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

NCT ID: NCT07070856

Last Updated: 2025-08-24

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 320 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-12-31
• Study Completion Date: 2025-05-31

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.

Conditions

Severe Acute Malnutrition; Persistent Diarrhea; Children

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

WHO standard f75

standard ,prepared.powdered F75 by WHO

Group Type: ACTIVE_COMPARATOR

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

Intervention Type: DIETARY_SUPPLEMENT

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

Rice Based F75

Rice based F75 BY WHO recipe for PERSISTENT Diarhea

Group Type: EXPERIMENTAL

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

Intervention Type: DIETARY_SUPPLEMENT

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

Interventions

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.

Intervention Type: 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.

Intervention Type: DIETARY_SUPPLEMENT

Other Intervention Names

Stabalization phase feed

Eligibility Criteria

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 .

• Minimum Eligible Age: 6 Months
• Maximum Eligible Age: 59 Months
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Children's Hospital and Institute of Child Health, Multan

OTHER_GOV

Sponsor Role: lead

Responsible Party

Dr. Saadia Khan

Pricipal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Muhammad T Sultan, PhD

Role: STUDY_CHAIR

Bahauddin zakariya University,Multan

Locations

Tehsil Head Quater Sujah Abad

Multan Khurd, Punjab Province, Pakistan

The Childrens Hospital and Instotute of Child Health Multan

Multan Khurd, Punjab Province, Pakistan

Countries

Pakistan

References

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.

Reference Type: BACKGROUND

PMID: 32590986 (View on PubMed)

Other Identifiers

U1111-1324-6540

Identifier Type: -

Identifier Source: org_study_id