Lactose Intolerance in Infants With Gastrointestinal Disturbances

Ain Shams University

Status: Completed

Conditions: Lactose Intolerance

Treatments: Other: lactose free regimen

Study type: Interventional

Funder types: Other

Identifiers

NCT06789068

FMASU MS 742/ 2021

Details and patient eligibility

About

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.

Enrollment: 30 patients

Sex: All

Ages: 1 to 12 months old

Volunteers: No Healthy Volunteers

Inclusion criteria

• 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.

Exclusion criteria

• 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.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Sequential Assignment

Masking: None (Open label)

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30 participants in 1 patient group

Artificially fed infants

Experimental group

Description:

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.

Treatment:

Other: lactose free regimen