Peanut AllergyPeaNewTNCT03852342
Reactive Doses and Times During Oral Food Challenge to Peanut
An observational study of Peanut Allergy, run by University Hospital, Montpellier at 1 site in France.
Trial summary
Peanut allergy is a growing public health problem in developed countries with more and more hospitalizations for anaphylaxis. It has been determined that sensitization to certain peanut proteins such as rAra h 2, is predictive of allergy and could predict the severity of reaction (anaphylaxis) during Oral food… Read more about this study
- Who is it for?
- Ages 2 years and older
- Conditions the study is for
- Peanut Allergy
- How many people
- 262 participants
- Where
- 1 siteFrance
- Study dates
- 10 Oct 2018to 20 Mar 2019
- 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 2 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: All patients with a clinical suspicion of peanut allergy who underwent an open OFC to peanut between June 2001 to July 2018 in the Allergy Unit of the University Hospital of Montpellier (France).
Who may be able to join
- Patients with a clinical suspicion of peanut allergy who underwent OFC to peanut
- Patients not objecting to participate in the study
- Men and women are included
Who cannot join
- The patient refused to participate in the study
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Reactive Doses and Times During Oral Food Challenge (OFC) to Peanut
Peanut allergy is a growing public health problem in developed countries with more and more hospitalizations for anaphylaxis. It has been determined that sensitization to certain peanut proteins such as rAra h 2, is predictive of allergy and could predict the severity of reaction (anaphylaxis) during Oral food challenges (OFC). So far, consensual threshold for cutaneous test and IgE as predictor in the positivity of OFC have not been determined. Identification of reactive doses for OFC and phenotype of patients would help to personalize management of patients subgroups, with an optimal security.
- Conditions
- Peanut Allergy
- Keywords
- Anaphylaxis, Oral Food Challenge, Hypersensitivity, Food Allergy, Peanut
- Medical subject headings
- Peanut Hypersensitivity, Anaphylaxis, Hypersensitivity, Food Hypersensitivity
What is being measured
The primary outcome is the main question the study is designed to answer.
Reactive doses of peanut (mg) at which an allergic reaction appears in patients with positive peanut Oral Food Challenge
An Oral Food Challenge consists in the ingestion of the suspected allergic food. The patient is given increased dose levels of this food throughout a day. The OFC is positive when the patient presents a clinical reaction (clinical symptoms linked to an allergic response) triggered by the food ingested.
We'll gather the data of all patients who came in our unit of Allergology and who had a positive peanut OFC.
The reactive dose is calculated from the total cumulative dose (mg) of peanut reached when the OFC peanut is considered positive.
The reactive dose is considered as a time dependent data and will be analyzed with survival data analysis methods.
The analyzed event is a positive OFC
Measured: 1 day
Secondary outcomes (3)
Time between the reaction and the last administered dose
Time between the reaction and the last administered dose
Measured: 1 day
Identifying risk factors of peanut hypersensitivity
To identify the risk factors, that remain significantly associated with a positive peanut OFC
Measured: 1 day
Risk factors of anaphylaxis during a positive peanut OFC
To identify, among the collected data on the patient's clinical history detailled below, the risk factors of occurrence of an anaphylactic reaction during peanut OFC.
Anaphylaxis is defined as a severe allergic reaction that appears quickly and has a fatal potential. It is usually characterized by the appearance of several signs and symptoms that can affect one or more systems of our body.
Measured: 1 day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Feb 2019
- Study start10 Oct 2018
- Primary completion28 Feb 2019
- Study completion20 Mar 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Peanut AllergyStudies of the same condition, open and under way.
- More trials run by University Hospital, MontpellierThe 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
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 262 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Montpellier
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Pascal DEMOLY, MD, PhD, Principal investigator, University Hospital, Montpellier
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03852342
- Sponsor's protocol ID
- RECHMPL18_0344
- Acronym
- PeaNewT
- Status last verified
- Sep 2018
- First submitted
- 12 Sep 2018
- Last updated
- 18 Apr 2019
- 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 18 Apr 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Reactive Doses and Times During Oral Food Challenge (OFC) to Peanut
- ClinicalTrials.gov ID
- NCT03852342
- Acronym / sponsor ID
- PeaNewT / RECHMPL18_0344
- Conditions
- Peanut Allergy
- Keywords
- Anaphylaxis, Oral Food Challenge, Hypersensitivity, Food Allergy, Peanut
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 262 participants (actual)
- Lead sponsor
- University Hospital, MontpellierUniversity, hospital or other
- Study start
- 10 Oct 2018 (actual)
- Primary completion
- 28 Feb 2019 (actual)
- Study completion
- 20 Mar 2019 (actual)
- First posted
- 25 Feb 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.
Peanut allergy is a growing public health problem in developed countries with more and more hospitalizations for anaphylaxis. It has been determined that sensitization to certain peanut proteins such as rAra h 2, is predictive of allergy and could predict the severity of reaction (anaphylaxis) during Oral food challenges (OFC). So far, consensual threshold for cutaneous test and IgE as predictor in the positivity of OFC have not been determined. Identification of reactive doses for OFC and phenotype of patients would help to personalize management of patients subgroups, with an optimal security.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
Who may qualify
- Ages
- 2 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- All patients with a clinical suspicion of peanut allergy who underwent an open OFC to peanut between June 2001 to July 2018 in the Allergy Unit of the University Hospital of Montpellier (France).
Key inclusion criteria (3 listed)
- Patients with a clinical suspicion of peanut allergy who underwent OFC to peanut
- Patients not objecting to participate in the study
- Men and women are included
Key exclusion criteria (1 listed)
- The patient refused to participate in the study
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Reactive doses of peanut (mg) at which an allergic reaction appears in patients with positive peanut Oral Food Challenge
Time frame: 1 day
An Oral Food Challenge consists in the ingestion of the suspected allergic food. The patient is given increased dose levels of this food throughout a day. The OFC is positive when the patient presents a clinical reaction (clinical symptoms linked to an allergic response) triggered by the food ingested. We'll gather the data of all patients who came in our unit of Allergology and who had a positive peanut OFC. The reactive dose is calculated from the total cumulative dose (mg) of peanut reached when the OFC peanut is considered positive. The reactive dose is considered as a time dependent data and will be analyzed with survival data analysis methods. The analyzed event is a positive OFC
3 secondary outcomes
Time between the reaction and the last administered dose
Time frame: 1 day
Identifying risk factors of peanut hypersensitivity
Time frame: 1 day
Risk factors of anaphylaxis during a positive peanut OFC
Time frame: 1 day
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 18 Apr 2019.
- 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.
Pascal DEMOLY, MD, PhD principal investigator
University Hospital, Montpellier
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 Peanut Allergy, run by University Hospital, Montpellier 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 3 inclusion and 1 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 18 Apr 2019. 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?
Reactive doses of peanut (mg) at which an allergic reaction appears in patients with positive peanut Oral Food Challenge (time frame: 1 day). 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 18 Apr 2019.