NCT07070856

Trial of Rice-Based F-75 in Severe Malnutrition & Persistent Diarrhea in Children (SAM-RICE Study)

Efficacy and Safety of Therapeutic Rice Based F75 In Severely Acute Malnourished Children With Persistent Diarrhea.;A Randomized Control Trial.

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 320 (actual)
• Sponsor: Children's Hospital and Institute of Child Health, Multan · Other Government
• Sex: All
• Age: 6 Months – 59 Months
• Healthy volunteers: Not accepted

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.

Conditions

• Severe Acute Malnutrition
• Persistent Diarrhea
• Children

Interventions

Type	Name	Description
DIETARY_SUPPLEMENT	WHO-recommended standard therapeutic milk used for stabilization phase in SAM)	F75 GIVEN INITIALLY 2HOURLY,130 ml per kg than 3 and 4hourly maximum takes 5 to 7 days.
DIETARY_SUPPLEMENT	HO-recommended Rice based therapeutic milk used for stabilization phase in SAM)	Rice based F75 GIVEN INITIALLY 2HOURLY,130 ml per kg than 3 and 4hourly maximum takes 5 to 7 days.

Timeline

• Start date: 2024-12-31
• Primary completion: 2025-05-31
• Completion: 2025-05-31
• First posted: 2025-07-17
• Last updated: 2025-08-24

Locations

2 sites across 1 country: Pakistan