Epigenetic Effects in Children With Cow's Milk Allergy Treated With Different Formulas (EPICMA II)
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ClinicalTrials.gov Identifier: NCT04184700 |
Recruitment Status : Unknown
Verified November 2019 by Roberto Berni Canani, Federico II University.
Recruitment status was: Not yet recruiting
First Posted : December 3, 2019
Last Update Posted : December 3, 2019
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Cow Milk Allergy | Dietary Supplement: EHCF+LGG | Not Applicable |
Study Type : | Interventional (Clinical Trial) |
Estimated Enrollment : | 72 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | Double (Investigator, Outcomes Assessor) |
Primary Purpose: | Treatment |
Official Title: | Epigenetic Effects Involved in Children With Cow's Milk Allergy: A Possible Effect of Hypoallergenic Formulas |
Estimated Study Start Date : | December 10, 2019 |
Estimated Primary Completion Date : | December 31, 2020 |
Estimated Study Completion Date : | December 31, 2021 |
Arm | Intervention/treatment |
---|---|
Experimental: EHCF + LGG
Extensively hydrolyzed casein formula plus Lactobacillus rhamnosus GG
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Dietary Supplement: EHCF+LGG
Extensively hydrolyzed casein formula containing Lactobacillus rhamnosus GG |
Active Comparator: RHF
Extensively hydrolyzed rice formula
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Dietary Supplement: EHCF+LGG
Extensively hydrolyzed casein formula containing Lactobacillus rhamnosus GG |
Active Comparator: EHWF
Extensively hydrolyzed protein formula
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Dietary Supplement: EHCF+LGG
Extensively hydrolyzed casein formula containing Lactobacillus rhamnosus GG |
Active Comparator: AAF
Amino acid based formula
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Dietary Supplement: EHCF+LGG
Extensively hydrolyzed casein formula containing Lactobacillus rhamnosus GG |
- Epigenetic modifications in cytokines genes [ Time Frame: 12 months ]Serum levels (pg/ml) of interleukin 4, interleukin 5, interleukin 10, interferon gamma, FOXP3 in children with cow's milk allergy
- Epigenetic modifications in cytokines genes [ Time Frame: 12 months ]Methylation rate (%) of interleukin 4, interleukin 5, interleukin 10, interferon gamma, FOXP3 in children with cow's milk allergy
- microRNAs modifications [ Time Frame: 12 months ]Expression of miR106a, miR126, miR21, miR145, miR27a, miR29a/b, miR155, miR146a, miR128

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Ages Eligible for Study: | 6 Months to 12 Months (Child) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
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.

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04184700
Italy | |
Pediatric Office | |
Naples, Italy, 80100 | |
Contact: Roberto Berni Canani, MD, Ph 00390817462680 berni@unina.it |
Responsible Party: | Roberto Berni Canani, Associate professor, Federico II University |
ClinicalTrials.gov Identifier: | NCT04184700 |
Other Study ID Numbers: |
28n15 |
First Posted: | December 3, 2019 Key Record Dates |
Last Update Posted: | December 3, 2019 |
Last Verified: | November 2019 |
Individual Participant Data (IPD) Sharing Statement: | |
Plan to Share IPD: | No |
Studies a U.S. FDA-regulated Drug Product: | No |
Studies a U.S. FDA-regulated Device Product: | No |
Hypersensitivity Milk Hypersensitivity Immune System Diseases Food Hypersensitivity Hypersensitivity, Immediate |