Cow's Milk AllergyMERLINNCT06481280
Evaluation of Tolerance, Efficacy and Safety of an Hydrolyzed Formula in Infants With IgE/Non-IgE Mediated CMA.
A study testing Test Formula in people with Cow's Milk Allergy, run by United Pharmaceuticals at 2 sites in 2 countries.
Trial summary
The aim of this interventional study is to assess the hypoallergenicity of a new formula in infants having a cow milk allergy (CMA), whatever the type of CMA, meaning in both IgE-mediated and non-IgE-mediated CMA patients. Read more about this study
- Who is it for?
- Ages 1 month to 24 months
- Conditions the study is for
- Cow's Milk Allergy
- What is being tested?
- Test Formula
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 70 participants
- Where
- 2 sitesin 2 countries
- Study dates
- 14 Aug 2024to Jun 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 1 month to 24 months
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- between 1 and 24 months old
- having a CMA proven in the last 3 months prior to inclusion
- free of clinical allergic symptoms for at least one week (i.e., successfully fed an elimination diet)
- whose parent(s)/legal guardian(s) signed the informed consent form.
- Main Exclusion Criteria:
- Children mainly (\>1 breastfeeding/day) or exclusively breastfed, with maternal willingness to continue breast-feeding
Show all 11Show fewer
- Children with a mean formula intake lower than 250 ml/day
- Children with past anaphylactic reaction(s)
- Children with chronic (non acute) FPIES
- -- Children presenting with any situation which, according to the investigator, may interfere with the study participation, or lead to a particular risk for the subject,
- Children already participating in another clinical trial
Who cannot join
None listed.
Trial locations and contacts
2 sites in 2 countries.
2 sites in 2 countries
About this study
Official title: Cow's Milk Allergy (CMA): Evaluation of Tolerance, Efficacy and Safety of a Thickened Extensively Hydrolyzed Formula in Infants With IgE and Non-IgE Mediated CMA
The aim of this interventional study is to assess the hypoallergenicity of a new formula in infants having a cow milk allergy (CMA), whatever the type of CMA, meaning in both IgE-mediated and non-IgE-mediated CMA patients.
This will be tested through a double-blind placebo controlled food challenge (DBPCFC) taking place over 2 or 3 separate days, in hospital.
If the child tolerates the tested formula during the DBPCFC, he will be fed with the test formula during the second study phase. There will be monthly visit and parents will be asked to fill in diaries.
Read the detailed description
Briefly, on two separate days, the placebo formula and the TEHCF will be introduced at increasing doses under medical supervision, and appearance of allergic symptoms will be witnessed and recorded if any. The week after, and more particularly the 72 hours after each food challenge day, child's parents will be instructed to report to the investigator any delayed reaction that may occur. In case the TEHCF induces an allergic reaction, the child's participation will be ended. Otherwise, the child will enter the second study part, lasting 4 months and during which the usual formula taken by the child will be totally replaced by the TEHCF.
- Conditions
- Cow's Milk Allergy
- Being tested
- Test Formula, Placebo Formula
- Keywords
- CMA (Cow's Milk Allergy), DBPCFC (Double-Blind Placebo-Controlled Food Challenge), FA (Food Allergy), IgE (Immunoglobulin E), OFC (Oral Food Challenge)
- Medical subject headings
- Milk Hypersensitivity, Food Hypersensitivity, Epilepsy, Idiopathic Generalized, Orofacial Cleft 1
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Test FormulaDietary supplement
Infants will receive an extensively hydrolyzed formula during the double-blind placebo-controlled food challenge (DBPCFC) and will continue on this formula during the open-label feeding phase if they tolerate it.
Placebo FormulaDietary supplement
Infants will receive a placebo formula during the DBPCFC to compare against the test formula.
| Study group | Role | What they receive |
|---|---|---|
| Test Formula | Experimental | Infants will receive an extensively hydrolyzed formula during the double-blind placebo-controlled food challenge (DBPCFC) and will continue on this formula during the open-label feeding phase if they tolerate it. Receives: Dietary Supplement: Test Formula; Dietary Supplement: Placebo Formula |
| Placebo Formula | Placebo comparator | Infants will receive a placebo formula (=their previous formula) during the DBPCFC to compare against the test formula. Receives: Dietary Supplement: Test Formula; Dietary Supplement: Placebo Formula |
What is being measured
The primary outcome is the main question the study is designed to answer.
Hypoallergenicity of the formula
the percentage of children tolerating the formula during the double blind placebo controlled food challenge
Measured: 7 days
Secondary outcomes (14)
Cow's Milk Related Symptom Score (CoMiSS™)
The Cow's Milk Related Symptom Score (CoMiSS™) will be evaluated globally and each of its subscore. CoMiSS ranges from 0 to 33 (worst outcome).
