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

Children's Hospital and Institute of Child Health, Multan

Status: Completed

Conditions: Persistent Diarrhea; Children; Severe Acute Malnutrition

Treatments: Dietary Supplement: WHO-recommended standard therapeutic milk used for stabilization phase in SAM); Dietary Supplement: HO-recommended Rice based therapeutic milk used for stabilization phase in SAM)

Study type: Interventional

Funder types: Other

Identifiers

NCT07070856

U1111-1324-6540

Details and patient eligibility

About

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.

Full 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.

Enrollment: 320 patients

Sex: All

Ages: 6 to 59 months old

Volunteers: No Healthy Volunteers

Inclusion criteria

• All the children admitted to the hospital with complaints of persistent diarrhea
• secondary lactose

Exclusion criteria

• 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 .

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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320 participants in 2 patient groups

WHO standard f75

Active Comparator group

Description:

standard ,prepared.powdered F75 by WHO

Treatment:

Dietary Supplement: WHO-recommended standard therapeutic milk used for stabilization phase in SAM)

Rice Based F75

Experimental group

Description:

Rice based F75 BY WHO recipe for PERSISTENT Diarhea

Treatment:

Dietary Supplement: HO-recommended Rice based therapeutic milk used for stabilization phase in SAM)