Efficacy of Microbiota-Directed Food in Children With Moderate Acute Malnutrition in Dhaka, Bangladesh
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 230
- 试验地点
- 1
- 主要终点
- Mean change in Weight-for-Length Z-score (WLZ)
研究概览
简要总结
Moderate acute malnutrition (MAM) refers to a condition characterized by a significant deficit in weight-for-length measurements in children aged 6 to 59 months. It is a crucial public health concern with detrimental effects on child growth, development, and overall well-being. Addressing MAM is crucial to prevent its progression to severe acute malnutrition (SAM) and to ensure healthy child development. To meet the nutritional requirement of MAM children, icddr,b have come up with a novel intervention named microbiota-directed food (MDF), a ready-to-use supplementary food. The investigator propose this efficacy trial to establish the evidence on the effect of this novel intervention on ponderal growth, microbial and proteomic recovery among the children with MAM in comparison to the standard RUSF.
详细描述
Burden: Moderate acute malnutrition (MAM) refers to a condition characterized by a significant deficit in weight-for-length measurements in children aged 6 to 59 months. It is a crucial public health concern with detrimental effects on child growth, development, and overall well-being. Addressing MAM is crucial to prevent its progression to severe acute malnutrition (SAM) and to ensure healthy child development. MAM affects a significant number of children globally, particularly in low- and middle-income countries where malnutrition is prevalent. According to the 2022 Bangladesh Demographic and Health Survey (2022 BDHS), 24% of children under the age of 5 are stunted, while 11% are wasted. The prevalence of worldwide MAM children is higher than that of children with SAM and 31.3 million under 5 children (~70%) was moderately wasted among all those children who were acutely malnourished in 2022. MAM children are found to be suffering from relative gut microbial immaturity, which is related to their growth faltering. Ready-to-use supplementary food (RUSF) is a key component of the outpatient treatment of MAM in community-based management. RUSF, being a ready-to-use food, does not require preparation or refrigeration and provides the necessary nutrients and energy for recovery from MAM.
Knowledge gap: Researchers at icddr,b in collaboration with Washington University in St. Louis, have developed a Microbiota-Directed Complementary Food (MDCF) formulation (based on locally available food ingredients) that has the potential to repair the gut microbiota of children with malnutrition. Results from a recently conducted study of MDCF on Bangladeshi children suffering from MAM showed that the children who received the food exhibited significantly faster rates of ponderal growth compared to those treated with a standard ready-to-use supplementary food (PR#18073). Early evidence, however, is limited to a small sample of children with MAM.
Relevance: To meet the nutritional requirement of MAM children, icddr,b have come up with a novel intervention named microbiota-directed food (MDF), a ready-to-use supplementary food by modifying the original MDCF recipe to meet the nutritional requirement of MAM children as well as to make it align with the existing WHO/UNICEF specifications for a nutritional intervention for treating acute malnutrition. The proposed formulation of MDF with adequate calorie content will improve the nutritional status by modulating and improving the gut microbial dysbiosis that is present in MAM children. Therefore, the investigator propose this efficacy trial to establish the evidence on the effect of this novel intervention on ponderal growth, microbial and proteomic recovery among the children with MAM in comparison to the standard RUSF.
Hypothesis (if any):
The locally developed MDF would be proven beneficial in nutritional recovery, repairing microbiota and restoring plasma biomarkers of healthy growth when compared to standard RUSF among children suffering from MAM.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
盲法说明
Double blind
入排标准
- 年龄范围
- 6 Months 至 24 Months（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Parent(s) willing to sign consent form
- •Children aged 6-24 months
- •WLZ score <-2 to ≥-3 and/or MUAC ≥115 mm to <125 mm without bilateral pedal edema at the time of randomization
排除标准
- •Medical conditions: Malnourished children with complications requiring acute phase treatment in a hospital, children with tuberculosis or any chronic illness(es).
- •Any congenital/acquired disorder affecting growth, i.e., known case of trisomy-21 or cerebral palsy; children on an exclusion diet for the treatment of persistent diarrhea; having known history of soy, peanut or milk protein allergy
- •Severe anaemia (< 8 gm/dl)
- •Antibiotic use (within last 7 days before the onset of intervention)
- •Receiving concurrent treatment for another condition
- •children participating in other food intervention program
结局指标
主要结局
Mean change in Weight-for-Length Z-score (WLZ)
时间窗: Baseline to 12 weeks of intervention followed by 12 weeks of follow-up
In this study, nutritional status will be assessed through anthropometric measurement before enrolment, then biweekly till completion of intervention and monthly during 12 weeks follow up.
次要结局
- Mean change in body composition (% body fat mass and % fat-free mass)(Baseline to 12 weeks of intervention)
- Microbial community repair(Baseline to 12 weeks of intervention followed by 12 weeks of follow-up)
- Validated plasma and faecal biomarkers of health status (prioritized Luminex/ELISA panel including mediators of growth, systemic inflammation, gut inflammation/entero-pathogen burden)(Baseline to 12 weeks of intervention followed by 12 weeks of follow-up)
- Mean change in Weight-for-Age Z-score (WAZ)(Baseline to 12 weeks of intervention followed by 12 weeks of follow-up)
- Mean change in Length-for-Age Z-score (LAZ)(Baseline to 12 weeks of intervention followed by 12 weeks of follow-up)
- Bayley Scales of early childhood development (cognitive, motor, language development)(Baseline to 12 weeks of intervention)