Peanut AllergySmaChONCT04511494
Oral Immunotherapy for Young Children With Peanut Allergy - Small Children OIT
A study testing Peanut (bamba) in people with Peanut Allergy, run by Karolinska Institutet at 1 site in Sweden.
Trial summary
Open label study with peanut oral immunotherapy (OIT). Peanut allergic children aged 1-3 years of age will be randomized 2:1 to: 1. Peanut OIT with slow up-dosing (40-60 weeks) up to a maintenance dose of 285 mg daily oral peanut protein or 2. Control group with peanut allergic children who do not undergo OIT. 3. Read more about this study
- Who is it for?
- Ages 1 year to 3 years
- Conditions the study is for
- Peanut Allergy
- What is being tested?
- Peanut (bamba)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 114 participants
- Where
- 1 siteSweden
- Study dates
- 1 Sep 2020to Dec 2025
- 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 1 year to 3 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Children 1 - 3 years old at inclusion
- Positive baseline challenge at a maximum of the 250 mg peanut protein-dose with at least one objective symptom, or positive peanut challenge performed in the clinic in a similar way within 1 year from study start.
- IgE-ab to peanut and/or Ara h 2 ≥0.1 kUA/l, analyzed within 12 months from start of study
- Written consent for participation in the study from both Guardians
Who cannot join
- Other serious illness
- Previously life-threatening anaphylaxis (intensive care), regardless of the triggering agent
- A history of eosinophilic esophagitis (EoE), other eosinophilic gastrointestinal disease, severe chronic gastroesophageal reflux disease (GERD), symptoms of dysphagia, unclear recurrent GI disorders
- Participation in another intervention study, if included in intervention Group
- Severe uncontrolled asthma
- Ongoing medication with biological drugs or oral steroids
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Oral Immunotherapy for Young Children With Peanut Allergy - Small Children OIT (SmaChO)
Open label study with peanut oral immunotherapy (OIT). Peanut allergic children aged 1-3 years of age will be randomized 2:1 to:
- Peanut OIT with slow up-dosing (40-60 weeks) up to a maintenance dose of 285 mg daily oral peanut protein or
- Control group with peanut allergic children who do not undergo OIT.
- In addition, a group of healthy children without allergic diseases will be included in the study.
Read more
The primary outcome is tolerance to at least 750 mg peanut protein at a challenge after 3 years and sustained unresponsiveness (i.e. tolerance) to 750 mg peanut protein after 3 years of OIT followed by 4-6 weeks of avoidance.
Efficacy and safety will be compared between group 1 and 2. Group 3 is a control group for analyses of immunological markers.
Read the detailed description
Problem: Today there is no clinically available treatment for peanut allergy. Oral Immunotherapy (OIT) studies have shown promising results, particularly in younger children (<4 years).
Intervention: Peanut OIT in children aged 1-3 years with peanut allergy (clinical symptoms at peanut challenge and IgE >0.1 kU /l to peanut and/or Ara h 2).
Comparison: Three groups are compared. Peanut allergic children are randomized 2:1 to group 1 (active OIT) or group 2 (control). Group 3 consists of age-matched non-allergic children:
Group 1; Children with peanut allergy receiving peanut OIT, slow up-dosing, 40-60 weeks, until the maintenance dose 285 mg peanut protein. Three years' treatment. (n=50 patients)
Group 2; Age-matched children with peanut allergy who do not undergo OIT peanut (peanut avoidance group). Peanut challenges are performed one and three years after inclusion. (n=25 patients)
Group 3; Healthy, non-allergic, age-matched children. No challenges are performed in this group. (n=30 patients)
Group 4; Children not reacting at the baseline peanut challenge (n=9 patients)
Inclusion of study subjects: A review of samples sent to the Karolinska University Laboratory for IgE-ab responses to peanut/Ara h 2 for children in the Stockholm area aged 1-3 years is used for identification of potential participants to whom a letter is sent with information about the study. The families are randomized 2:1 to OIT or control group, group 1 or group 2.
Children without allergies, healthy controls (group 3), will be included from Västerås Hospital.
If children are included in the study but they do not not react at the baseline peanutchallenge, they will not have any intervention (are not eligible to randomisation) and will have a follow-up after 1+3 years (without peanut challenges), group 4.
Outcomes: The primary outcome is defined as sustained unresponsiveness to 750 mg peanut protein (cumulative dose) at an open oral peanut challenge after 3 years of OIT followed by 4-6 weeks of avoidance (group 1 and 2).
Secondary outcomes are adverse events among peanut allergic children with/without OIT treatment (group 1 and 2), and changes in quality of life parameters and immunological markers (group, 1, 2, 3).
- Conditions
- Peanut Allergy
- Being tested
- Peanut (bamba)
- Keywords
- Peanut Hypersensitivity, Immunotherapy, Child preschool, Arachis
- Medical subject headings
- Peanut Hypersensitivity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Peanut (bamba)Dietary supplement
OIT peanut with slow-updosing for 40-60 weeks followed by maintenance. 3 years treatment.
| Study group | Role | What they receive |
|---|---|---|
| OIT peanut | Active comparator | Children with peanut allergy receiving peanut OIT. Peanut challenge are done before randomization and one and three years after inclusion.
n=50 patients Receives: Dietary Supplement: Peanut (bamba) |
| Peanut avoidance | No intervention | Children with peanut allergy not undergoing OIT peanut. Peanut challenge are done Before randomization and one and three years after inclusion. n=25 patients |
| Healthy controls | No intervention | Control Group with non-allergic, age-matched children. No challenges are performed in this group. n=30 patients |
| Children not reacting at the baseline peanut challenge | No intervention | Peanut-allergic children not reacting at the baseline peanut challenge, will not be eligible for randomisation. They will have a clinical visit after 1+3 years. No more challenges in this group. n=X patients |
What is being measured
The primary outcome is the main question the study is designed to answer.
