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临床试验/NCT07114796
NCT07114796已完成不适用

Nutritional Rehabilitation of Well Nourished Children With Persistent Diarrhea and Secondary Lactose Intolerance Using Rice Based Recipes Versus Already Prescribed Lactose Free Formulas .

Children's Hospital and Institute of Child Health, Multan4 个研究点 分布在 1 个国家目标入组 320 人开始时间: 2025年1月1日最近更新:

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

Interventional, treatment based study randomized control trial 32O Well nourished children allocated in 2 groups 160 each group ,Group A on lactose free commercial formula already in use,Group B ,ON Rice based feeding recipe .

详细描述

his clinical protocol is designed to evaluate and compare the effectiveness, safety, and acceptability of different feeding interventions in well-nourished pediatric patients diagnosed with persistent diarrhea (PD) complicated by secondary lactose intolerance (SLI). The study involves the administration of both commercial lactose-free formulas and hospital-originated, modified feeding recipes (HOMF), including rice-based porridge and protein-rich preparations, over a structured treatment duration.

Persistent diarrhea is defined as the passage of three or more abnormally loose or liquid stools per day, lasting more than 14 days, in the absence of other chronic gastrointestinal diseases. Secondary lactose intolerance is confirmed based on clinical presentation and stool findings such as acidic pH (<5.5) and positive reducing substances, typically resulting from post-infectious damage to the intestinal brush border where lactase activity resides.

The protocol consists of two parallel intervention arms:

Arm A (Formula-based group): Participants receive commercially available lactose-free pediatric formulas (LFFs) such as soy-based or hydrolyzed protein formulas, prepared as per manufacturer instructions. These formulas are age-appropriate, meet the caloric needs (~80-100 kcal/kg/day), and are devoid of lactose.

Arm B (Recipe-based group): Participants are administered locally-prepared therapeutic recipes standardized in the ward kitchen. Recipes include lactose-free rice milk, along with mung dal khichdi, and chicken broth-based porridges, designed for low osmolarity (<200 mOsm/L), high digestibility, and acceptable protein content. Recipes are prepared fresh daily under sterile conditions using pre-approved kitchen protocols and nutrient calculations.

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

入选标准

  • All children admitted to hospital with persistent diarrhea and secondary lactose intolerance

排除标准

  • less than 6months primary lactose intolerance critically ill children

结局指标

主要结局

stool frequency

时间窗: day 1 to day 7 of feed

episodes of loose stool per day

次要结局

未报告次要终点

研究者

发起方
Children's Hospital and Institute of Child Health, Multan
申办方类型
Other Gov
责任方
Principal Investigator
主要研究者

Dr. Saadia Khan

principal investigator

Children's Hospital and Institute of Child Health, Multan

研究点 (4)

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