Description Module
The Description Module contains narrative descriptions of the clinical trial, including a brief summary and detailed description. These descriptions provide important information about the study's purpose, methodology, and key details in language accessible to both researchers and the general public.
Description Module path is as follows:
Study -> Protocol Section -> Description Module
Description Module
Ignite Creation Date:
2025-12-24 @ 11:28 PM
Ignite Modification Date:
2025-12-24 @ 11:28 PM
NCT ID:
NCT07070856
Brief Summary:
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:
1. Does rice-based F-75 reduce the duration of diarrhea and improve nutritional recovery in children with SAM?
2. 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:
1. Be children aged 6 to 59 months admitted with SAM and persistent diarrhea
2. Be randomly assigned to one of the two feeding groups
3. 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.
Detailed Description:
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.
Study:
NCT07070856
Study Brief:
Protocol Section:
NCT07070856