Peanut AllergyNCT03849079
Validation of the HYPONUT Product
A study testing Hyponut in people with Peanut Allergy, run by University Hospital, Montpellier at 1 site in France.
Trial summary
The HYPONUT product was previously validated in a laboratory setting ("Procédé de préparation d'aliment hypoallergénique", n° FR1250977) on 2012. A international patent was then obtained on 2013. Read more about this study
- Who is it for?
- Ages 6 years and older
- Conditions the study is for
- Peanut Allergy
- What is being tested?
- Hyponut
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 6 participants
- Where
- 1 siteFrance
- Study dates
- 24 Sep 2019to 4 Feb 2020
- Phase
- Interventional
- 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 6 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Patients aged more than 6
- Patients suffering from peanut allergy and followed in the Allergy Unit of the University Hospital of Montpellier (France)
Who cannot join
- Pregnancy, or patients breast-feeding
- Patients treated with drugs possibly altering the results of the tests (e.g. anti-histamines)
- Patients presenting with dermographism
- Patients not fluent in French
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Clinical Validation of the Inactivation Procedure for Peanut Major Allergens in the HYPONUT Product
The HYPONUT product was previously validated in a laboratory setting ("Procédé de préparation d'aliment hypoallergénique", n° FR1250977) on 2012. A international patent was then obtained on 2013. Through the present study, the investigators would like to prove that the hypoallergenicity of the product is sustained in a clinical setting. Patients allergic to peanuts currently undergo in vivo tests to confirm their allergy: skin prick tests, and oral food challenges. In vitro tests are also performed (i.e. IgE levels for peanut and peanut components). The follow-up of patients consists in regular yearly or semestral evaluations. During one of these evaluation, the investigators will skin tests patients with the hyponut product to verify if they are sensitized to this last one as well. When skin tests will be negative, the investigators will propose to patients to take some of the product to verify its tolerability as well.
- Conditions
- Peanut Allergy
- Being tested
- Hyponut
- Keywords
- Peanut Allergy, Skin Prick Test, Oral Food Challenge, Hyponut
- Medical subject headings
- Peanut Hypersensitivity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HyponutOther
Prick tests with hyponut
| Study group | Role | What they receive |
|---|---|---|
| Hyponut | Experimental | Not described Receives: Other: Hyponut |
What is being measured
The primary outcome is the main question the study is designed to answer.
Skin Prick Tests evaluation
Measured: day patient enrolled
Secondary outcomes (1)
Oral food challenge evaluation
Measured: day patient enrolled
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Feb 2019
- Study start24 Sep 2019
- Primary completion4 Feb 2020
- Study completion4 Feb 2020
Why it stopped: All prick tests are positive
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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 6 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Montpellier
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03849079
- Sponsor's protocol ID
- UF 7542
- Status last verified
- Nov 2020
- First submitted
- 19 Feb 2019
- Last updated
- 27 Nov 2020
- 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 27 Nov 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Validation of the Inactivation Procedure for Peanut Major Allergens in the HYPONUT Product
- ClinicalTrials.gov ID
- NCT03849079
- Acronym / sponsor ID
- UF 7542
- Conditions
- Peanut Allergy
- Keywords
- Peanut Allergy, Skin Prick Test, Oral Food Challenge, Hyponut
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: All prick tests are positive
- Enrolment
- 6 participants (actual)
- Lead sponsor
- University Hospital, MontpellierUniversity, hospital or other
- Study start
- 24 Sep 2019 (actual)
- Primary completion
- 4 Feb 2020 (actual)
- Study completion
- 4 Feb 2020 (actual)
- First posted
- 21 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.
The HYPONUT product was previously validated in a laboratory setting ("Procédé de préparation d'aliment hypoallergénique", n° FR1250977) on 2012. A international patent was then obtained on 2013. Through the present study, the investigators would like to prove that the hypoallergenicity of the product is sustained in a clinical setting. Patients allergic to peanuts currently undergo in vivo tests to confirm their allergy: skin prick tests, and oral food challenges. In vitro tests are also performed (i.e. IgE levels for peanut and peanut components). The follow-up of patients consists in regular yearly or semestral evaluations. During one of these evaluation, the investigators will skin tests patients with the hyponut product to verify if they are sensitized to this last one as well. When skin tests will be negative, the investigators will propose to patients to take some of the product to verify its tolerability as well.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Hyponut | Experimental | Other: Hyponut |
Who may qualify
- Ages
- 6 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (2 listed)
- Patients aged more than 6
- Patients suffering from peanut allergy and followed in the Allergy Unit of the University Hospital of Montpellier (France)
Key exclusion criteria (4 listed)
- Pregnancy, or patients breast-feeding
- Patients treated with drugs possibly altering the results of the tests (e.g. anti-histamines)
- Patients presenting with dermographism
- Patients not fluent in French
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 |
|---|---|---|
| HyponutPrick tests with hyponut | Other | Hyponut |
Primary outcome
Skin Prick Tests evaluation
Time frame: day patient enrolled
1 secondary outcome
Oral food challenge evaluation
Time frame: day patient enrolled
Results and safety
The study was stopped early (reason given: All prick tests are positive). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Nov 2020.
- 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.
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?
A study testing Hyponut in people with 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 2 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: stopped early, as of the sponsor's last update on 27 Nov 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 was stopped early (reason given: All prick tests are positive). 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?
Skin Prick Tests evaluation (time frame: day patient enrolled). 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 27 Nov 2020.