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

NCT07242950 | Completed DMC

• 1 other identifier: KA23/257
• Study Type: observational
• Target: 34
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

Cow Milk Protein Allergy; Mucin-2; Secretory Immunoglobulin A; Elimination Diet

Outcome Measures

Primary Outcomes (2)

• MUC2 level

  From the day of CMPA diagnosis in infants until three months later in case group From the beginning the study in infants until three months later in control group

• sIgA level

  From the day of CMPA diagnosis in infants until three months later in case group From the beginning the study in infants until three months later in control group

Secondary Outcomes (1)

• Monitoring of growth

  From the day of CMPA diagnosis in infants until three months later in case group From the beginning the study in infants until three months later in control group

Eligibility Criteria

• Age: 1 Week - 26 Weeks
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)
• Sampling Method: Probability Sample

Study Population

The study included breastfed babies under 26 weeks of age who were diagnosed with new non-IgE-mediated CMPA by an allergist, had an elimination diet, and applied to two hospitals designated in Türkiye. Infants and their mothers without allergies or atopic diseases, similar in age and gender, were in the control group.

You may qualify if:

• Diagnosed with non-IgE-mediated ARI during the study period,
• Aged less than 26 weeks at the beginning of the study,
• Still breastfeeding,
• Gestational age between 37 and 42 weeks,
• Single birth,
• Birth weight ≥ 2500 g and ≤ 4500 g, and their mothers.

You may not qualify if:

• those with a diagnosed chronic or systemic disease, those with neonatal disease or congenital malformation, those who have had an infection or illness requiring hospitalisation during the study period, infants who have never been breastfed and their mothers.
• Age less than 26 weeks at the beginning of the study,
• No allergy to food or medication,
• No diagnosis of an atopic disease,
• Still breastfeeding,
• Gestational age between 37 and 42 weeks,
• Single birth,
• Infants with birth weight ≥ 2500 g and ≤ 4500 g and their mothers.
• Those with a diagnosed allergy or atopic disease, those with a diagnosed known chronic or systemic disease, those with neonatal disease or congenital malformations, those who have experienced an infection or illness requiring hospitalisation during the study period, infants who have never received breast milk and their mothers.

Sponsors & Collaborators

• Baskent University: lead

Study Sites (1)

Baskent University

Ankara, Etimesgut, 06790, Turkey (Türkiye)

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

stool sample

MeSH Terms

Conditions

Medullary cystic kidney disease 1

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Target Duration: 3 Months
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 19, 2025
• First Posted: November 21, 2025
• Study Start: September 4, 2023
• Primary Completion: October 4, 2023
• Study Completion: August 30, 2024
• Last Updated: November 21, 2025

Record last verified: 2025-11

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, ICF, CSR
• Time Frame: Data requests can be submitted starting 9 months after article publication and the data will be made accessible for up to 24 months. Extensions will be considered on a case-by-case basis.
• Access Criteria: Exclusion Criteria: * Exclusion criteria for the case group: have a chronic or systemic disease, have a neonatal disease or congenital malformation, have had an infection or illness requiring hospitalisation during the research process, infants who have never received breast milk, and the mothers of these infants. Exclusion criteria for the control group: have a diagnosed allergy or atopic disease, have a diagnosed known chronic or systemic disease, have a neonatal disease or congenital malformation, those who have an infection or disease requiring hospitalisation during the study period, infants who have not received any breast milk, and the mothers of these infants.

Locations

TU (1)