CompletedNot Applicable

Lactose Intolerance in Infants With Gastrointestinal Disturbances

Egypt30 participantsStarted 2022-11-10

Plain-language 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.

Who can participate

Age range1 Month – 12 Months

SexALL

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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.

What they're measuring

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

Timeframe: 4 weeks intervention

Trial details

NCT IDNCT06789068

SponsorAin Shams University

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2024-01-30

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