Efficacy and Safety of Therapeutic Rice Based F75 In Severely Acute Malnourished Children With Persistent Diarrhea.;A Randomized Control Trial.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 320
- 试验地点
- 4
- 主要终点
- stool frequency
研究概览
简要总结
The goal of this study is to find out if a rice-based version of the F-75 therapeutic food helps children with severe acute malnutrition (SAM) and persistent diarrhea recover better than the standard commercial F-75.
The main questions it aims to answer are:
- Does rice-based F-75 reduce the duration of diarrhea and improve nutritional recovery in children with SAM?
- Is rice-based F-75 as safe and well-tolerated as the standard WHO F-75?
Researchers will compare two groups:
One group will receive the new rice-based F-75. The other group will receive the standard F-75.
Participants will:
- Be children aged 6 to 59 months admitted with SAM and persistent diarrhea
- Be randomly assigned to one of the two feeding groups
- Stay in a hospital ward for monitoring during the stabilization phase
Be assessed daily for:
Stool frequency Weight changes Appetite Medical problems or side effects
This study will help determine whether the rice-based F-75 is a better option for malnourished children with diarrhea.
详细描述
Persistent diarrhea in children with severe acute malnutrition (SAM) poses a significant clinical challenge, particularly during the stabilization phase. Standard therapeutic protocols include the use of F-75-a milk-based formula designed to meet the reduced metabolic demands of severely malnourished children. However, lactose content in milk-based F-75 may exacerbate intestinal symptoms in children with secondary lactase deficiency, commonly observed in cases of persistent diarrhea.
Rice-based therapeutic formulations have emerged as promising alternatives, potentially offering superior gastrointestinal tolerance, improved nutrient absorption, and reduced osmolarity compared to conventional milk-based F-75. Rice is hypoallergenic, low in anti-nutritional factors, and contains resistant starches that may support gut integrity and microbial balance during intestinal recovery.
Introducing rice-based F-75 may address dietary intolerance in children with diarrhea-induced lactase deficiency, particularly in low-resource settings where commercial lactose-free preparations are unavailable or unaffordable. This trial seeks to assess whether therapeutic feeding with rice-based F-75 leads to faster stabilization without compromising metabolic safety or nutritional adequacy.Participants are randomized into intervention and control arms during hospitalization, receiving either rice-based or conventional F-75 during the stabilization phase. Transition to F-100 occurs per clinical criteria once acute symptoms resolve.
Clinical monitoring includes:
- Gastrointestinal Tolerance: Stool frequency, consistency, abdominal distension, emesis, and need for additional rehydration.
- Metabolic Safety: Serum sodium, potassium, bicarbonate, and creatinine levels evaluated at baseline and mid-stabilization.
- Nutritional Stabilization: Daily weight, mid-upper arm circumference (MUAC), and feeding tolerance.
- Adverse Events Surveillance: Identification of allergic responses, metabolic complications, or mortality.
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
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 6 Months 至 59 Months（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •All the children admitted to the hospital with complaints of persistent diarrhea
- •secondary lactose
排除标准
- •All the children with primary lactose intolerance
- •Those parents /guardians refused permission to participate in the study.
- •Critically ill child admitted to ICUs and emergency department.
- •Patients started therapeutic feeding prior to recruitment in study .
结局指标
主要结局
stool frequency
时间窗: day 1 to day 7 of starting therapeutic feed
episodes of loose stools per day
次要结局
未报告次要终点
研究者
Dr. Saadia Khan
Pricipal Investigator
Children's Hospital and Institute of Child Health, Multan