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.
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.
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.
- Conditions
- Cow Milk Allergy
- 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 group | Role | What they receive |
|---|---|---|
| EHCF + LGG | Experimental | Extensively hydrolyzed casein formula plus Lactobacillus rhamnosus GG Receives: Dietary Supplement: EHCF+LGG |
| RHF | Active comparator | Extensively hydrolyzed rice formula Receives: Dietary Supplement: RHF |
| EHWF | Active comparator | Extensively hydrolyzed protein formula Receives: Dietary Supplement: EHWF |
| AAF | Active comparator | Amino acid based formula Receives: Dietary Supplement: AAF |
| SF | Active comparator | Soy formula Receives: Dietary Supplement: SF |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
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
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
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
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
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
Concentration of metagenomic characteristics of the intestinal microbiota
evaluation of composition of gut microbiota
Measured: 12 months
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.
- First posted3 Dec 2019
- Study start10 Dec 2019
- Primary completion31 Dec 2023
- Study completion31 Aug 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cow Milk AllergyStudies of the same condition, open and under way.
- More trials run by Federico II UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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)
Sponsor and investigators
- Lead sponsor
- Federico II University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Roberto Berni Canani, MD, PhD, Federico II University
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
Study at a glance
From the registry record, last updated by the sponsor on 14 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Epigenetic Effects Involved in Children With Cow's Milk Allergy: A Possible Effect of Hypoallergenic Formulas
- ClinicalTrials.gov ID
- NCT04184700
- Acronym / sponsor ID
- EPICMA II / 28n15
- Conditions
- Cow Milk Allergy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 90 participants (actual)
- Lead sponsor
- Federico II UniversityUniversity, hospital or other
- Study start
- 10 Dec 2019 (actual)
- Primary completion
- 31 Dec 2023 (actual)
- Study completion
- 31 Aug 2024 (actual)
- First posted
- 3 Dec 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| EHCF + LGG | Experimental | Dietary Supplement: EHCF+LGGExtensively hydrolyzed casein formula plus Lactobacillus rhamnosus GG |
| RHF | Active comparator | Dietary Supplement: RHFExtensively hydrolyzed rice formula |
| EHWF | Active comparator | Dietary Supplement: EHWFExtensively hydrolyzed protein formula |
| AAF | Active comparator | Dietary Supplement: AAFAmino acid based formula |
| SF | Active comparator | Dietary Supplement: SFSoy formula |
Who may qualify
- Ages
- 6 to 12 months
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- children with cow's milk allergy
Key exclusion criteria (17 listed)
- Concomitant chronic systemic diseases,
- congenital cardiac defects,
- active tuberculosis,
- autoimmune diseases,
- immunodeficiency,
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| EHCF+LGGExtensively hydrolyzed casein formula containing Lactobacillus rhamnosus GG | Dietary supplement | EHCF + LGG |
| RHFRice hydrolysed formula | Dietary supplement | RHF |
| SFSoy formula | Dietary supplement | SF |
| EHWFextensively hydrolysed whey formula | Dietary supplement | EHWF |
| AAFamino acid based formula | Dietary supplement | AAF |
Primary outcome
Epigenetic modifications in cytokines genes
Time frame: 12 months
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).
7 secondary outcomes
Epigenetic modifications in cytokines genes
Time frame: 6 and 12 months
Epigenetic modifications in cytokines genes
Time frame: 6 and 12 months
Epigenetic modifications in cytokines genes
Time frame: 6 and 12 months
microRNAs modifications
Time frame: 12 months
The rate of patients with immune tolerance acquisition to cow's milk protein
Time frame: 12 months
Concentration of metagenomic characteristics of the intestinal microbiota
Time frame: 12 months
Concentration of metabolomic characteristics of the intestinal microbiota
Time frame: 12 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Apr 2026.
- Individual participant dataSharing planned: No
Related trials for Cow Milk Allergy
Active, not recruitingPhase 2
Phase 2b Study of RPT904 as Monotherapy in Participants With IgE-Mediated Food Allergy
Immune System Diseases, Ig-E Mediated Food Allergy
Recruiting
Evaluation of the Tolerance of a New Formula Based on Hydrolyzed Rice Proteins in Children With Cow's Milk Allergy
IgE-Mediated Cow Milk Allergy
Not yet recruiting
Performance of the Basophil Activation Test in the Diagnosis of IgE-mediated Cow's Milk Allergy in Infants and Evaluation of Hydrolysate Allergenicity.
Milk Allergy
Recruiting
Infant Formula in Infants and Children With Cow's Milk Allergy
Cow's Milk Allergy
RecruitingPhase 3
A 52-week Study of Remibrutinib in IgE-mediated Food Allergy
IgE-Mediated Food Allergy, Peanut Allergy
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
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.