Effect of Supplementation With LNS Fortified With a Mixture of FOS and Inulin on Gut Microbiota Diversity and Functionality and Its Repercussion on Growth and Morbidity During Infancy in Rural Burkina Faso
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 153
- 试验地点
- 2
- 主要终点
- Fecal microbiota range-weighted richness
研究概览
简要总结
The purpose of this study is to assess the effect of a mixture of prebiotics included in a food supplement on microbiota diversity and functionality, and to explore its subsequent effects on linear growth velocity and morbidity.
详细描述
The central role of gut microbiota in immunity and nutritional homeostasis is now acknowledged, albeit not fully understood. Gut microbiota composition imbalances have been found in malnourished children, which were not restored by nutritional interventions as currently conducted. Therefore, the necessity to design more complete nutritional interventions that include gut health has been advised by expert committees.
Prebiotics are compound that selectively enhance the growth of beneficial gut bacteria. They have been recommended and used in infant formula and weaning cereals resulting in gut microbiota resembling that of breastfed infants in formula fed infants in developed countries. A healthy gut microbiota was shown to be associated with enhanced growth patterns and decreased morbidity in children in developed countries. Evidence of such outcome is lacking in developing countries, yet such results would be particularly valuable for children from these settings, living in rather poor sanitary conditions in an environment characterized with high infectious disease load, conditions that mostly explain the high prevalence of chronic malnutrition. This study aims to assess the effect of a 6 months' supplementation with a lipid based nutrient supplement fortified with fructo-oligosaccharides and inulin on microbiota diversity and functionality in rural Burkinabe infants, and to explore its subsequent effects on linear growth velocity and morbidity.
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)
入排标准
- 年龄范围
- 24 Weeks 至 26 Weeks（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •6-6.5 month old infants
- •Weight for height and height for age z-score above -2
- •Permanent resident of the area and not intending to move for the next 6 months for more than a week
- •No chronic antibiotic treatment
- •Exempt of any current serious illness
- •Still breastfed.
排除标准
- •Moderate or severe malnutrition (weight for height or height for age z-score below -2)
- •non-permanent residence in the study area,
- •the presence of any congenital anomalies in the child or mental/physical disease of the mother that can interfere with child feeding
- •a chronic antibiotic treatment i.e. more than 6 weeks treatment at the time of enrolment
- •a history of allergy to a constituent of the supplement
- •a serious current illness
结局指标
主要结局
Fecal microbiota range-weighted richness
时间窗: 6 months
Composition of fecal microbiota will be determined by Illumina sequencing from which range-weighted richness will be calculated
Mean concentration of short-chain fatty acids in stool
时间窗: 6 months
Concentration of short-chain fatty acids (acetate, butyrate and propionate) will be measured by Gas Chromatography
次要结局
- Calprotectin concentration in stool(at inclusion, 3 months and 6months after inclusion)
- Mean stool pH(once every week during the first month of supplementation)
- Residual fecal microbiota range-weighted richness(3 months and 6 months)
- Infant linear growth velocity(once a month during 6 months)
- Frequency of digestive intolerance symptoms (flatulence, abdominal pain, regurgitation, vomiting, or diarrhea)(once every week during the first month of supplementation)
- Stool consistency(Once every week during the first month of supplementation)
- Stool frequency per day(6 months)
- Cumulative morbidity(Starting from inclusion, weekly during a follow-up of 6 months)
- Infant ponderal growth velocity(once a month during 6 months)
- Infant's intestinal permeability(at inclusion, 3 months and 6 months after inclusion)
- Residual concentration of short-chain fatty acids in stool(3 months and 6 months)