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

NCT07070856 | Completed

• 1 other identifier: U1111-1324-6540
• Study Type: interventional
• Target: 320
• Locations: 1 country
• Sites: 2

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. 1.Does rice-based F-75 reduce the duration of diarrhea and improve nutritional recovery in children with SAM?
2. 2.Is rice-based F-75 as safe and well-tolerated as the standard WHO F-75?
3. 3.Be children aged 6 to 59 months admitted with SAM and persistent diarrhea
4. 4.Be randomly assigned to one of the two feeding groups
5. 5.Stay in a hospital ward for monitoring during the stabilization phase

Conditions

Severe Acute Malnutrition; Persistent Diarrhea; Children

Keywords

Severe Acute Malnutrition; Persistent Diarrhea; F-75 Formula; Rice-Based Diet; Nutritional Rehabilitation; Protein-Energy Malnutrition; Lactose intolerance

Outcome Measures

Primary Outcomes (1)

• stool frequency

  episodes of loose stools per day

  day 1 to day 7 of starting therapeutic feed

Other Outcomes (3)

• hydration status

  day 1 to day 7 of treatment

• Re feeding syndrome

  Day 1 to day 7 of treatment with therapeutic feed

• Electrolytes monitoring

  Time Frame: Baseline and Day 4

Study Arms (2)

WHO standard f75

ACTIVE COMPARATOR

standard ,prepared.powdered F75 by WHO

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

Rice Based F75

EXPERIMENTAL

Rice based F75 BY WHO recipe for PERSISTENT Diarhea

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

Interventions

WHO-recommended standard therapeutic milk used for stabilization phase in SAM) DIETARY_SUPPLEMENT

F75 GIVEN INITIALLY 2HOURLY,130 ml per kg than 3 and 4hourly maximum takes 5 to 7 days.

Also known as: Stabalization phase feed

WHO standard f75

HO-recommended Rice based therapeutic milk used for stabilization phase in SAM) DIETARY_SUPPLEMENT

Rice based F75 GIVEN INITIALLY 2HOURLY,130 ml per kg than 3 and 4hourly maximum takes 5 to 7 days.

Rice Based F75

Eligibility Criteria

• Age: 6 Months - 59 Months
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

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

You may not qualify if:

• 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 .

Sponsors & Collaborators

• Children's Hospital and Institute of Child Health, Multan: lead

Study Sites (2)

Tehsil Head Quater Sujah Abad

Multan Khurd, Punjab Province, 60000, Pakistan

Location

The Childrens Hospital and Instotute of Child Health Multan

Multan Khurd, Punjab Province, 60000, Pakistan

Location

Related Publications (1)

• Facioni MS, Raspini B, Pivari F, Dogliotti E, Cena H. Nutritional management of lactose intolerance: the importance of diet and food labelling. J Transl Med. 2020 Jun 26;18(1):260. doi: 10.1186/s12967-020-02429-2.

  PMID: 32590986 BACKGROUND

MeSH Terms

Conditions

Severe Acute Malnutrition; Protein-Energy Malnutrition; Lactose Intolerance

Interventions

S-Adenosylmethionine

Condition Hierarchy (Ancestors)

Malnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Protein Deficiency; Deficiency Diseases; Malabsorption Syndromes; Intestinal Diseases; Gastrointestinal Diseases; Digestive System Diseases; Carbohydrate Metabolism, Inborn Errors; Metabolism, Inborn Errors; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Metabolic Diseases

Intervention Hierarchy (Ancestors)

Methionine; Amino Acids, Sulfur; Sulfur Compounds; Organic Chemicals; Adenosine; Purine Nucleosides; Purines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Amino Acids; Amino Acids, Peptides, and Proteins; Nucleosides; Nucleic Acids, Nucleotides, and Nucleosides; Ribonucleosides

Study Officials

• Muhammad T Sultan, PhD

  Bahauddin zakariya University,Multan

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Pricipal Investigator

Study Record Dates

• First Submitted: June 28, 2025
• First Posted: July 17, 2025
• Study Start: December 31, 2024
• Primary Completion: May 31, 2025
• Study Completion: May 31, 2025
• Last Updated: August 24, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will not share

Locations

PA (2)