Measured: At each visit : day7, day 30, day 60, day 90 and day 120
Atopic dermatitis severity - SCORing Atopic Dermatitis (SCORAD) Index
Atopic dermatitis is assessed using the SCORing Atopic Dermatitis (SCORAD) Index. The score ranges from 0 to 103 (most severe state) and is used to determine the stages of severity of AD.
Measured: At each visit : day7, day 30, day 60, day 90 and day 120
Gastrointestinal CMA symptoms
the other Gastrointestinal CMA symptoms (not described by the COMISS) will be reported (such as acute diarrhea, constipation...)
Measured: At each visit : day7, day 30, day 60, day 90 and day 120
Cutaneous CMA symptoms
Others Cutaneous CMA symptoms besides those evaluated in the CoMISS and the SCORAD will be described
Measured: At each visit : day7, day 30, day 60, day 90 and day 120
Sleep characteristics
This measures focuses on evaluating the quality and duration of sleep in children consuming the test.
Measured: At each visit : day7, day 30, day 60, day 90 and day 120
Weight
Weight will be expressed in kg and in z scores according to the World Health Organization (WHO) Child Growth Standards.
Measured: At each monthly visit day 30, day 60, day 90 and day 120
Height
Height will be expressed in cm and in z scores according to the WHO Child Growth Standards.
Measured: At each monthly visit day 30, day 60, day 90 and day 120
Head circumference
Head circumference will be expressed in cm and in z scores according to the WHO Child Growth Standards.
Measured: At each monthly visit day 30, day 60, day 90 and day 120
BMI
BMI will be expressed in value and z scores according to the WHO Child Growth Standards.
Measured: At each monthly visit day 30, day 60, day 90 and day 120
Adverse event
Any untoward medical reaction occuring from the signatture of the consent until the end of the participant's participation
Measured: During the whole study duration
Compliance
It will be assessed through the volume of formula consumed
Measured: At each visit : day7, day 30, day 60, day 90 and day 120
Parents' satisfaction
Satisfaction regarding the effect of the study formula on regurgitations, stool consistency, digestive comfort, and the acceptability of the formula by the child will be evaluated by using a 5-level satisfaction scale (very satisfied/satisfied/unsatisfied/very unsatisfied / without opinion)
Measured: At each visit : day7, day 30, day 60, day 90 and day 120
Investigator's satisfaction
paediatrician's satisfaction with the effect of the study formula on the child) will be assessed by using a 4-level satisfaction scale (very satisfied/satisfied/unsatisfied/very unsatisfied).
Measured: At each visit : day7, day 30, day 60, day 90 and day 120
Digestive tolerance
Digestive tolerance of the formula will be assessed by monitoring stool frequency and consistency, regurgitations, abdominal pain/painful flatus/ bloating, crying time, irritability time.
Measured: At each visit : day7, day 30, day 60, day 90 and day 120
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Jul 2024
- Study start14 Aug 2024
- Primary completionJan 2026 (estimated)
- Study completionJun 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cow's Milk AllergyStudies of the same condition, open and under way.
- 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
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- The first part of the study consists in a double-blind placebo-controlled food challenge (DBPCFC) during which all patient will receive the test formula and a placebo, in a randomised order. During the second part of the study, all patients will be fed the test formula (open-label phase).
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 70 participants (estimated)
Sponsor and investigators
- Lead sponsor
- United Pharmaceuticals
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Slb Pharma
- Responsible party
- Sponsor
- Investigators
- Salvatore OLIVA, MD, PhD, Principal investigator, University Hospital - Umberto I
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06481280
- Sponsor's protocol ID
- UP2022-01-MERLIN
- Acronym
- MERLIN
- Status last verified
- Jan 2025
- First submitted
- 20 Jun 2024
- Last updated
- 7 Jan 2025
- 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 7 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cow's Milk Allergy (CMA): Evaluation of Tolerance, Efficacy and Safety of a Thickened Extensively Hydrolyzed Formula in Infants With IgE and Non-IgE Mediated CMA
- ClinicalTrials.gov ID
- NCT06481280
- Acronym / sponsor ID
- MERLIN / UP2022-01-MERLIN
- Conditions
- Cow's Milk Allergy
- Keywords
- CMA (Cow's Milk Allergy), DBPCFC (Double-Blind Placebo-Controlled Food Challenge), FA (Food Allergy), IgE (Immunoglobulin E), OFC (Oral Food Challenge)
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 70 participants (estimated)
- Lead sponsor
- United PharmaceuticalsIndustry (pharma, biotech, devices)
- Collaborators
- Slb Pharma
- Study start
- 14 Aug 2024 (actual)
- Primary completion
- Jan 2026 (estimated)
- Study completion
- Jun 2026 (estimated)
- First posted
- 1 Jul 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.
