Peanut Allergic SubjectsNCT07895095
Oral Immunotherapy for Children With Peanut Allergy
A study testing Oral immunotherapy with peanut in people with Peanut Allergic Subjects and Peanut Allergies, run by Laura Ozer Kettner at 5 sites in Denmark.
Trial summary
This clinical trial aims to investigate if oral immunotherapy can help children with peanut allergy tolerate peanut. Children aged 6 months to 4 years can take part in the trial. Read more about this study
- Who is it for?
- Ages 6 to 48 months
- Conditions the study is for
- Peanut Allergic Subjects, Peanut Allergies, Peanut Hypersensitivity
- What is being tested?
- Oral immunotherapy with peanut
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 56 participants
- Where
- 5 sitesDenmark
- Study dates
- Oct 2026to Oct 2031
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 to 48 months
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Aged 6 to 48 months
- Peanut allergy confirmed at an oral food challenge
- Reaction threshold below 300 mg of peanut protein at the oral food challenge
- Specific IgE to peanut > 0.35 kU/L
- Family motivated for oral immunotherapy following shared decision-making using a decision aid
Who cannot join
- Uncontrolled asthma, eczema, rhinoconjunctivitis, urticaria, or eosinophilic esophagitis
- Treatment with biologic or immunosuppressive medication
- Tree nut allergy requiring avoidance of trace amounts
- Non-Danish-speaking families
- Anticipated non-adherent families
Trial locations and contacts
5 sites in 1 country. Contact the study team or a site near you to ask about taking part.
5 sites in 1 country
Denmark5 sites
The Danish Center of Pediatric Pulmonology and Allergology, Department of Pediatrics and Adolescent Medicine, Aarhus University Hospital
Aarhus
Laura O Kettner, +45 51703229, lauchr@rm.dk
Laura O Kettner
Regional Hospital Gødstrup
Gødstrup
Anette Flugt, +45 78430355, aneflu@rm.dk
Anette Flugt
Regional Hospital Kolding
Kolding
Signe V Vahlkvist, +45 76363341, Signe.Vahlkvist@rsyd.dk
Signe V Vahlkvist
Regional Hospital Randers
Randers
Lotte Abildgaard, LOTABI@rm.dk
Lotte Abildgaard
Regional Hospital Viborg
Viborg
Birgitte T Petersen, Birgitte.Petersen@midt.rm.dk
Birgitte T Petersen
About this study
Official title: Oral Immunotherapy for Children With Peanut Allergy: A Randomized Controlled Trial
This clinical trial aims to investigate if oral immunotherapy can help children with peanut allergy tolerate peanut.
Children aged 6 months to 4 years can take part in the trial.
Read more
Main question: What percentage of children can tolerate peanut after oral immunotherapy, compared with children who avoid peanut?
Children are assigned to these two groups by chance.
Children receiving oral immunotherapy will:
- Take a small, increasing amount of peanut daily for 1-1.5 years
- Attend clinic or online visits each time the dose is increased
- Record missed doses
All children will:
- Provide blood samples to measure allergy-related markers
- Undergo an oral food challenge with peanut after 1-1.5 years to assess how much they can tolerate
- Report allergic reactions (parent-reported)
- Complete questionnaires (parent-reported)
- Participate in an end-of-study telephone interview with an allergy nurse (parent-reported)
- Conditions
- Peanut Allergic Subjects, Peanut Allergies, Peanut Hypersensitivity, Food Allergy Peanut, Food Allergy in Children, Food Allergies
- Being tested
- Oral immunotherapy with peanut
- Keywords
- Oral immunotherapy, OIT, Desensitization
- Medical subject headings
- Peanut Hypersensitivity, Food Hypersensitivity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Oral immunotherapy with peanutOther
Oral immunotherapy with peanut for 1-1.5 years
| Study group | Role | What they receive |
|---|---|---|
| Oral immunotherapy | Experimental | Children randomized to oral immunotherapy will ingest a daily dose of peanut. Dose escalation will be performed approximately every two weeks at the allergy clinic or via online consultations. After approximately 6 months, a maintenance dose of 300 mg food protein will be reached and continued daily for 6-12 months. Receives: Other: Oral immunotherapy with peanut |
| Avoidance | No intervention | Children randomized to avoidance will receive standard care for peanut allergy, namely avoidance of peanut. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Tolerance to peanut (4000 mg)
