Dietary Management of Well Nourished Children With Persistent Diarrhea and Secondary Lactose Intolerance With Different Feeding Formulas.( Hospital-Originated Modified Feeding HOMF)
NCT ID: NCT07114796
Last Updated: 2025-08-24
Study Results
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Basic Information
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COMPLETED
NA
320 participants
INTERVENTIONAL
2025-01-01
2025-06-30
Brief Summary
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Detailed Description
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Persistent diarrhea is defined as the passage of three or more abnormally loose or liquid stools per day, lasting more than 14 days, in the absence of other chronic gastrointestinal diseases. Secondary lactose intolerance is confirmed based on clinical presentation and stool findings such as acidic pH (\<5.5) and positive reducing substances, typically resulting from post-infectious damage to the intestinal brush border where lactase activity resides.
The protocol consists of two parallel intervention arms:
Arm A (Formula-based group): Participants receive commercially available lactose-free pediatric formulas (LFFs) such as soy-based or hydrolyzed protein formulas, prepared as per manufacturer instructions. These formulas are age-appropriate, meet the caloric needs (\~80-100 kcal/kg/day), and are devoid of lactose.
Arm B (Recipe-based group): Participants are administered locally-prepared therapeutic recipes standardized in the ward kitchen. Recipes include lactose-free rice milk, along with mung dal khichdi, and chicken broth-based porridges, designed for low osmolarity (\<200 mOsm/L), high digestibility, and acceptable protein content. Recipes are prepared fresh daily under sterile conditions using pre-approved kitchen protocols and nutrient calculations.
All enrolled children are initially assessed for hydration status, weight, dietary history, and clinical signs of lactose intolerance. Baseline laboratory parameters (CBC, stool pH, reducing substances, electrolytes) are recorded. After informed consent, participants are randomized to either of the two intervention arms using block randomization (1:1 ratio), stratified by age and sex.
The feeding protocol is administered for 7-14 days, depending on clinical recovery and stool normalization. Feeding quantities are tailored based on caloric needs and tolerated volume, starting from 130 ml/kg/day and adjusted as per WHO guidelines for nutritional management in diarrhea. Monitoring includes daily stool frequency and consistency, weight changes, hydration status, adverse events, and acceptability of the diet (assessed by a 5-point hedonic scale).
Clinical improvement is defined as resolution of diarrhea (less than three loose stools per day), negative stool reducing substances, and normalization of stool pH (\>6). If no improvement is observed by Day 5, re-evaluation is performed, and switching of the feeding strategy is considered only after safety clearance.
The study also explores the cost-effectiveness, caregiver acceptability, and preference patterns between the two approaches. Special attention is given to the preparation feasibility of the recipes in a home setting post-discharge, thereby promoting sustainability and local adaptability of therapeutic feeds in resource-limited environments.
All protocols follow ethical standards as per the Declaration of Helsinki and institutional IRB approval. The study is registered on a national trial registry. Data confidentiality is maintained using encrypted electronic records, and adverse events are reported in compliance with regulatory standards.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
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COMMERCIAL LACTOSE FREE FORMULAS.
feeding formula commercially available on 100 kcal per kg given ,1-1 dilution as per demand
Standard Commercial Lactose-Free Formula
"COMMERCIAL LACTOSE FREE FORMULAS" Intervention Type: Dietary Supplement or Nutritional Intervention
Name of Intervention: Standard Commercial Lactose-Free Formula
Description: A commercially available lactose-free formula (e.g., Isomil, Alfamino, or equivalent), used for feeding children during the stabilization phase of persistent diarrhea treatment.
Route: Oral/Nasogastric
Dosage: 130 ml/kg/day as per WHO schedule
Duration: 7 days
Rice based recipe method feeding formula .
rice based recipe method feed prepared at ward with rice oil,30 ml skimmed milk and sugar , given total of 100 kcal per kg of child on demand along rice based complementary feeding,
Rice based recipe method feeding formula
Rice based recipe method feeding formula" Intervention Type: Dietary Supplement or Nutritional Intervention
Name of Intervention: Rice-Based Lactose-Free Therapeutic Formula
Description: A locally prepared rice-based formula developed as an alternative to F-75, using puffed rice, sugar, oil, and micronutrient mix. It is lactose-free and used for feeding well-nourished children with persistent diarrhea.
Route: Oral/Nasogastric
Dosage: As per WHO feeding schedule - 130 ml/kg/day in 2-hourly feeds.
Duration: 7 days during the stabilization phase
For Arm: "COMMERCIAL LACTOSE FREE FORMULAS" Intervention Type: Dietary Supplement or Nutritional Intervention
Name of Intervention: Standard Commercial Lactose-Free Formula
Description: A commercially available lactose-free formula (e.g., Isomil, Alfamino, or equivalent), used for feeding children during the stabilization phase of persistent diarrhea treatment.
Route: Oral/Nasogastric
Dosage: 130 ml/kg/day as per WHO schedule
Duration:
Interventions
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Standard Commercial Lactose-Free Formula
"COMMERCIAL LACTOSE FREE FORMULAS" Intervention Type: Dietary Supplement or Nutritional Intervention
Name of Intervention: Standard Commercial Lactose-Free Formula
Description: A commercially available lactose-free formula (e.g., Isomil, Alfamino, or equivalent), used for feeding children during the stabilization phase of persistent diarrhea treatment.
Route: Oral/Nasogastric
Dosage: 130 ml/kg/day as per WHO schedule
Duration: 7 days
Rice based recipe method feeding formula
Rice based recipe method feeding formula" Intervention Type: Dietary Supplement or Nutritional Intervention
Name of Intervention: Rice-Based Lactose-Free Therapeutic Formula
Description: A locally prepared rice-based formula developed as an alternative to F-75, using puffed rice, sugar, oil, and micronutrient mix. It is lactose-free and used for feeding well-nourished children with persistent diarrhea.
Route: Oral/Nasogastric
Dosage: As per WHO feeding schedule - 130 ml/kg/day in 2-hourly feeds.
Duration: 7 days during the stabilization phase
For Arm: "COMMERCIAL LACTOSE FREE FORMULAS" Intervention Type: Dietary Supplement or Nutritional Intervention
Name of Intervention: Standard Commercial Lactose-Free Formula
Description: A commercially available lactose-free formula (e.g., Isomil, Alfamino, or equivalent), used for feeding children during the stabilization phase of persistent diarrhea treatment.
Route: Oral/Nasogastric
Dosage: 130 ml/kg/day as per WHO schedule
Duration:
Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
6 Months
59 Months
ALL
No
Sponsors
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Children's Hospital and Institute of Child Health, Multan
OTHER_GOV
Responsible Party
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Dr. Saadia Khan
principal investigator
Principal Investigators
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Muhammad T Sultan, Phd
Role: STUDY_CHAIR
Bahuddin Zakariya University,Multan.
Locations
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Children's Hospital and Institute of child health Multan
Multan, Punjab Province, Pakistan
Tehsil Head Quater Sujah Abad
Multan Khurd, Punjab Province, Pakistan
Countries
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Related Links
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This expert-consensus review (with clinical growth evidence) supports the use of hydrolyzed rice formulas as a first-line alternative to cow's milk-based eHF or AAF, showing adequate growth and high tolerability in infants (including well-nourished ones)
Other Identifiers
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U1111-1326-2819
Identifier Type: -
Identifier Source: org_study_id
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