The aim of this interventional study is to assess the hypoallergenicity of a new formula in infants having a cow milk allergy (CMA), whatever the type of CMA, meaning in both IgE-mediated and non-IgE-mediated CMA patients.
This will be tested through a double-blind placebo controlled food challenge (DBPCFC) taking place over 2 or 3 separate days, in hospital.
If the child tolerates the tested formula during the DBPCFC, he will be fed with the test formula during the second study phase. There will be monthly visit and parents will be asked to fill in diaries.
Detailed description
Briefly, on two separate days, the placebo formula and the TEHCF will be introduced at increasing doses under medical supervision, and appearance of allergic symptoms will be witnessed and recorded if any. The week after, and more particularly the 72 hours after each food challenge day, child's parents will be instructed to report to the investigator any delayed reaction that may occur. In case the TEHCF induces an allergic reaction, the child's participation will be ended. Otherwise, the child will enter the second study part, lasting 4 months and during which the usual formula taken by the child will be totally replaced by the TEHCF.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- The first part of the study consists in a double-blind placebo-controlled food challenge (DBPCFC) during which all patient will receive the test formula and a placebo, in a randomised order. During the second part of the study, all patients will be fed the test formula (open-label phase).
| Arm | Type | Receives |
|---|---|---|
| Test Formula | Experimental | Dietary Supplement: Test Formula, Dietary Supplement: Placebo FormulaInfants will receive an extensively hydrolyzed formula during the double-blind placebo-controlled food challenge (DBPCFC) and will continue on this formula during the open-label feeding phase if they tolerate it. |
| Placebo Formula | Placebo comparator | Dietary Supplement: Test Formula, Dietary Supplement: Placebo FormulaInfants will receive a placebo formula (=their previous formula) during the DBPCFC to compare against the test formula. |
Who may qualify
- Ages
- 1 month to 24 months
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (11 listed)
- between 1 and 24 months old
- having a CMA proven in the last 3 months prior to inclusion
- free of clinical allergic symptoms for at least one week (i.e., successfully fed an elimination diet)
- whose parent(s)/legal guardian(s) signed the informed consent form.
- Children mainly (\>1 breastfeeding/day) or exclusively breastfed, with maternal willingness to continue breast-feeding
Key exclusion criteria (0 listed)
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 |
|---|---|---|
| Test FormulaInfants will receive an extensively hydrolyzed formula during the double-blind placebo-controlled food challenge (DBPCFC) and will continue on this formula during the open-label feeding phase if they tolerate it. | Dietary supplement | Placebo Formula, Test Formula |
| Placebo FormulaInfants will receive a placebo formula during the DBPCFC to compare against the test formula. | Dietary supplement | Placebo Formula, Test Formula |
Primary outcome
Hypoallergenicity of the formula
Time frame: 7 days
the percentage of children tolerating the formula during the double blind placebo controlled food challenge
14 secondary outcomes
Cow's Milk Related Symptom Score (CoMiSS™)
Time frame: At each visit : day7, day 30, day 60, day 90 and day 120
Atopic dermatitis severity - SCORing Atopic Dermatitis (SCORAD) Index
Time frame: At each visit : day7, day 30, day 60, day 90 and day 120
Gastrointestinal CMA symptoms
Time frame: At each visit : day7, day 30, day 60, day 90 and day 120
Cutaneous CMA symptoms
Time frame: At each visit : day7, day 30, day 60, day 90 and day 120
Sleep characteristics
Time frame: At each visit : day7, day 30, day 60, day 90 and day 120
Weight
Time frame: At each monthly visit day 30, day 60, day 90 and day 120
Height
Time frame: At each monthly visit day 30, day 60, day 90 and day 120
Head circumference
Time frame: At each monthly visit day 30, day 60, day 90 and day 120
BMI
Time frame: At each monthly visit day 30, day 60, day 90 and day 120
Adverse event
Time frame: During the whole study duration
Compliance
Time frame: At each visit : day7, day 30, day 60, day 90 and day 120
Parents' satisfaction
Time frame: At each visit : day7, day 30, day 60, day 90 and day 120
Investigator's satisfaction
Time frame: At each visit : day7, day 30, day 60, day 90 and day 120
Digestive tolerance
Time frame: At each visit : day7, day 30, day 60, day 90 and day 120
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Jan 2025.
- Individual participant dataSharing planned: No
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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.
Salvatore OLIVA, MD, PhD principal investigator
University Hospital - Umberto I
2 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Test Formula in people with Cow's Milk Allergy, run by United Pharmaceuticals at 2 sites in 2 countries.
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 11 inclusion and 0 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: under way, not looking for participants, as of the sponsor's last update on 7 Jan 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Belgium, 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?
This study is still under way. Results are not available in the source record yet.
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?
Hypoallergenicity of the formula (time frame: 7 days). 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 7 Jan 2025.