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Search / Trial NCT04184700

Epigenetic Effects in Children With Cow's Milk Allergy Treated With Different Formulas

Launched by FEDERICO II UNIVERSITY · Nov 29, 2019

Trial Information

Current as of June 27, 2025

Recruiting

Keywords

ClinConnect Summary

This clinical trial is studying how a specific probiotic, Lactobacillus GG (LGG), affects children with cow's milk allergy. The researchers are particularly interested in understanding how LGG might help these children develop a tolerance to cow's milk, which means being able to consume it without having an allergic reaction. The trial is looking at the changes in the immune system and gene expression that occur when children are treated with a special formula containing LGG.

To participate in this trial, children must be between 6 months and 1 year old and diagnosed with cow's milk allergy. However, children with certain health conditions, such as autoimmune diseases or chronic inflammatory issues, cannot join. Participants will likely receive the Nutramigen LGG formula and be monitored for their progress over time. This trial aims to uncover important information that could lead to better treatments for children with cow's milk allergies, helping them live healthier, more normal lives.

Gender

ALL

Eligibility 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.

About Federico Ii University

Federico II University, located in Naples, Italy, is a prestigious academic institution with a strong emphasis on advanced research and clinical innovation. As a clinical trial sponsor, the university is committed to fostering the development of novel therapeutic interventions and enhancing patient care through rigorous scientific inquiry. With a multidisciplinary approach, Federico II University collaborates with healthcare professionals, researchers, and industry partners to conduct high-quality clinical trials that adhere to ethical standards and regulatory requirements. Its dedication to improving health outcomes is reflected in its robust research programs and commitment to translating scientific findings into clinical practice.

Locations

Naples, , Italy

Patients applied

0 patients applied

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported

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