Peanut AllergyOLDTINYpeanutNCT04881773
Oral Low Doses Tolerance INduction Study for Peanuts
An observational study of Peanut Allergy, run by University Hospital, Montpellier at 1 site in France.
Trial summary
Several protocols have been proposed in scientifis literature, for oral tolerance induction (OIT) protocols for peanuts. A meta-analysis showed that the data in the literature are rather in favor of the exclusion of peanuts, and that OIT doesn't allow to expect significant levels of peanut protein consumed by the… Read more about this study
- Who is it for?
- Ages 5 to 65 years
- Conditions the study is for
- Peanut Allergy
- How many people
- 2,000 participants
- Where
- 1 siteFrance
- Study dates
- 1 Sep 2018to 1 Jun 2022
- 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 5 to 65 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Patients older that 5 years of age, with a diagnosis of IgE mediated peanuts allergy, undergoing a oral immunotherapy protocol for peanuts, at the University Hospital of Montpellier (France)
Who may be able to join
- Patients evaluated at the Montpellier University Hospital, Allergy Unit ;
- Patients aged 5 years or older;
- Patients with a history of immediate reaction after consuming peanuts
- AND a positive peanut prick test;
- AND peanut positive specific serum IgE (ImmunoCAP®);
- AND a positive oral peanut challenge test OR a clinical history of anaphylaxis AND peanut-specific IgE> 100 kUA / L (ImmunoCAP®);
- Patients who started peanut OIT between September 2018 and January 2021.
Who cannot join
- Patients in exclusion period determined by a previous study;
- Patients under legal protection, under guardianship or under curatorship;
- Possible poor therapeutic compliance to the OIT protocol;
- Active malignant neoplasia or autoimmune disease;
- Active eosinophilic esophagitis or other gastrointestinal eosinophilic disorders;
- Severe active eczema;
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- Pregnancy ;
- Cardiovascular disease and use of beta blockers and / or ACE inhibitors;
- Chronic urticaria;
- Mastocytosis.
Trial locations and contacts
1 site in 1 country.
About this study
Several protocols have been proposed in scientifis literature, for oral tolerance induction (OIT) protocols for peanuts. A meta-analysis showed that the data in the literature are rather in favor of the exclusion of peanuts, and that OIT doesn't allow to expect significant levels of peanut protein consumed by the patient, and is associated with an increased risk of anaphylaxis and epinephrine use. Also, in most published protocols, patients with a history of anaphylactic shock, severe asthma, or multiple history of anaphylaxis are excluded.
To date, no protocol has been validated for this type of treatment, and each center follows locally validated schemes. In our unit, the investigators use an OIT protocol that starts at low doses (first dose at 2.68 mg peanut protein) and doses increase is scheduled every 4 to 12 weeks (instead of every 2 weeks). The investigators do not exclude patients with asthma or those with a history of peanut anaphylaxis (grade 2 or 3). The investigators have noted that our protocol is associated with a good safety profile and good efficacy, probably due to the fact that the investigators start at low doses and increase the dose with a prolonged delay, compared to previously published protocols. For this reason, the investigators decided to evaluate the results the investigators obtained in our patients and to better analyze the efficacy and safety profile of our protocol.
- Conditions
- Peanut Allergy
- Keywords
- Food allergy, peanuts, Oral Immunotherapy, efficacy, safety, Peanut IgE mediated allergy
- Medical subject headings
- Peanut Hypersensitivity, Food Hypersensitivity
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of patients who reach a tolerated dose
Percentage of patients who reach a tolerated dose of 2000 mg of PP during the ITO and percentage of patients who reach a cumulative tolerated dose of 4400 mg of PP during the oral challenge, carried out at least 6 month after the end of the ITO.
Measured: 24 months
Secondary outcomes (1)
Percentage of patients experiencing side effects during OIT
Percentage of patients experiencing side effects during OIT (classified on the basis of their severity); percentage of patients in whom the tolerated dose of PP could be doubled and tripled, compared to the eliciting dose, assessed during an oral food challenge before the beginning of the OIT; percentage of patients who achieve a tolerated dose of 300 mg of PP and 1000 mg of PP during OIT. By doing a subgroup analysis, we will evaluate the same results in patients with a clinical history of grade 2 or grade three anaphylaxis to peanuts.
