Food AllergiesALLERGYSTOPNCT06751810
Nutritional Status in Children With Food Allergy: Evaluation of a New Supplement
A study testing Food supplement in people with Food Allergies, run by Federico II University at 1 site in Italy.
Trial summary
Allergic diseases are rising globally. By 2025, over half of the European population is projected to be affected by some form of allergy, with the highest rates among infants and young children. Read more about this study
- Who is it for?
- Ages 36 to 60 months
- Conditions the study is for
- Food Allergies
- What is being tested?
- Food supplement
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 30 participants
- Where
- 1 siteItaly
- Study dates
- 30 Dec 2024to 31 Oct 2025
- 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 36 to 60 months
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- subjects with food allergy
- Gestational age ≥ 37 weeks
- Stable clinical condition and free from any symptoms possibly related to food allergy at least four weeks prior to study enrollment
- Observing a strict cow's milk elimination diet for at least 4 weeks prior to study enrollment and until the completion of the study
- Parent(s) or legal guardian agrees not to enroll infant or child in another interventional clinical study while participating in this study
- Written informed consent obtained from at least one parent (or legally acceptable representative [LAR], if applicable)
- Infant or child's parent(s) / LAR is of legal age of majority, must have parental authority, must understand the informed consent form and other study documents, and are willing and able to fulfill the requirements of the study protocol
Who cannot join
- other concomitant diseases
- Infant or child's parent has other medical or psychiatric condition that, in the judgement of the Investigator, would make the infant or child inappropriate for entry into the study.
- Currently participating or having participated in another interventional clinical study within 4 weeks prior to enrollment.
Trial locations and contacts
1 site in 1 country.
Italy1 site
Department of Traslational Medical Science - University of Naples Federico II
Naples, Naples, 80131
About this study
Official title: EVALUATION OF A NEW SUPPLEMENT ON NUTRITIONAL STATUS IN CHILDREN WITH FOOD ALLERGY
Allergic diseases are rising globally. By 2025, over half of the European population is projected to be affected by some form of allergy, with the highest rates among infants and young children. This growing prevalence also has a significant economic impact, resulting in more than 100 million lost work and school days each year due to allergic conditions.
Allergies arise from a breakdown in immune tolerance mechanisms. Current research suggests that the development is influenced by genetic, environmental, and gene-environment interactions, leading to immune system dysfunction, partly mediated by epigenetic mechanisms. Various factors have been proposed as contributors to FA onset. Among the unchangeable risk factors are male sex, race/ethnicity (with higher risks among Asian and Black children compared to White children), and genetics (familial associations, HLA, and specific genes).
Read more
Modifiable risk factors also play a role, with growing evidence showing that environmental influences, such as the use of antibiotics, antiseptic agents, and a high-fat, low-fiber diet, negatively affect microbiome composition. Additional risk factors potentially affecting FA onset include atopic diseases (such as comorbid atopic dermatitis), increased hygiene, vitamin D deficiency, reduced consumption of omega-3 polyunsaturated fatty acids and antioxidants, the use of antacids (which hinder the digestion of allergens), obesity, and the timing and route of food exposure (increased risk with delayed oral ingestion of allergens coupled with environmental exposure). The microbiome also plays a critical role in these processes.
Currently, no Food and Drug Administration (FDA)-approved treatment exists for FA, and the standard approach is strict dietary avoidance of the triggering allergens. As a result, the nutritional burden of elimination diets can be substantial, leading to risks such as growth failure, micronutrient deficiencies, and feeding challenges with long-term consequences.
- Conditions
- Food Allergies
- Being tested
- Food supplement, Placebo
- Keywords
- allergy, food allergy, cow milk protein allergy
- Medical subject headings
- Food Hypersensitivity, Hypersensitivity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Food supplementDietary supplement
The nutritional composition of the food supplement comprises:
sodium butyrate, inactivated Lactobacillus rhamnosus GG Perilla frutescens dry extract quercetin fructo-oligosaccharides Vitamin D3 omega 3 polyunsaturated acids
PlaceboOther
Placebo
| Study group | Role | What they receive |
|---|---|---|
| Supplement | Experimental | Subjects assigned to receive the treatment Receives: Dietary Supplement: Food supplement |
| Placebo | Placebo comparator | Subjects assigned to receive the placebo Receives: Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
body growth parameters
body mass index
Measured: after 6 months of treatment
Secondary outcomes (5)
biochemical values
serum vitamin D levels
Measured: after 6 months of treatment
biochemical values
serum DHA levels
Measured: after 6 months of treatment
Cytokines production
Th2 cytokines (IL-4, IL-5, IL-13), IL-10 production
Measured: after 48 days
regulatory T cells (Tregs) production
regulatory T cells (Tregs)
Measured: after 4 days
regulatory dendritic cell markers production
regulatory dendritic cell markers (Tgfb1, Ifna2, Ptgs2, Csf2)
Measured: after 4 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Dec 2024
- Study start30 Dec 2024
- Primary completion30 Sep 2025
- Study completion31 Oct 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Food AllergiesStudies 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
- Triple blind
- Who is masked
- Participant, Care provider, Outcomes assessor
- Enrolment
- 30 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
- NCT06751810
- Sponsor's protocol ID
- 09/24
- Acronym
- ALLERGYSTOP
- Status last verified
- Dec 2024
- First submitted
- 15 Dec 2024
- Last updated
- 17 Dec 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Carucci L, Caldaria E, Oglio F, Iorio RF, Mauriello V, Masino A, Coppola S. Immunonutritional effects elicited by a novel multicomponent food supplement in children with cow's milk allergy: results from a randomized, placebo-controlled trial. Front Allergy. 2026 Mar 16;7:1760231. doi: 10.3389/falgy.2026.1760231. eCollection 2026.
