AllergyNCT05698030
Efficacy and Saffety of Oral Immunotherapy to Pistachio
An observational study of Allergy and Food Allergy, run by Central Hospital, Nancy, France at 1 site in France.
Trial summary
The objectives of this study are (i) to evaluate the efficacy of oral immunotherapy to pistachio by evaluating the daily oral tolerance of 2g pistachio, by evaluating the long-term tolerance of 15g pistachio (sustained unresponsiveness) and by decreasing pistachio-specific IgE, (ii) evaluating the efficacy of… Read more about this study
- Who is it for?
- Ages 1 year to 18 yearsHealthy volunteers can take part
- Conditions the study is for
- Allergy, Food Allergy
- What is being tested?
- Food allergy
- Type of treatment
- Pill or oral medicine
- How many people
- 50 participants
- Where
- 1 siteFrance
- Study dates
- 1 Jan 2020to 16 Jan 2023
- 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 1 year to 18 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Study population: All patients meeting the inclusion criteria (between 10 and 50)
Who may be able to join
- Patients under 18 years of age with a proven allergy to pistachio and followed in the pediatric allergology unit of the Nancy University Hospital.
- Patients who have received oral immunotherapy to pistachio for at least 18 months at 31/12/2022
Who cannot join
- Patients who have received oral immunotherapy to pistachio for less than 18 months.
- Patients lost to follow-up for more than 2 years or last consultation dating from 2020 or earlier
Trial locations and contacts
1 site in 1 country.
France1 site
Centre Hospitalo-Universitaire de Nancy
Vandœuvre-lès-Nancy, 54511
About this study
Official title: Efficacy of Oral Immunotherapy to Pistachio in Children on the Oral Tolerance to Pistachio and Cashew Nuts
The objectives of this study are (i) to evaluate the efficacy of oral immunotherapy to pistachio by evaluating the daily oral tolerance of 2g pistachio, by evaluating the long-term tolerance of 15g pistachio (sustained unresponsiveness) and by decreasing pistachio-specific IgE, (ii) evaluating the efficacy of pistachio immunotherapy on cashew tolerance, (iii) and to evaluate the safety of pistachio immunotherapy.
- Conditions
- Allergy, Food Allergy
- Being tested
- Food allergy
- Medical subject headings
- Hypersensitivity, Food Hypersensitivity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Food allergyOther
Oral immunotherapy to pistachio
What is being measured
The primary outcome is the main question the study is designed to answer.
Absence of moderate to severe allergic reactions
with daily intake of 2g of pistachio
Measured: during the 6 months of maintenance
Secondary outcomes (5)
Frequency and severity of allergic reactions
Measured: during the dose escalation phase and during the maintenance phase (first 6 months, 1st year, 2nd year, 3rd year)
Decrease in specific IgE and increase of IGg4 to pistachio
Measured: during the dose escalation phase and during the maintenance phase (first 6 months, 1st year, 2nd year, 3rd year)
Tolerance of 1, 2, 4, 8g in isolated doses and 15 g in total cumulative dose of pistachio
during an oral pistachio challenge test
Measured: 3 months after stopping daily consumption of 2g pistachio
Tolerance of 1, 2, 4, 8g in isolated doses and 15 g in total cumulative dose of cashew nut
during an oral cashew nut challenge test
Measured: 3 months after stopping daily consumption of 2g pistachio
Reactogenic or tolerogenic threshold of cashew nuts
Measured: during the dose escalation phase and during the maintenance phase (first 6 months, 1st year, 2nd year, 3rd year)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jan 2023
- Study start1 Jan 2020
- Primary completion1 Jan 2023
- Study completion16 Jan 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AllergyStudies of the same condition, open and under way.
- More trials run by Central Hospital, Nancy, FranceThe 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
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- Central Hospital, Nancy, France
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Amandine DIVARET-CHAUVEAU, Central Hospital, Nancy, France
- Investigators
- Amandine DIVARET-CHAUVEAU, Principal investigator, Centre hospitalo-universitaire de Nancy
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05698030
- Sponsor's protocol ID
- 2022PI182
- Status last verified
- Jan 2023
- First submitted
- 16 Jan 2023
- Last updated
- 26 Jan 2023
- 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 26 Jan 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of Oral Immunotherapy to Pistachio in Children on the Oral Tolerance to Pistachio and Cashew Nuts
- ClinicalTrials.gov ID
- NCT05698030
- Acronym / sponsor ID
- 2022PI182
- Conditions
- Allergy, Food Allergy
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Central Hospital, Nancy, FranceUniversity, hospital or other
- Study start
- 1 Jan 2020 (actual)
- Primary completion
- 1 Jan 2023 (actual)
- Study completion
- 16 Jan 2023 (actual)
- First posted
- 26 Jan 2023 (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 objectives of this study are (i) to evaluate the efficacy of oral immunotherapy to pistachio by evaluating the daily oral tolerance of 2g pistachio, by evaluating the long-term tolerance of 15g pistachio (sustained unresponsiveness) and by decreasing pistachio-specific IgE, (ii) evaluating the efficacy of pistachio immunotherapy on cashew tolerance, (iii) and to evaluate the safety of pistachio immunotherapy.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
Who may qualify
- Ages
- 1 year to 18 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
- Study population
- All patients meeting the inclusion criteria (between 10 and 50)
Key inclusion criteria (2 listed)
- Patients under 18 years of age with a proven allergy to pistachio and followed in the pediatric allergology unit of the Nancy University Hospital.
- Patients who have received oral immunotherapy to pistachio for at least 18 months at 31/12/2022
Key exclusion criteria (2 listed)
- Patients who have received oral immunotherapy to pistachio for less than 18 months.
- Patients lost to follow-up for more than 2 years or last consultation dating from 2020 or earlier
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 allergyOral immunotherapy to pistachio | Other | – |
Primary outcome
Absence of moderate to severe allergic reactions
Time frame: during the 6 months of maintenance
with daily intake of 2g of pistachio
5 secondary outcomes
Frequency and severity of allergic reactions
Time frame: during the dose escalation phase and during the maintenance phase (first 6 months, 1st year, 2nd year, 3rd year)
Decrease in specific IgE and increase of IGg4 to pistachio
Time frame: during the dose escalation phase and during the maintenance phase (first 6 months, 1st year, 2nd year, 3rd year)
Tolerance of 1, 2, 4, 8g in isolated doses and 15 g in total cumulative dose of pistachio
Time frame: 3 months after stopping daily consumption of 2g pistachio
Tolerance of 1, 2, 4, 8g in isolated doses and 15 g in total cumulative dose of cashew nut
Time frame: 3 months after stopping daily consumption of 2g pistachio
Reactogenic or tolerogenic threshold of cashew nuts
Time frame: during the dose escalation phase and during the maintenance phase (first 6 months, 1st year, 2nd year, 3rd year)
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 26 Jan 2023.
- 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.
Amandine DIVARET-CHAUVEAU principal investigator
Centre hospitalo-universitaire de Nancy
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 Allergy and Food Allergy, run by Central Hospital, Nancy, France 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 2 inclusion and 2 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 26 Jan 2023. 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?
Absence of moderate to severe allergic reactions (time frame: during the 6 months of maintenance). 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 26 Jan 2023.