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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:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| WHO standard f75 | Active Comparator | standard ,prepared.powdered F75 by WHO |
|
| Rice Based F75 | Experimental | Rice based F75 BY WHO recipe for PERSISTENT Diarhea |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| stool frequency | episodes of loose stools per day | day 1 to day 7 of starting therapeutic feed |
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| Measure | Description | Time Frame |
|---|---|---|
| hydration status | IMNCI Protocol | day 1 to day 7 of treatment |
| Re feeding syndrome | monitoring of vitals,edema,heart failure,electrolytes imbalance,convulsions |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Muhammad T Sultan, PhD | Bahauddin zakariya University,Multan | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Tehsil Head Quater Sujah Abad | Multan Khurd | Punjab Province | 60000 | Pakistan | ||
| The Childrens Hospital and Instotute of Child Health Multan |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 32590986 | Background | 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. |
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|
| 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. |
|
| Day 1 to day 7 of treatment with therapeutic feed |
| Electrolytes monitoring | - Serum Sodium and potassium Unit of Measure: mmol/L | Time Frame: Baseline and Day 4 |
| Multan Khurd |
| Punjab Province |
| 60000 |
| Pakistan |
| ID | Term |
|---|---|
| D000067011 | Severe Acute Malnutrition |
| D011502 | Protein-Energy Malnutrition |
| D007787 | Lactose Intolerance |
| ID | Term |
|---|---|
| D044342 | Malnutrition |
| D009748 | Nutrition Disorders |
| D009750 | Nutritional and Metabolic Diseases |
| D011488 | Protein Deficiency |
| D003677 | Deficiency Diseases |
| D008286 | Malabsorption Syndromes |
| D007410 | Intestinal Diseases |
| D005767 | Gastrointestinal Diseases |
| D004066 | Digestive System Diseases |
| D002239 | Carbohydrate Metabolism, Inborn Errors |
| D008661 | Metabolism, Inborn Errors |
| D030342 | Genetic Diseases, Inborn |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
| D008659 | Metabolic Diseases |
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| ID | Term |
|---|---|
| D012436 | S-Adenosylmethionine |
| ID | Term |
|---|---|
| D008715 | Methionine |
| D000603 | Amino Acids, Sulfur |
| D013457 | Sulfur Compounds |
| D009930 | Organic Chemicals |
| D000241 | Adenosine |
| D011684 | Purine Nucleosides |
| D011687 | Purines |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |
| D000596 | Amino Acids |
| D000602 | Amino Acids, Peptides, and Proteins |
| D009705 | Nucleosides |
| D009706 | Nucleic Acids, Nucleotides, and Nucleosides |
| D012263 | Ribonucleosides |
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