Food Allergy in InfantsNCT04651829
Suspicion of Non IgE-mediated Cow's Milk Protein Allergy: Prevalence and Evolution
An observational study of Food Allergy in Infants and Proctocolitis, run by Hôpital Armand Trousseau at 1 site in France.
Trial summary
Cow's milk protein allergy (CMPA) is often evoked in infants, in particular in front of delayed symptoms such as rectal bleeding, atopic dermatitis, excessive crying, reflux, failure to thrive... Read more about this study
- Who is it for?
- Ages Up to 4 months
- Conditions the study is for
- Food Allergy in Infants, Proctocolitis, Atopic Dermatitis
- What is being tested?
- oral food challenge 1 and oral food challenge 2
- Type of treatment
- Pill or oral medicine
- How many people
- 100 participants
- Where
- 1 siteFrance
- Study dates
- May 2014to Dec 2017
- Phase
- Observational
- 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 Up to 4 months
- All sexes
- No healthy volunteers
- Child
Study population: All infants under 4 months of age consulting for delayed symptoms evoking CMPA are prospectively included. All these infants benefit from a CMP elimination diet by replacing their usual formula with an extensive CMP hydrolysate, hydrolysed rice-protein formula, or an amino acid-based formula (AAF). Only children whose symptoms disappear after this exclusion diet are selected for the study.
Who may be able to join
- infants under 4 months age with delayed symptoms evoking CMPA
Who cannot join
- exclusively breastfed infants
- no improvement of symptoms despite amino acid formula
- patients with symptoms of food protein induced enterocolitis
- patients who do not have diagnostic oral food challenge within 3 months after the start of elimination diet
Trial locations and contacts
1 site in 1 country.
France1 site
Pediatric nutrition and gastroenterology department, Trousseau Hospital, APHP
Paris, 75012
About this study
Cow's milk protein allergy (CMPA) is often evoked in infants, in particular in front of delayed symptoms such as rectal bleeding, atopic dermatitis, excessive crying, reflux, failure to thrive... But in case of non IgE-mediated CMPA, the only way to diagnose this allergy is to proceed to an elimination-reintroduction test over a period of 2 to 4 weeks, to improve symptoms first, and then provoke them. Even if the diagnosis is confirmed, we speculate that non IgE-mediated CMPA has a faster resolution than other CMPA.
The first aim of this study is to estimate the prevalence of non IgE-mediated CMPA in a cohort of infants with delayed symptoms which could be relied to a CMPA. The second goal is evaluate the age of tolerance in non IgE-mediated CMPA with oral food challenge for milk ever 2 months after 4 months of age.
- Conditions
- Food Allergy in Infants, Proctocolitis, Atopic Dermatitis, Reflux, Gastroesophageal, Tolerance
- Being tested
- oral food challenge 1, oral food challenge 2
- Medical subject headings
- Proctocolitis, Dermatitis, Atopic, Gastroesophageal Reflux
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
oral food challenge 1Other
First oral food challenge after a short period of several weeks of avoidance of CMP to confirm diagnosis of CMPA
oral food challenge 2Other
Second oral food challenge to test tolerance after 4 months of age if confirmed CMPA
What is being measured
The primary outcome is the main question the study is designed to answer.
prevalence of CMPA in patients with suspicion of non IgE-mediated CMPA
We proceed to an elimination-reintroduction test of the culprit food (CMP) in patients with delayed symptoms of non IgE-mediated CMPA (rectal bleeding, atopic dermatitis, reflux, excessive crying, failure to thrive...) after a period of two to eight weeks of exclusion of CMP.
If symptoms disappear after CMP elimination, and reappear after CMP reintroduction, the diagnosis of CMPA is confirmed.
Measured: 2 to 8 weeks after inclusion
Secondary outcomes (1)
age of tolerance of confirmed non IgE-mediated CMPA
We proceed to an oral food challenge (OFC) for CMP every 2 months, after the age of 4 months, and after at least 2 months of elimination diet. If symptoms occur after OFC, the patient is still allergic. If no symptom occur after OFC, the patient is considered as tolerant for CMP, and that determine age of tolerance.