Proportion of children who tolerate a cumulative dose of 4000 mg of peanut protein at an oral food challenge
Measured: 1-1.5 years after enrollment
Secondary outcomes (8)
Tolerance to peanut (1000 mg)
Proportion of children who tolerate a cumulative dose of 1000 mg of peanut protein at an oral food challenge
Measured: 1-1.5 years after enrollment
Eliciting dose
Change in cumulative eliciting dose at an oral food challenge (mg peanut protein)
Measured: At enrollment and 1-1.5 years after enrollment
Allergic reactions
Proportion of children experiencing allergic reactions to peanut outside the oral food challenge, the number of reactions per child, and the severity of the reactions (World Allergy Organization grading system, grade 1-5; higher grades indicate more severe reactions)
Measured: 6 months, 1-1.5 years, and 2-2.5 years after enrollment
Use of adrenaline auto-injector
Proportion of children for whom an adrenaline auto-injector was used due to allergic reactions to peanut outside the oral food challenge, and the number of uses per child
Measured: 6 months, 1-1.5 years, and 2-2.5 years after enrollment
Severity of allergic reactions at the oral food challenge according to the World Allergy Organization Grading System
Severity of allergic reactions to peanut at the oral food challenge, graded by the World Allergy Organization grading system (grade 1-5; higher grades indicate more severe reactions)
Measured: 1-1.5 years after enrollment
Parental food allergy-related quality of life
Changes in quality of life scores measured by the Food Allergy Quality of Life - Parental Burden Questionnaire (FAQL-PB). Total scores range from 0 to 102, with higher scores indicating worse food allergy-related quality of life
Measured: At enrollment, 1-1.5 years, and 2-2.5 years after enrollment
Parental food allergy-related anxiety
Changes in anxiety scores measured by the Impairment Measure for Parental Food Allergy-Associated Anxiety and Coping Tool (IMPAACT). Total scores range from 0 to 196. Subscale scores are also reported: Cognitive subscale (range 9 to 63), Behavioral subscale (range 9 to 63), Anxiety impact (range 8 to 56), and Child coping (range 2 to 14). For all scores, higher values indicate greater food allergy-related burden.
Measured: At enrollment, 1-1.5 years, and 2-2.5 years after enrollment
Changes in specific immunoglobulin E (IgE)
Changes in peanut-specific IgE (kU/L)
Measured: At enrollment, 1-1.5 years, and 2-2.5 years after enrollment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Oct 2026
- Study startOct 2026 (estimated)
- Primary completionOct 2030 (estimated)
- Study completionOct 2031 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Peanut Allergic SubjectsStudies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 56 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Laura Ozer Kettner
- Sponsor type
- University, hospital or other
- Collaborators
- Randers Regional Hospital, Gødstrup Hospital, Viborg Regional Hospital, Kolding Sygehus
- Responsible party
- Sponsor-investigator, Laura Ozer Kettner, Aarhus University Hospital
- Investigators
- Laura O Kettner, MD, PhD, Principal investigator, The Danish Center of Pediatric Pulmonology and Allergology, Aarhus University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07895095
- Sponsor's protocol ID
- 1-10-72-198-25c
- Status last verified
- Oct 2026
- First submitted
- 28 Sep 2026
- Last updated
- 26 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Individual participant data will not be shared due to ethical and data protection considerations
Publications
Turner PJ, Ansotegui IJ, Campbell DE, Cardona V, Carr S, Custovic A, Durham S, Ebisawa M, Geller M, Gonzalez-Estrada A, Greenberger PA, Hossny E, Irani C, Leung ASY, Levin ME, Muraro A, Oppenheimer JJ, Ortega Martell JA, Pouessel G, Rial MJ, Senna G, Tanno LK, Wallace DV, Worm M, Morais-Almeida M; WAO Anaphylaxis Committee and WAO Allergen Immunotherapy Committee. Updated grading system for systemic allergic reactions: Joint Statement of the World Allergy Organization Anaphylaxis Committee and Allergen Immunotherapy Committee. World Allergy Organ J. 2024 Feb 10;17(3):100876. doi: 10.1016/j.waojou.2024.100876. eCollection 2024 Mar.
