Dietary Management of Well Nourished Children With Persistent Diarrhea and Secondary Lactose Intolerance With Different Feeding Formulas.( Hospital-Originated Modified Feeding HOMF) (HOMF)

Nutritional Rehabilitation of Well Nourished Children With Persistent Diarrhea and Secondary Lactose Intolerance Using Rice Based Recipes Versus Already Prescribed Lactose Free Formulas .

Interventional, treatment based study randomized control trial 32O Well nourished children allocated in 2 groups 160 each group ,Group A on lactose free commercial formula already in use,Group B ,ON Rice based feeding recipe .

Study Overview

• Status: Completed
• Conditions: Ell-nourished Pediatric Patients; Nutritional Management in Diarrhea
• Intervention / Treatment: Dietary supplement: Standard Commercial Lactose-Free Formula; Dietary supplement: Rice based recipe method feeding formula

Detailed Description

his clinical protocol is designed to evaluate and compare the effectiveness, safety, and acceptability of different feeding interventions in well-nourished pediatric patients diagnosed with persistent diarrhea (PD) complicated by secondary lactose intolerance (SLI). The study involves the administration of both commercial lactose-free formulas and hospital-originated, modified feeding recipes (HOMF), including rice-based porridge and protein-rich preparations, over a structured treatment duration.

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.

• Study Type: Interventional
• Enrollment (Actual): 320
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Pakistan
  • Punjab
    • Multan, Punjab, Pakistan, 60000
      • Children's Hospital and Institute of child health Multan
    • Multān, Punjab, Pakistan, 60000
      • Tehsil Head Quater Sujah Abad

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• All children admitted to hospital with persistent diarrhea and secondary lactose intolerance

Exclusion Criteria:

• less than 6months primary lactose intolerance critically ill children

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: COMMERCIAL LACTOSE FREE FORMULAS.; feeding formula commercially available on 100 kcal per kg given ,1-1 dilution as per demand	Dietary supplement: 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
Experimental: 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,	Dietary supplement: 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:

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
stool frequency	episodes of loose stool per day	day 1 to day 7 of feed

Collaborators and Investigators

• Sponsor: Children's Hospital and Institute of Child Health, Multan
• Investigators: Study Chair: Muhammad T Sultan, Phd, Bahuddin Zakariya University,Multan.

Publications and helpful links

Helpful Links

• 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)

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2025
• Primary Completion (Actual): June 1, 2025
• Study Completion (Actual): June 30, 2025

Study Registration Dates

• First Submitted: August 4, 2025
• First Submitted That Met QC Criteria: August 4, 2025
• First Posted (Actual): August 11, 2025

Study Record Updates

• Last Update Posted (Actual): August 24, 2025
• Last Update Submitted That Met QC Criteria: August 22, 2025
• Last Verified: August 1, 2025

More Information

Terms related to this study

• Keywords: Persistent Diarrhea; Secondary Lactose Intolerance; Well-Nourished Children
• Additional Relevant MeSH Terms: Metabolism, Inborn Errors; Genetic Diseases, Inborn; Metabolic Diseases; Signs and Symptoms, Digestive; Intestinal Diseases; Digestive System Diseases; Gastrointestinal Diseases; Malabsorption Syndromes; Carbohydrate Metabolism, Inborn Errors; Diarrhea; Lactose Intolerance
• Other Study ID Numbers: U1111-1326-2819

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No