Measured: after 4 months of age, and at least after 2 months of elimination diet, and then ever 2 months until tolerance
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Dec 2020
- Study startMay 2014
- Primary completionMay 2014
- Study completionDec 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Food Allergy in InfantsStudies 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
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hôpital Armand Trousseau
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Anaïs Lemoine, Hôpital Armand Trousseau
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04651829
- Sponsor's protocol ID
- CMPA
- Status last verified
- Nov 2020
- First submitted
- 26 Nov 2020
- Last updated
- 3 Dec 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 3 Dec 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Suspicion of Non IgE-mediated Cow's Milk Protein Allergy: Prevalence and Evolution
- ClinicalTrials.gov ID
- NCT04651829
- Acronym / sponsor ID
- CMPA
- Conditions
- Food Allergy in Infants, Proctocolitis, Atopic Dermatitis, Reflux, Gastroesophageal, Tolerance
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Hôpital Armand TrousseauUniversity, hospital or other
- Study start
- May 2014 (actual)
- Primary completion
- May 2014 (actual)
- Study completion
- Dec 2017 (actual)
- First posted
- 3 Dec 2020 (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.
Cow's milk protein allergy (CMPA) is often evoked in infants, in particular in front of delayed symptoms such as rectal bleeding, atopic dermatitis, excessive crying, reflux, failure to thrive... But in case of non IgE-mediated CMPA, the only way to diagnose this allergy is to proceed to an elimination-reintroduction test over a period of 2 to 4 weeks, to improve symptoms first, and then provoke them. Even if the diagnosis is confirmed, we speculate that non IgE-mediated CMPA has a faster resolution than other CMPA.
The first aim of this study is to estimate the prevalence of non IgE-mediated CMPA in a cohort of infants with delayed symptoms which could be relied to a CMPA. The second goal is evaluate the age of tolerance in non IgE-mediated CMPA with oral food challenge for milk ever 2 months after 4 months of age.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
Who may qualify
- Ages
- Up to 4 months
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- Study population
- All infants under 4 months of age consulting for delayed symptoms evoking CMPA are prospectively included. All these infants benefit from a CMP elimination diet by replacing their usual formula with an extensive CMP hydrolysate, hydrolysed rice-protein formula, or an amino acid-based formula (AAF). Only children whose symptoms disappear after this exclusion diet are selected for the study.
Key inclusion criteria (1 listed)
- infants under 4 months age with delayed symptoms evoking CMPA
Key exclusion criteria (4 listed)
- exclusively breastfed infants
- no improvement of symptoms despite amino acid formula
- patients with symptoms of food protein induced enterocolitis
- patients who do not have diagnostic oral food challenge within 3 months after the start of elimination diet
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 |
|---|---|---|
| oral food challenge 1First oral food challenge after a short period of several weeks of avoidance of CMP to confirm diagnosis of CMPA | Other | – |
| oral food challenge 2Second oral food challenge to test tolerance after 4 months of age if confirmed CMPA | Other | – |
Primary outcome
prevalence of CMPA in patients with suspicion of non IgE-mediated CMPA
Time frame: 2 to 8 weeks after inclusion
We proceed to an elimination-reintroduction test of the culprit food (CMP) in patients with delayed symptoms of non IgE-mediated CMPA (rectal bleeding, atopic dermatitis, reflux, excessive crying, failure to thrive...) after a period of two to eight weeks of exclusion of CMP. If symptoms disappear after CMP elimination, and reappear after CMP reintroduction, the diagnosis of CMPA is confirmed.
1 secondary outcome
age of tolerance of confirmed non IgE-mediated CMPA
Time frame: after 4 months of age, and at least after 2 months of elimination diet, and then ever 2 months until tolerance
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 3 Dec 2020.
- Individual participant dataSharing planned: Undecided
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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?
An observational study of Food Allergy in Infants and Proctocolitis, run by Hôpital Armand Trousseau at 1 site in France.
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 4 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 3 Dec 2020. 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 France. 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?
prevalence of CMPA in patients with suspicion of non IgE-mediated CMPA (time frame: 2 to 8 weeks after inclusion). 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 3 Dec 2020.