentamicin) and 6 consecutive weeks after finishing the antibiotic treatment.
干预措施: ampicillin and gentamicin (Drug)
结局指标
主要结局
Composition of gut microbiota in infants - 1
时间窗: At 6 weeks after intervention
\[colony-forming units/ml; /\]
Infants crying duration time
时间窗: At 6 months of age
Questionnaire \[/\]
Composition of gut microbiota in infants - 2
时间窗: At one year of age
\[colony-forming units/ml; /\]
Functional gastrointestinal dysfunction
时间窗: At 6 months of age
Questionnaire \[/\]
次要结局
- Infant weight - 2(At 12 months of age)
- Body composition of infants - 1(At 6 months of age)
- Bone mineral density in infants - 1(At 6 months of age)
- Infant weight - 1(At 6 months of age)
- Bone mineral density in infants - 2(At 12 months of age)
- Infant height - 1(At 6 months of age)
- Infant height - 2(At 12 months of age)
- Body composition of infants - 2(At 12 months of age)
研究者
Jana Lozar Krivec
MD
University Medical Centre Ljubljana