PubMed 41918962
Study at a glance
From the registry record, last updated by the sponsor on 17 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- EVALUATION OF A NEW SUPPLEMENT ON NUTRITIONAL STATUS IN CHILDREN WITH FOOD ALLERGY
- ClinicalTrials.gov ID
- NCT06751810
- Acronym / sponsor ID
- ALLERGYSTOP / 09/24
- Conditions
- Food Allergies
- Keywords
- allergy, food allergy, cow milk protein allergy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Federico II UniversityUniversity, hospital or other
- Study start
- 30 Dec 2024 (actual)
- Primary completion
- 30 Sep 2025 (actual)
- Study completion
- 31 Oct 2025 (actual)
- First posted
- 30 Dec 2024 (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.
Allergic diseases are rising globally. By 2025, over half of the European population is projected to be affected by some form of allergy, with the highest rates among infants and young children. This growing prevalence also has a significant economic impact, resulting in more than 100 million lost work and school days each year due to allergic conditions.
Allergies arise from a breakdown in immune tolerance mechanisms. Current research suggests that the development is influenced by genetic, environmental, and gene-environment interactions, leading to immune system dysfunction, partly mediated by epigenetic mechanisms. Various factors have been proposed as contributors to FA onset. Among the unchangeable risk factors are male sex, race/ethnicity (with higher risks among Asian and Black children compared to White children), and genetics (familial associations, HLA, and specific genes).
Modifiable risk factors also play a role, with growing evidence showing that environmental influences, such as the use of antibiotics, antiseptic agents, and a high-fat, low-fiber diet, negatively affect microbiome composition. Additional risk factors potentially affecting FA onset include atopic diseases (such as comorbid atopic dermatitis), increased hygiene, vitamin D deficiency, reduced consumption of omega-3 polyunsaturated fatty acids and antioxidants, the use of antacids (which hinder the digestion of allergens), obesity, and the timing and route of food exposure (increased risk with delayed oral ingestion of allergens coupled with environmental exposure). The microbiome also plays a critical role in these processes.
Currently, no Food and Drug Administration (FDA)-approved treatment exists for FA, and the standard approach is strict dietary avoidance of the triggering allergens. As a result, the nutritional burden of elimination diets can be substantial, leading to risks such as growth failure, micronutrient deficiencies, and feeding challenges with long-term consequences.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Supplement | Experimental | Dietary Supplement: Food supplementSubjects assigned to receive the treatment |
| Placebo | Placebo comparator | Other: PlaceboSubjects assigned to receive the placebo |
Who may qualify
- Ages
- 36 to 60 months
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (7 listed)
- subjects with food allergy
- Gestational age ≥ 37 weeks
Key exclusion criteria (3 listed)
- other concomitant diseases
- Infant or child's parent has other medical or psychiatric condition that, in the judgement of the Investigator, would make the infant or child inappropriate for entry into the study.
- Currently participating or having participated in another interventional clinical study within 4 weeks prior to enrollment.
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 |
|---|---|---|
| Food supplementThe nutritional composition of the food supplement comprises: sodium butyrate, inactivated Lactobacillus rhamnosus GG Perilla frutescens dry extract quercetin fructo-oligosaccharides Vitamin D3 omega 3 polyunsaturated acids | Dietary supplement | Supplement |
| PlaceboPlacebo | Other | Placebo |
Primary outcome
body growth parameters
Time frame: after 6 months of treatment
body mass index
5 secondary outcomes
biochemical values
Time frame: after 6 months of treatment
biochemical values
Time frame: after 6 months of treatment
Cytokines production
Time frame: after 48 days
regulatory T cells (Tregs) production
Time frame: after 4 days
regulatory dendritic cell markers production
Time frame: after 4 days
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 17 Dec 2025.
- Derived from this study: PubMed 41918962Carucci L, Caldaria E, Oglio F, Iorio RF, Mauriello V, Masino A, Coppola S. Immunonutritional effects elicited by a novel multicomponent food supplement in children with cow's milk allergy: results from a randomized, placebo-controlled trial. Front Allergy. 2026 Mar 16;7:1760231. doi: 10.3389/falgy.2026.1760231. eCollection 2026.
- Individual participant dataSharing planned: No
Related trials for Food Allergies
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Phase 2b Study of RPT904 as Monotherapy in Participants With IgE-Mediated Food Allergy
Immune System Diseases, Ig-E Mediated Food Allergy
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Observational Study of IgE-Mediated Leguminous Allergies in a Pediatric Population
Hypersensitivity, Food, Legumes Allergy
Not yet recruiting
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Allergy, Food Allergies
Recruiting
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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 Food supplement in people with Food Allergies, 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 7 inclusion and 3 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 17 Dec 2025. 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. Some participants in this study may receive a placebo. 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?
body growth parameters (time frame: after 6 months of treatment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06751810, which also lists 1 linked publication.
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 17 Dec 2025.