Assessment of the Impact of Type of Probiotic, Delivery Type and Feeding Type on Baby's Microbiota After Dysbiotic Delivery
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 120
- 试验地点
- 5
- 主要终点
- Relative abundance of bifidobacteria
研究概览
简要总结
This study aims to determine the effect of three factors (delivery type, feeding type and the use of two different dietary supplements) on rebiosis after disbiotic delivery. This is a randomized, single-blinded study with two parallel arms. Group 1 will receive L. reuteri (10^8 CFU) once a day, group 2 will receive B. longum and P. Pentosaceus (10^9 CFU) once a day.
详细描述
Gut colonization during the first days of life represents the start of the infant's own microbiota. This process is influenced by different factors: delivery type, feeding type, antibiotic treatment, etc. On the one hand, vaginally delivered babies are in contact with mother's vaginal and faecal microbiota. This fact will drive a neonatal gut colonization composed of vagina-associated bacteria. In contrast, babies born by C-section are more susceptible to be colonized by microorganisms present in the mother's skin. On the other hand, antibiotic administration during vaginal delivery also produces alterations in the vaginal microbiota of the mother. Described scenarios have been correlated to immunological and metabolic diseases such as asthma, allergies, diabetes or obesity. Moreover, disbiosis has also been associated to functional gastrointestinal disorders (FGID) in babies such as infant colic and functional constipation. After a disbiotic delivery, medical doctors usually recommend the use of probiotics to prevent rebiosis. Since the probiotics.
L. reuteri, and B. longum and P. Pentosaceus have shown efficacy on FGID amelioration in previously published articles, these two probiotics were selected for the present study. All together, this study aims to characterize the role of three different parameters: type of probiotic, delivery type and feeding type.
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
- Double (Investigator, Outcomes Assessor)
盲法说明
Both probiotic products will be provided in their commercial form. Both products will be individually placed inside opaque bags so that the investigator can not recognize the external case.
入排标准
- 年龄范围
- — 至 25 Days（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Healthy infants up to 25 days of life
- •Infants with adequate weight according to the gestational age.
- •Infants born by vaginal delivery whose mother was given antimicrobial prophylaxis or infants born by C-section.
- •Gestational birth equal or greater than 37 weeks.
- •Exclusive or almost exclusive breastfeeding (understanding almost exclusive the one in which there is a maximum of one formula feeding per day) or mixed feeding (in which there is more than one formula feeding per day).
排除标准
- •Infants with smoker mother during pregnancy and after delivery.
- •Infants whose parents cannot follow the study requirements
- •Infants who have suffered neonatal admission or have suffered or suffer necrotizing enterocolitis, infectious disease, congenital malformation, short bowel syndrome or any serious illness.
- •Infants who have taken probiotics before the start of the trial or who take formula with probiotics.
- •Breast-fed infants whose mothers have taken probiotics within the two weeks before study inclusion.
- •Infants who ingest special formulas as extensively hydrolysed formulas.
- •Breast-fed infants whose mothers have excluded dairy products and egg products in their diet during breastfeeding
- •Infants who take specific medication for the treatment of functional digestive disorders: antacids (type IBP or H2 blockers), laxatives (PEG, lactulose, magnesia), lactase and simethicone at the time of inclusion.
- •Infants undergoing therapies with acupuncture, homeopathy, medicinal herbs, anti-inflammatories and antispasmodics at the time of inclusion.
研究组 & 干预措施
B. longum and P. Pentosaceus
Group that will receive B. longum and P. Pentosaceus one dose per day in an oral suspension.
Intervention: Dietary Supplement: B. longum and P. Pentosaceus
L. reuteri
Group that will receive L. reuteri one dose per day in an oral suspension
Intervention: Dietary Supplement: L. reuteri
干预措施: L. reuteri (Dietary Supplement)
结局指标
主要结局
Relative abundance of bifidobacteria
时间窗: 1 month
Changes in the relative abundance of bifidobacteria in stool microbiota after 1 month of supplementation, measured with metagenomic techniques.
次要结局
- Number of regurgitations by questionnaire included in patients' diary(3 months)
- Number of constipation episodes by questionnaire included in patients' diary(3 months)
- Number of infant colic episodes by questionnaire included in patients' diary(3 months)
- Respiratory, gastrointestinal infections and use of medication by questionnaire included in patients' diary(3 months)
- Anxiety and depression by the validated Hospital Anxiety and Depression scale (HADS)(3 months)
- Extra visits to paediatrician/emergency by questionnaire included in the patient's diary(3 months)
- Number of Participants With Treatment-Related Adverse Events(3 months)
- Levels of IgA in faeces(1 month)
- Weight evolution by the paedatrician in study visits(3 months)
- Metagenomic analysis of total gut microbiota(1 month)
研究者
Óscar García-Algar
Principal Investigator
Fundacion Clinic per a la Recerca Biomédica