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Effect of Elimination Diet on Intestinal Mucus Barrier in Infants With Cow's Milk Protein Allergy

NCT07242950 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 34

Last updated 2025-11-21

No results posted yet for this study

Summary

The goal of this observational study is to learn about the effects of cow's milk protein elimination diets on breastfed infants under 26 weeks of age with newly diagnosed non-IgE-mediated CMPA. The main question it aims to answer is:

Does a cow's milk protein elimination diet improve clinical symptoms (CoMiSS scores), growth parameters, and gut immune markers (MUC2 and sIgA) in breastfed infants with CMPA?

Participants included breastfed infants under 26 weeks diagnosed with non-IgE-mediated CMPA and healthy age- and sex-matched controls without allergies. Infants and their mothers were followed prospectively. Data were collected at baseline and at the end of the study through face-to-face surveys with mothers, three-day food records, anthropometric measurements, CoMiSS evaluations, and stool samples. Mothers in the CMPA group received education on elimination diets, calcium supplementation, and complementary feeding guidance, while the control group received only complementary feeding guidance. Stool samples were analyzed for MUC2 and sIgA using ELISA.

Conditions

  • Cow Milk Protein Allergy
  • Mucin
  • Immunoglobulin A
  • Diet Therapy

Sponsors & Collaborators

  • Baskent University

    lead OTHER

Eligibility

Min Age
1 Week
Max Age
26 Weeks
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2023-09-04
Primary Completion
2023-10-04
Completion
2024-08-30

Countries

  • Turkey (Türkiye)

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07242950 on ClinicalTrials.gov