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Cow Milk AllergyEPICMA IINCT04184700

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

A study testing EHCF+LGG, RHF and SF in people with Cow Milk Allergy, run by Federico II University at 1 site in Italy.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

Lactobacillus GG (LGG) is able to exert long lasting effects in children with atopic disorders. Nutramigen LGG accelerates tolerance acquisition in infants with cow's milk allergy. The mechanisms of these effects are still largely undefined. Read more about this study

Who is it for?
Ages 6 to 12 months
Conditions the study is for
Cow Milk Allergy
What is being tested?
EHCF+LGG, RHF and SF
Could I receive a placebo?
No, everyone receives an active treatment
How many people
90 participants
Where
1 siteItaly
Study dates
10 Dec 2019to 31 Aug 2024
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 6 to 12 months
  • All sexes
  • No healthy volunteers
  • Child

Who may be able to join

  • children with cow's milk allergy

Who cannot join

  • Concomitant chronic systemic diseases,
  • congenital cardiac defects,
  • active tuberculosis,
  • autoimmune diseases,
  • immunodeficiency,
  • chronic inflammatory bowel diseases,
Show all 17Show fewer
  • 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.

Trial locations and contacts

1 site in 1 country.

Italy1 site
  • Pediatric Office

    Naples, 80100

Other trials in Italy

About this study

Official title: Epigenetic Effects Involved in Children With Cow's Milk Allergy: A Possible Effect of Hypoallergenic Formulas

Lactobacillus GG (LGG) is able to exert long lasting effects in children with atopic disorders. Nutramigen LGG accelerates tolerance acquisition in infants with cow's milk allergy. The mechanisms of these effects are still largely undefined. The effect of LGG could be related at least in part by the immunoregulatory role played by LGG. This probiotic can balance the generation of cytokines possibly involved in IgE- or non-IgE-mediated cow's milk allergy Interleulkin (IL)-4, IL-5, IL-10, IFN-γ , TGF-β, and TNF-Υ), which can contribute to modulation of inflammatory processes. The investigators have demonstrated that children with IgE-mediated CMA produce significantly higher level of IL-4 and IL-13 in response to cow's milk protein, and that tolerance is associated with a marked reduction of IL-13 production and a concomitant increased frequency of IFN-γ releasing cells. Epigenetics studies the heritable (and potentially reversible) changes of the genome inherited from one cell generation to the next which alter gene expression but do not involve changes in primary DNA sequences, highlighting the complexity of the inter-relationship between genetics and nutrition. There are three distinct, but closely interacting, epigenetic mechanisms (histone acetylation, DNA methylation, and non-coding microRNAs) that are responsible for modifying the expression of critical genes associated with physiologic and pathologic processes. The profile of epigenetic modifications associated with Th lineage commitment, coupled with the sensitivity of the early developmental period, has led to speculation that factors that disrupt these pathways may increase the risk of allergic diseases. Specifically, effects on DNA methylation and endogenous histone deacetylase inhibitors acting on specific pathways (Th1 and T regulatory cell differentiation) may favour Th2-associated allergic differentiation. MicroRNAs are another structural components of an epigenetic mechanism of post-transcriptional regulation of messenger RNA translation. It has been recently identified a specific Th2-associated microRNA (miR-21) that is critical for the regulation of Th cell polarization. It has been previously demonstrated an inverse DNA methylation pattern of cytokines involved in Th2 response (IL-4, IL-5) compared with cytokines involved in Th1 response (IL-10, INF- y) in children with CMA acquiring oral tolerance, with the most pronounced effects in those treated with Nutramigen LGG.

Being tested
EHCF+LGG, RHF, SF, EHWF, AAF
Medical subject headings
Milk Hypersensitivity

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • EHCF+LGGDietary supplement

    Extensively hydrolyzed casein formula containing Lactobacillus rhamnosus GG

  • RHFDietary supplement

    Rice hydrolysed formula

  • SFDietary supplement

    Soy formula

  • EHWFDietary supplement

    extensively hydrolysed whey formula

  • AAFDietary supplement

    amino acid based formula

Study groups in NCT04184700
Study groupRoleWhat they receive
EHCF + LGGExperimentalExtensively hydrolyzed casein formula plus Lactobacillus rhamnosus GG
Receives: Dietary Supplement: EHCF+LGG
RHFActive comparatorExtensively hydrolyzed rice formula
Receives: Dietary Supplement: RHF
EHWFActive comparatorExtensively hydrolyzed protein formula
Receives: Dietary Supplement: EHWF
AAFActive comparatorAmino acid based formula
Receives: Dietary Supplement: AAF
SFActive comparatorSoy formula
Receives: Dietary Supplement: SF

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Epigenetic modifications in cytokines genes

    TSDR demethylation (prop.) of FOXP3 in children with cow's milk allergy. The primary outcome was the time-averaged FoxP3 Treg-Specific-Demethylation-Region (TSDR) demethylation (prop.), which took into account three repeated measures (0,6,12 months).

    Measured: 12 months

Secondary outcomes (7)
  1. Epigenetic modifications in cytokines genes

    Demethtylation rate and expression (fc, fold change, ΔΔCt method)) of FOXP3 in children with cow's milk allergy

    Measured: 6 and 12 months

  2. Epigenetic modifications in cytokines genes

    Methylation rate (%) of interleukin IL-4, IL-5, IL-10, IFN-γ, in children with cow's milk allergy

    Measured: 6 and 12 months

  3. Epigenetic modifications in cytokines genes

    Serum levels (pg/ml) of interleukin IL-4, IL-5, IL-10, IFN-γ in children with cow's milk allergy

    Measured: 6 and 12 months

  4. microRNAs modifications

    Expression of miR-125b miR-146a miR-155 miR-29a/b miR-27a miR-128 miR-21 miR-126 miR-145 miR-106a miR-193a5p miR-128

    Measured: 12 months

  5. The rate of patients with immune tolerance acquisition to cow's milk protein

    Rate of patients with acquisition of tolerance to cow milk protein (rate of patients with outgrown cow's milk allergy)

    Measured: 12 months

  6. Concentration of metagenomic characteristics of the intestinal microbiota

    evaluation of composition of gut microbiota

    Measured: 12 months

  7. Concentration of metabolomic characteristics of the intestinal microbiota

    evaluation of function of gut microbiota

    Measured: 12 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted3 Dec 2019
  2. Study start10 Dec 2019
  3. Primary completion31 Dec 2023
  4. Study completion31 Aug 2024

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Double blind
Who is masked
Investigator, Outcomes assessor
Enrolment
90 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04184700
Sponsor's protocol ID
28n15
Acronym
EPICMA II
Status last verified
Dec 2025
First submitted
29 Nov 2019
Last updated
14 Apr 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A study testing EHCF+LGG, RHF and SF in people with Cow Milk Allergy, run by Federico II University at 1 site in Italy.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 1 inclusion and 17 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 14 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Epigenetic modifications in cytokines genes (time frame: 12 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Apr 2026.

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