PubMed 38361745Cohen BL, Noone S, Munoz-Furlong A, Sicherer SH. Development of a questionnaire to measure quality of life in families with a child with food allergy. J Allergy Clin Immunol. 2004 Nov;114(5):1159-63. doi: 10.1016/j.jaci.2004.08.007.
PubMed 15536425To S, Westwell-Roper C, Soller L, Stewart SE, Chan ES. Development of IMPAACT (Impairment Measure for Parental Food Allergy-Associated Anxiety and Coping Tool), a validated tool to screen for food allergy-associated parental anxiety. Ann Allergy Asthma Immunol. 2022 Oct;129(4):451-460.e3. doi: 10.1016/j.anai.2022.02.020. Epub 2022 Mar 4.
PubMed 35248728O'Connor AM. Validation of a decisional conflict scale. Med Decis Making. 1995 Jan-Mar;15(1):25-30. doi: 10.1177/0272989X9501500105.
PubMed 7898294
Study at a glance
From the registry record, last updated by the sponsor on 26 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Oral Immunotherapy for Children With Peanut Allergy: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT07895095
- Acronym / sponsor ID
- 1-10-72-198-25c
- Conditions
- Peanut Allergic Subjects, Peanut Allergies, Peanut Hypersensitivity, Food Allergy Peanut, Food Allergy in Children, Food Allergies
- Keywords
- Oral immunotherapy, OIT, Desensitization
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 56 participants (estimated)
- Lead sponsor
- Laura Ozer KettnerUniversity, hospital or other
- Collaborators
- Randers Regional Hospital, Gødstrup Hospital, Viborg Regional Hospital, Kolding Sygehus
- Study start
- Oct 2026 (estimated)
- Primary completion
- Oct 2030 (estimated)
- Study completion
- Oct 2031 (estimated)
- First posted
- 26 Oct 2026 (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.
This clinical trial aims to investigate if oral immunotherapy can help children with peanut allergy tolerate peanut.
Children aged 6 months to 4 years can take part in the trial.
Main question: What percentage of children can tolerate peanut after oral immunotherapy, compared with children who avoid peanut?
Children are assigned to these two groups by chance.
Children receiving oral immunotherapy will:
- Take a small, increasing amount of peanut daily for 1-1.5 years
- Attend clinic or online visits each time the dose is increased
- Record missed doses
All children will:
- Provide blood samples to measure allergy-related markers
- Undergo an oral food challenge with peanut after 1-1.5 years to assess how much they can tolerate
- Report allergic reactions (parent-reported)
- Complete questionnaires (parent-reported)
- Participate in an end-of-study telephone interview with an allergy nurse (parent-reported)
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Oral immunotherapy | Experimental | Other: Oral immunotherapy with peanutChildren randomized to oral immunotherapy will ingest a daily dose of peanut. Dose escalation will be performed approximately every two weeks at the allergy clinic or via online consultations. After approximately 6 months, a maintenance dose of 300 mg food protein will be reached and continued daily for 6-12 months. |
| Avoidance | No intervention | –Children randomized to avoidance will receive standard care for peanut allergy, namely avoidance of peanut. |
Who may qualify
- Ages
- 6 to 48 months
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (5 listed)
- Aged 6 to 48 months
- Peanut allergy confirmed at an oral food challenge
- Reaction threshold below 300 mg of peanut protein at the oral food challenge
- Specific IgE to peanut > 0.35 kU/L
- Family motivated for oral immunotherapy following shared decision-making using a decision aid
Key exclusion criteria (5 listed)
- Uncontrolled asthma, eczema, rhinoconjunctivitis, urticaria, or eosinophilic esophagitis
- Treatment with biologic or immunosuppressive medication
- Tree nut allergy requiring avoidance of trace amounts
- Non-Danish-speaking families
- Anticipated non-adherent families
