Proof-of-Concept Study for a Microbiota-Directed Food in Children With Uncomplicated Severe Acute Malnutrition in Rural Bangladesh
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 256
- 试验地点
- 2
- 主要终点
- Mean change in Weight-for-Length Z-score (WLZ)
研究概览
简要总结
Severe acute malnutrition (SAM) 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 SAM is crucial to prevent its progression to other childhood morbidity and mortality and to ensure healthy child development. To meet the nutritional requirement of SAM children, icddr,b have come up with a novel intervention named microbiota-directed food (MDF), a ready-to-use therapeutic food. The investigators propose this proof-of-concept trial to establish evidence on the effect of this novel intervention on ponderal growth, microbial and proteomic recovery among the children with SAM in comparison to the standard RUTF.
详细描述
Burden: As per Global Nutrition report 2021, 45.4 million children under the age of 5 years were reported to be wasted. Asia is a home to more than three-quarters of all these children suffering from wasting. According to Bangladesh Multiple Indicator Cluster Survey 2019 around 10% under 5 children were wasted, while 2.3% suffered from severe form of wasting also known as severe acute malnutrition (SAM). SAM is defined by the World Health Organization (WHO) as weight-for-length Z score (WLZ) of less than -3 and/or presence of bilateral pedal edema and/or a mid-upper arm circumference less than 115 mm.
SAM children are found to be suffering from relative gut microbial immaturity, which is related to their growth faltering. Ready-to-use therapeutic food (RUTF) is a key component of the treatment protocol for SAM children and is widely used throughout the world. Which however is found to be partially effective or ineffective in repairing the gut microbial immaturity present in SAM children. To combat this, affordable therapeutic food formulation is needed that can be used to treat acute malnutrition in children with the potential to restore gut microbial colony related to growth and early childhood development.
Knowledge gap: Researchers at icddr,b in collaboration with Washington University in St. Louis has developed a Microbiota-Directed Complementary Food (MDCF) formulation (based on locally available food ingredients) that has the potential of repairing the gut microbiota of children with malnutrition. Results from a recently conducted study of MDCF on Bangladeshi children suffering from moderate acute malnutrition (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. Early evidence, however, is limited to a small sample of children with MAM. This leaves a paucity of data on the role of microbiota directed food interventions on the nutritional as well as microbial recovery and proteomic improvement in children with SAM.
Relevance: To meet the nutritional requirement of SAM children, researchers have come up with a novel intervention named Microbiota-Directed Food (MDF), a ready-to-use therapeutic food by modifying the original MDCF recipe to meet the nutritional requirement of SAM 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 MDF with a relatively lower calorie content will improve the nutritional status by modulating and improving the gut microbial dysbiosis that is present in SAM children. Therefore, the investigators propose this POC trial to generate evidence on the effect of the novel intervention on the ponderal growth, microbial and proteomic recovery among the children with SAM in comparison to the standard RUTF.
Hypothesis: The locally developed MDF would be proven beneficial in nutritional recovery, repairing gut microbiota and restoring plasma biomarkers of healthy growth when compared to standard RUTF among children suffering from SAM.
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
- •The trial will include SAM children of either sex without any medical complication
- •Children aged between 6-<24 months and with MUAC <115 mm and/or WLZ <-3
排除标准
- •Children are not suffering from SAM.
- •Children with bi-pedal oedema.
- •Failed to obtain consent for study participation from parents or legal guardian.
- •Suffering from any chronic illness(es) or having severe anemia (< 8 g/dl).
- •History of using antibiotics in the past seven days.
- •Children participating in other food intervention programs.
- •Children having known history of soy, peanut or milk protein allergy.
- •Children who will not pass appetite test.
研究组 & 干预措施
Microbiota Directed Food (MDF)
Each participant will receive 12 weeks of MDF supplement. After finishing the intervention phase, he/she will be followed-up for a 12-month period.
干预措施: Microbiota-Directed Food (Dietary Supplement)
Ready-to-Use Therapeutic Food (RUTF)
Each participant will receive 12 weeks of RUTF supplement. After finishing the intervention phase, he/she will be followed-up for a 12-month period.
干预措施: Ready-to-Use Therapeutic Food (Dietary Supplement)
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 months of follow-up
In this study, nutritional status will be assessed through anthropometric measurement at enrolment, every two weeks interval during the intervention phase and then monthly for the first three months of the follow up period and then at three monthly for the rest of the period until end of the study.
次要结局
- Improvement in the levels of plasma protein biomarkers of healthy growth(Baseline to 12 weeks of intervention followed by 12 months of follow-up)
- Mean change in Length-for-Age Z-score (LAZ)(Baseline to 12 weeks of intervention followed by 12 months of follow-up)
- Mean change in Weight-for-Age Z-score (WAZ)(Baseline to 12 weeks of intervention followed by 12 months of follow-up)
- Gut microbial community repair(Baseline to 12 weeks of intervention followed by 12 months of follow-up)
- Mean change in body composition (% body fat mass and % fat-free mass)(Baseline to 12 weeks of intervention followed by 3 months of follow-up)