Effects of different formulas on children with cow's milk allergy
Epigenetic Effects Involved in Children With Cow's Milk Allergy: A Possible Effect of Hypoallergenic Formulas
NA · Federico II University · NCT04184700
This study is testing whether adding Lactobacillus GG to different hypoallergenic formulas can help children with cow's milk allergy improve their immune response and develop tolerance to milk.
Quick facts
| Phase | NA |
|---|---|
| Study type | Interventional |
| Enrollment | 90 (estimated) |
| Ages | 6 Months to 12 Months |
| Sex | All |
| Sponsor | Federico II University (other) |
| Locations | 1 site (Naples) |
| Trial ID | NCT04184700 on ClinicalTrials.gov |
What this trial studies
This study investigates the impact of Lactobacillus GG (LGG) on children suffering from cow's milk allergy (CMA) by examining how different formulas can influence epigenetic changes and immune responses. The research aims to understand the immunoregulatory role of LGG in balancing cytokine production, which may play a crucial role in the development of tolerance to cow's milk. By analyzing the levels of specific cytokines associated with CMA, the study seeks to uncover the mechanisms behind tolerance acquisition in affected infants. The trial will involve various dietary interventions, including different hypoallergenic formulas supplemented with LGG.
Who should consider this trial
Good fit: Ideal candidates for this study are children diagnosed with cow's milk allergy.
Not a fit: Patients with concomitant chronic systemic diseases or other significant health issues may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved dietary interventions that help children with cow's milk allergy develop tolerance more effectively.
How similar studies have performed: Other studies have shown promising results with probiotics like LGG in managing atopic disorders, suggesting potential success for this approach.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * children with cow's milk allergy Exclusion Criteria: * Concomitant chronic systemic diseases, * congenital cardiac defects, * active tuberculosis, * autoimmune diseases, * immunodeficiency, * chronic inflammatory bowel diseases, * celiac disease, * cystic fibrosis, * metabolic diseases, * malignancy, * chronic pulmonary diseases, * malformations of the gastrointestinal tract, * suspected eosinophilic esophagitis or eosinophilic enterocolitis, * suspected food-protein-induced enterocolitis syndrome, * suspected cow's milk protein-induced anaphylaxis, * still on exclusion diet with one of the study formulas or with another dietary regimen because of cow's milk allergy, * other food allergies.
Where this trial is running
Naples
- Pediatric Office — Naples, Italy (RECRUITING)
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Cow Milk Allergy