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

Children's Hospital and Institute of Child Health, Multan

Status: Completed

Conditions: Ell-nourished Pediatric Patients; Nutritional Management in Diarrhea

Treatments: Dietary Supplement: Rice based recipe method feeding formula; Dietary Supplement: Standard Commercial Lactose-Free Formula

Study type: Interventional

Funder types: Other

Identifiers

NCT07114796

U1111-1326-2819

Details and patient eligibility

About

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 .

Full 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.

Enrollment: 320 patients

Sex: All

Ages: 6 to 59 months old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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320 participants in 2 patient groups

COMMERCIAL LACTOSE FREE FORMULAS.

Active Comparator group

Description:

feeding formula commercially available on 100 kcal per kg given ,1-1 dilution as per demand

Treatment:

Dietary Supplement: Standard Commercial Lactose-Free Formula

Rice based recipe method feeding formula .

Experimental group

Description:

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,

Treatment:

Dietary Supplement: Rice based recipe method feeding formula