NCT07242950Completed
Effect of Elimination Diet on Intestinal Mucus Barrier in Infants With Cow's Milk Protein Allergy
Evaluation of the Effect of Elimination Diet on Intestinal Mucus Barrier in Infants Diagnosed With Cow's Milk Protein Allergy
Source: ClinicalTrials.gov · Last updated 21 Nov 2025
Brief summary (registry, in English)
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.
- Status (registry)
- Completed
- Study type
- Observational
- Enrollment
- 34 (actual)
- First submitted
- 19 Sept 2025
- Start date
- 4 Sept 2023
- Primary completion date
- 4 Oct 2023
- Lead sponsor
- Baskent University
- NCT number
- NCT07242950
What you commit to
- Study type: Observational
- Participants enrolled: 34
- From 4 Sept 2023 to the primary completion date, 4 Oct 2023
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Who the study is looking for
- 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.
- The exclusion criteria for the case group are as follows:
- 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.
- The exclusion criteria for the control group are as follows:
- 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.
Age in the registry: 1 week to 26 weeks · Sex: All · Accepts healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Baskent University Coordinator of this site? Confirm its status | Ankara | Turkey (Türkiye) | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.