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 immunotherapy with peanutOral immunotherapy with peanut for 1-1.5 years | Other | Oral immunotherapy |
Primary outcome
Tolerance to peanut (4000 mg)
Time frame: 1-1.5 years after enrollment
Proportion of children who tolerate a cumulative dose of 4000 mg of peanut protein at an oral food challenge
8 secondary outcomes
Tolerance to peanut (1000 mg)
Time frame: 1-1.5 years after enrollment
Eliciting dose
Time frame: At enrollment and 1-1.5 years after enrollment
Allergic reactions
Time frame: 6 months, 1-1.5 years, and 2-2.5 years after enrollment
Use of adrenaline auto-injector
Time frame: 6 months, 1-1.5 years, and 2-2.5 years after enrollment
Severity of allergic reactions at the oral food challenge according to the World Allergy Organization Grading System
Time frame: 1-1.5 years after enrollment
Parental food allergy-related quality of life
Time frame: At enrollment, 1-1.5 years, and 2-2.5 years after enrollment
Parental food allergy-related anxiety
Time frame: At enrollment, 1-1.5 years, and 2-2.5 years after enrollment
Changes in specific immunoglobulin E (IgE)
Time frame: At enrollment, 1-1.5 years, and 2-2.5 years after enrollment
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Oct 2026.
- Background: PubMed 38361745Turner PJ, Ansotegui IJ, Campbell DE, Cardona V, Carr S, Custovic A, Durham S, Ebisawa M, Geller M, Gonzalez-Estrada A, Greenberger PA, Hossny E, Irani C, Leung ASY, Levin ME, Muraro A, Oppenheimer JJ, Ortega Martell JA, Pouessel G, Rial MJ, Senna G, Tanno LK, Wallace DV, Worm M, Morais-Almeida M; WAO Anaphylaxis Committee and WAO Allergen Immunotherapy Committee. Updated grading system for systemic allergic reactions: Joint Statement of the World Allergy Organization Anaphylaxis Committee and Allergen Immunotherapy Committee. World Allergy Organ J. 2024 Feb 10;17(3):100876. doi: 10.1016/j.waojou.2024.100876. eCollection 2024 Mar.
- Background: PubMed 15536425Cohen BL, Noone S, Munoz-Furlong A, Sicherer SH. Development of a questionnaire to measure quality of life in families with a child with food allergy. J Allergy Clin Immunol. 2004 Nov;114(5):1159-63. doi: 10.1016/j.jaci.2004.08.007.
- Background: PubMed 35248728To S, Westwell-Roper C, Soller L, Stewart SE, Chan ES. Development of IMPAACT (Impairment Measure for Parental Food Allergy-Associated Anxiety and Coping Tool), a validated tool to screen for food allergy-associated parental anxiety. Ann Allergy Asthma Immunol. 2022 Oct;129(4):451-460.e3. doi: 10.1016/j.anai.2022.02.020. Epub 2022 Mar 4.
- Background: PubMed 7898294O'Connor AM. Validation of a decisional conflict scale. Med Decis Making. 1995 Jan-Mar;15(1):25-30. doi: 10.1177/0272989X9501500105.
- Individual participant dataSharing planned: No. Individual participant data will not be shared due to ethical and data protection considerations
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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.
Laura O Kettner, MD, PhD principal investigator
The Danish Center of Pediatric Pulmonology and Allergology, Aarhus University Hospital
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Oral immunotherapy with peanut in people with Peanut Allergic Subjects and Peanut Allergies, run by Laura Ozer Kettner at 5 sites in Denmark.
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 5 inclusion and 5 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: opening soon, as of the sponsor's last update on 26 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in Denmark. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Laura O Kettner, MD, PhD (+45 51703229, lauchr@rm.dk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Tolerance to peanut (4000 mg) (time frame: 1-1.5 years after enrollment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07895095, which also lists 4 linked publications.
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 Oct 2026.