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

NCT07114796 | Completed

• 1 other identifier: U1111-1326-2819
• Study Type: interventional
• Target: 320
• Locations: 1 country
• Sites: 2

Brief Summary

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 .

Conditions

Ell-nourished Pediatric Patients; Nutritional Management in Diarrhea

Keywords

Persistent Diarrhea; Secondary Lactose Intolerance; Well-Nourished Children

Outcome Measures

Primary Outcomes (1)

• stool frequency

  episodes of loose stool per day

  day 1 to day 7 of feed

Study Arms (2)

COMMERCIAL LACTOSE FREE FORMULAS.

ACTIVE COMPARATOR

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

Dietary Supplement: Standard Commercial Lactose-Free Formula

Rice based recipe method feeding formula .

EXPERIMENTAL

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

Interventions

Standard Commercial Lactose-Free Formula DIETARY_SUPPLEMENT

"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

COMMERCIAL LACTOSE FREE FORMULAS.

Rice based recipe method feeding formula DIETARY_SUPPLEMENT

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:

Rice based recipe method feeding formula .

Eligibility Criteria

• Age: 6 Months - 59 Months
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

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

You may not qualify if:

• less than 6months primary lactose intolerance critically ill children

Sponsors & Collaborators

• Children's Hospital and Institute of Child Health, Multan: lead

Study Sites (2)

Children's Hospital and Institute of child health Multan

Multan, Punjab Province, 60000, Pakistan

Location

Tehsil Head Quater Sujah Abad

Multan Khurd, Punjab Province, 60000, Pakistan

Location

Related 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 Officials

• Muhammad T Sultan, Phd

  Bahuddin Zakariya University,Multan.

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: principal investigator

Study Record Dates

• First Submitted: August 4, 2025
• First Posted: August 11, 2025
• Study Start: January 1, 2025
• Primary Completion: June 1, 2025
• Study Completion: June 30, 2025
• Last Updated: August 24, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will not share

Locations

PA (2)