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Lactose Intolerance in Infants With Gastrointestinal Disturbances

Lactose Intolerance in Infants With Gastrointestinal Disturbances

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06789068
Enrollment
30
Registered
2025-01-23
Start date
2022-11-10
Completion date
2024-04-13
Last updated
2025-01-23

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Lactose Intolerance

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.

Interventions

OTHERlactose free regimen

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.

Sponsors

Ain Shams University
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
1 Months to 12 Months
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frameDescription
Frequency of infants with LI and mis diagnosed as a cow milk protein allergy.4 weeks interventionNumber of infants with LI with positive Cow's Milk-related Symptom Score (CoMiSS) (which could lead to misdiagnosis as CMPA)

Countries

Egypt

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026