Measured: 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 May 2021
- Study start1 Sep 2018
- Primary completion1 Jan 2021
- Study completion1 Jun 2022 (estimated)
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.
- 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
- Retrospective
- Enrolment
- 2,000 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Montpellier
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Davide CAIMMI, Study director, University Hospital, Montpellier
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04881773
- Sponsor's protocol ID
- RECHMPL21_0254
- Acronym
- OLDTINYpeanut
- Status last verified
- May 2021
- First submitted
- 10 May 2021
- Last updated
- 11 May 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: NC
Study at a glance
From the registry record, last updated by the sponsor on 11 May 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Oral Low Doses Tolerance INduction Study for Peanuts
- ClinicalTrials.gov ID
- NCT04881773
- Acronym / sponsor ID
- OLDTINYpeanut / RECHMPL21_0254
- Conditions
- Peanut Allergy
- Keywords
- Food allergy, peanuts, Oral Immunotherapy, efficacy, safety, Peanut IgE mediated allergy
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 2,000 participants (actual)
- Lead sponsor
- University Hospital, MontpellierUniversity, hospital or other
- Study start
- 1 Sep 2018 (actual)
- Primary completion
- 1 Jan 2021 (actual)
- Study completion
- 1 Jun 2022 (estimated)
- First posted
- 11 May 2021 (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.
Several protocols have been proposed in scientifis literature, for oral tolerance induction (OIT) protocols for peanuts. A meta-analysis showed that the data in the literature are rather in favor of the exclusion of peanuts, and that OIT doesn't allow to expect significant levels of peanut protein consumed by the patient, and is associated with an increased risk of anaphylaxis and epinephrine use. Also, in most published protocols, patients with a history of anaphylactic shock, severe asthma, or multiple history of anaphylaxis are excluded.
To date, no protocol has been validated for this type of treatment, and each center follows locally validated schemes. In our unit, the investigators use an OIT protocol that starts at low doses (first dose at 2.68 mg peanut protein) and doses increase is scheduled every 4 to 12 weeks (instead of every 2 weeks). The investigators do not exclude patients with asthma or those with a history of peanut anaphylaxis (grade 2 or 3). The investigators have noted that our protocol is associated with a good safety profile and good efficacy, probably due to the fact that the investigators start at low doses and increase the dose with a prolonged delay, compared to previously published protocols. For this reason, the investigators decided to evaluate the results the investigators obtained in our patients and to better analyze the efficacy and safety profile of our protocol.
Study design
- Observational model
- Case only
- Time perspective
- Retrospective
Who may qualify
- Ages
- 5 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Patients older that 5 years of age, with a diagnosis of IgE mediated peanuts allergy, undergoing a oral immunotherapy protocol for peanuts, at the University Hospital of Montpellier (France)
Key inclusion criteria (7 listed)
- Patients evaluated at the Montpellier University Hospital, Allergy Unit ;
- Patients aged 5 years or older;
- Patients with a history of immediate reaction after consuming peanuts
- AND a positive peanut prick test;
- AND peanut positive specific serum IgE (ImmunoCAP®);
Key exclusion criteria (10 listed)
- Patients in exclusion period determined by a previous study;
- Patients under legal protection, under guardianship or under curatorship;
- Possible poor therapeutic compliance to the OIT protocol;
- Active malignant neoplasia or autoimmune disease;
- Active eosinophilic esophagitis or other gastrointestinal eosinophilic disorders;
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
Percentage of patients who reach a tolerated dose
Time frame: 24 months
Percentage of patients who reach a tolerated dose of 2000 mg of PP during the ITO and percentage of patients who reach a cumulative tolerated dose of 4400 mg of PP during the oral challenge, carried out at least 6 month after the end of the ITO.
1 secondary outcome
Percentage of patients experiencing side effects during OIT
Time frame: 24 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 May 2021.
- Individual participant dataSharing planned: Undecided. NC
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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.
Davide CAIMMI study director
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 7 inclusion and 10 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: status not confirmed, as of the sponsor's last update on 11 May 2021. 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?
Results are not available in the source record.
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?
Percentage of patients who reach a tolerated dose (time frame: 24 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 11 May 2021.