A Multi-center, Randomized Controlled Comparison of Three Renutrition Strategies for the Management of Moderate Acute Malnutrition Among Children From 6 to 24 Months (Madagascar, Niger, Central African Republic and Senegal)
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 1,357
- 试验地点
- 4
- 主要终点
- Recovery at three month
研究概览
简要总结
The aim of this open-label randomized controlled trial conducted in four African countries (Madagascar, Niger, Central African Republic and Senegal) is to compare three strategies of renutrition for moderate acute malnutrition (MAM) in children based on modulation of the gut microbiota with enriched flours alone, enriched flours with prebiotics or enriched flours coupled with antibiotic treatment. Cognitive development of children (Senegal) will also be studied and compared.
详细描述
The main objective of this study is to improve the nutrition strategy used to take in charge moderate acute malnutrition (MAM) which is the major milestone before severe malnutrition. This will be based on the modulation of the gut microbiota with adjunct product added to standard nutrition flours.
The purpose of the MALINEA study is to compare three management strategies for Moderate Acute Malnutrition (MAM) in children aged between 6 months and 2 years old on recovery defined by a weight/size gain at 3 months.
The 3 groups will be compared on several anthropometric measurements [Weight, length, Mid Upper Arm Circumference (MUAC)], clinical characteristics, adherence and tolerance to interventions between before and after a 3 months intervention Cognitive development of children (Senegal) will also be studied and compared, at inclusion, 3 months and 6 months after inclusion.
The investigators will also investigate the microbiomes of malnourished children at inclusion and at 3 and 6 months after inclusion to compare it to the ones of normonourished children.
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
- None
入排标准
- 年龄范围
- 6 Months 至 24 Months（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Children aged from 6 to 24 months olds.
- •Moderate acute malnutrition defined by a -3 ≤ Weight/Height z-score < -2 SD.
- •Written informed consent of parents or legal guardian.
- •Child able to be brought back to the centre on the two following days of inclusion.
- •Child able to be followed up during at least three months.
排除标准
- •Severe malnutrition defined by a mid upper arm circumference < 115 mm OR Weight/Height z-score < -3 SD OR presence of nutritional oedema.
- •Clinical complications or according to the physician any clinical sign requiring care outside of the recruitment centre (referral to specialised centre or hospitalisation)
- •Diarrhea with mucus and bloody stools.
- •Current incompatible treatment : Antacids, Cetirizine, Digoxin, Ergotamine, Azidothymidine.
- •Known hypersensitivity to macrolides or albendazole (or one of its components)
- •Known allergy to enriched flours or prebiotics used in the study, or one of its components.
研究组 & 干预措施
Control group
Fortified Blended Flour (in association with a single dose of Albendazole at inclusion for children older than 12 months).
200 grams / day for children between 6 and 11 months. 300 grams / day for children aged from 12 to 24 months old.
干预措施: Albendazole (Drug)
Control group
Fortified Blended Flour (in association with a single dose of Albendazole at inclusion for children older than 12 months).
200 grams / day for children between 6 and 11 months. 300 grams / day for children aged from 12 to 24 months old.
干预措施: Fortified blend flour (Dietary Supplement)
Azythromycin
Fortified Blended Flour (in association with a single dose of Albendazole at inclusion for children older than 12 months) associated to Azythromycin, 20mg/kgs/days during the three first days of the study.
干预措施: Azythromycin (Drug)
Azythromycin
Fortified Blended Flour (in association with a single dose of Albendazole at inclusion for children older than 12 months) associated to Azythromycin, 20mg/kgs/days during the three first days of the study.
干预措施: Albendazole (Drug)
Azythromycin
Fortified Blended Flour (in association with a single dose of Albendazole at inclusion for children older than 12 months) associated to Azythromycin, 20mg/kgs/days during the three first days of the study.
干预措施: Fortified blend flour (Dietary Supplement)
Prebiotic
Fortified Blended Flour mixed with Inuline and fructo-oligosaccharides (Synergy1) 2g/day, given to the child through the whole intervention (in association with a single dose of Albendazole at inclusion for children older than 12 months)
干预措施: Inuline and fructo-oligosaccharides (Dietary Supplement)
Prebiotic
Fortified Blended Flour mixed with Inuline and fructo-oligosaccharides (Synergy1) 2g/day, given to the child through the whole intervention (in association with a single dose of Albendazole at inclusion for children older than 12 months)
干预措施: Albendazole (Drug)
Prebiotic
Fortified Blended Flour mixed with Inuline and fructo-oligosaccharides (Synergy1) 2g/day, given to the child through the whole intervention (in association with a single dose of Albendazole at inclusion for children older than 12 months)
干预措施: Fortified blend flour (Dietary Supplement)
结局指标
主要结局
Recovery at three month
时间窗: Three month
Recovery at three months, defined by: Weight/Size Z-score ≥ -1.5 SD measured at 2 following consultations without hospitalization, transfer, death or lost to follow up
次要结局
- Comparison of the Operational Taxonomic Unit composition of stool samples according to the nutritional status(Baseline, three and six months after inclusion)
- Cognitive-motor development (Senegal)(Baseline, three, six and nine months after inclusion)