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Completed

NCT Number: NCT06789068

Lactose Intolerance in Infants With Gastrointestinal Disturbances

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.

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Key information

Conditions

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

Age range

1 month–12 month

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Ain Shams University

Cairo, Egypt

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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.

Primary outcomes

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

    Time frame: 4 weeks intervention

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

Sponsors and collaborators

Lead sponsor

Ain Shams University

Other

Registry information

Important dates

Study start
2022
Primary completion
2024
Study completion
2024
First posted
Jan 23, 2025
Registry last updated
Jan 23, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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