An interventional study of WHO-recommended standard therapeutic milk used for stabilization phase in SAM) and HO-recommended Rice based therapeutic milk used for stabilization phase in SAM) in Severe Acute Malnutrition, Persistent Diarrhea and Children, sponsored by Children's Hospital and Institute of Child Health, Multan. Completed at 2 sites in Pakistan. Open to participants aged 6 Months to 59 Months. Per ClinicalTrials.gov, last updated 2025-08-24.
Sponsored by Children's Hospital and Institute of Child Health, Multan · Not applicable, Interventional, and Treatment
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:
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:
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.
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:
82 studies on the registry are indexed under Severe Acute Malnutrition; 13 are open to participants now.
This study's enrollment of 320 is below the median of 400 across 69 interventional studies indexed under Severe Acute Malnutrition.
Browse Severe Acute Malnutrition studies →Children's Hospital and Institute of Child Health, Multan is the lead sponsor of 9 studies on the registry; 2 are open to participants now.
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Exclusion Criteria:
standard ,prepared.powdered F75 by WHO
Dietary Supplement: WHO-recommended standard therapeutic milk used for stabilization phase in SAM)
Rice based F75 BY WHO recipe for PERSISTENT Diarhea
Dietary Supplement: HO-recommended Rice based 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.
Also known as: Stabalization phase feed
Rice based F75 GIVEN INITIALLY 2HOURLY,130 ml per kg than 3 and 4hourly maximum takes 5 to 7 days.
stool frequency
episodes of loose stools per day
Time frame: day 1 to day 7 of starting therapeutic feed
hydration status
IMNCI Protocol
Time frame: day 1 to day 7 of treatment
Re feeding syndrome
monitoring of vitals,edema,heart failure,electrolytes imbalance,convulsions
Time frame: Day 1 to day 7 of treatment with therapeutic feed
Electrolytes monitoring
\- Serum Sodium and potassium Unit of Measure: mmol/L
Time frame: Time Frame: Baseline and Day 4
Plan to share: No
This study is completed, as verified in Aug 2025. You cannot join it, but the record below documents what was studied.
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Children's Hospital and Institute of Child Health, Multan