Lactose Intolerance in Infants With Gastrointestinal Disturbances

NCT06789068 | Completed

• 1 other identifier: FMASU MS 742/ 2021
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

This study enrolled thirty infants who presented by GIT symptoms and their CoMiSS was ≥ 12. The patients were assessed upon presentation, after 2 weeks of receiving lactose free diet regimen and 2 weeks after rechallenging them with lactose. Assessments of infants included anthropometric measurements, CoMiSS estimation, Neonatal/Infant Pain Scale (NIPS) and pediatric quality of life assessment (Peds QL). The study aims to detect the frequency of infants with LI with positive Cow's Milk-related Symptom Score (CoMiSS) (which could lead to misdiagnosis as CMPA) and validate of this score to be used as a screening tool for LI in infants.

Conditions

Lactose Intolerance

Outcome Measures

Primary Outcomes (1)

• Frequency of infants with LI and mis diagnosed as a cow milk protein allergy.

  Number of infants with LI with positive Cow's Milk-related Symptom Score (CoMiSS) (which could lead to misdiagnosis as CMPA)

  4 weeks intervention

Study Arms (1)

Artificially fed infants

EXPERIMENTAL

Infants who presented by GIT symptoms and their Cow's Milk-related Symptom Score (CoMiSS) ≥ 12 who received lactose free diet regimen for 2 weeks then received then a regimen containing lactose, a tailored dietary plan was given to each participant, and it included lactose-containing formula and dairy based products like yogurt and cheese were included for infants over 6 months.

Other: lactose free regimen

Interventions

lactose free regimen OTHER

lactose free formula and solid foods that lack lactose for infants above 6 months, ensuring adequate macro and micronutrients intake according to recommended daily allowances (RDA) for age and sex.

Artificially fed infants

Eligibility Criteria

• Age: 1 Month - 12 Months
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• Artificially fed infants.
• Presented with GIT symptoms such as vomiting, diarrhea, abdominal pain, discomfort and distention.
• Cow's Milk-related Symptom Score (CoMiSS) of 12 or higher.

You may not qualify if:

• Infants with positive family history of Cow's milk protein allergy CMPA.
• Any allergic diseases.
• History of anaphylaxis.
• Atopic dermatitis, swelling of lips or eyelids, urticaria or wheezy chest.

Sponsors & Collaborators

• Ain Shams University: lead

Study Sites (1)

Ain Shams University

Cairo, Egypt

Location

MeSH Terms

Conditions

Lactose Intolerance

Condition Hierarchy (Ancestors)

Malabsorption Syndromes; Intestinal Diseases; Gastrointestinal Diseases; Digestive System Diseases; Carbohydrate Metabolism, Inborn Errors; Metabolism, Inborn Errors; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Metabolic Diseases; Nutritional and Metabolic Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: lecturer of pediatrics

Study Record Dates

• First Submitted: January 17, 2025
• First Posted: January 23, 2025
• Study Start: November 10, 2022
• Primary Completion: January 30, 2024
• Study Completion: April 13, 2024
• Last Updated: January 23, 2025

Record last verified: 2024-08

Locations

EG (1)