Sustained unresponsiveness to 750 mg peanut protein
Sustained unresponsiveness to 750 mg peanut protein (cumulative dose) at a peanut challenge after 3 years of OIT and 4-6 weeks of peanut avoidance. Measured at a peanut challenge
Measured: 3 years and 4-6 weeks
Secondary outcomes (6)
Adverse events during OIT treatment
Adverse events among peanut allergic children with OIT treatment
Measured: 3 years
Quality of Life Before, during and after OIT peanut
Examine how quality of life, measured with Food Allergy Quality of Life Questionnaire-parental Form (FAQLQ-PF), is affected in families with peanut allergic children undergoing peanut OIT compared to those without peanut OIT. FAQLQ-PF has questions for food-allergy specific QoL with general emotional impact; food anxiety; social and dietary limitations. The FAQLQ-PF has a seven-point scale ranging from 0 (no impact on HRQL) to 6 (extreme impact on HRQL).Overall and domain-specific HRQL scores will be calculated. Higher scores mean a worse outcome and a score of ≥ ±0.5 will be considered clinically relevant.
Measured: 3 years
Intestinal microbiome
The gut microbiome will be investigated with sequencing-based methods to monitor possible changes in the gut microbiota composition and function related to OIT treatment. This will be compared to samples from the non-allergic individuals (reference).
Measured: 3 years
Immunological biomarkers
To study differerent immunological biomarkers (e.g. T-helper cell-population and polarization and IgE levels) before, during and after OIT treatment and compare this to healthy controls. Immunological marker in mononuclear cells in peripheral blood will be analyzed ex vivo with flowcytometri and RNA-sequensingplatforms. Cirkulating immunological factors, e.g. cytokines and chemocines will be analyzed in plasma with ELISA-based methods.Mononuclear cellpopulations in periferal blood will be exposed to different stimuli (such as peanut, anti-C D3/C D28) in vitro, type anf level of reaction in the different cellpopulations will be monitored at mRNA- och protein-level.
Measured: 3 years
Tolerance to peanut protein at a challenge after 3 years
Is OIT peanut with a low dose and slow up dosing strategy in young peanut allergic Children safe and effective? Measured at a peanut challenge
Measured: 3 years
Tolerance to peanut protein at a challenge after 1 year
Is OIT peanut with a low dose and slow up dosing strategy in young peanut allergic children safe and effective? Measured at a peanut challenge
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Aug 2020
- Study start1 Sep 2020
- Primary completionAug 2025 (estimated)
- Study completionDec 2025 (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.
- More trials run by Karolinska InstitutetThe 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 114 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Karolinska Institutet
- Sponsor type
- University, hospital or other
- Collaborators
- Stockholm South General Hospital
- Responsible party
- Principal investigator, Carina Uhl, Karolinska Institutet
- Investigators
- Anna Asarnoj, Principal investigator, Karolinska Institutet
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04511494
- Sponsor's protocol ID
- 2019-04645
- Other IDs
- 2019
- Acronym
- SmaChO
- Status last verified
- May 2025
- First submitted
- 11 May 2020
- Last updated
- 4 Jun 2025
- 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 4 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Oral Immunotherapy for Young Children With Peanut Allergy - Small Children OIT (SmaChO)
- ClinicalTrials.gov ID
- NCT04511494
- Acronym / sponsor ID
- SmaChO / 2019-04645
- Conditions
- Peanut Allergy
- Keywords
- Peanut Hypersensitivity, Immunotherapy, Child preschool, Arachis
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 114 participants (estimated)
- Lead sponsor
- Karolinska InstitutetUniversity, hospital or other
- Collaborators
- Stockholm South General Hospital
- Study start
- 1 Sep 2020 (actual)
- Primary completion
- Aug 2025 (estimated)
- Study completion
- Dec 2025 (estimated)
- First posted
- 13 Aug 2020 (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.
Open label study with peanut oral immunotherapy (OIT). Peanut allergic children aged 1-3 years of age will be randomized 2:1 to:
- Peanut OIT with slow up-dosing (40-60 weeks) up to a maintenance dose of 285 mg daily oral peanut protein or
- Control group with peanut allergic children who do not undergo OIT.
- In addition, a group of healthy children without allergic diseases will be included in the study.
The primary outcome is tolerance to at least 750 mg peanut protein at a challenge after 3 years and sustained unresponsiveness (i.e. tolerance) to 750 mg peanut protein after 3 years of OIT followed by 4-6 weeks of avoidance.
Efficacy and safety will be compared between group 1 and 2. Group 3 is a control group for analyses of immunological markers.
Detailed description
Problem: Today there is no clinically available treatment for peanut allergy. Oral Immunotherapy (OIT) studies have shown promising results, particularly in younger children (<4 years).
Intervention: Peanut OIT in children aged 1-3 years with peanut allergy (clinical symptoms at peanut challenge and IgE >0.1 kU /l to peanut and/or Ara h 2).
Comparison: Three groups are compared. Peanut allergic children are randomized 2:1 to group 1 (active OIT) or group 2 (control). Group 3 consists of age-matched non-allergic children:
Group 1; Children with peanut allergy receiving peanut OIT, slow up-dosing, 40-60 weeks, until the maintenance dose 285 mg peanut protein. Three years' treatment. (n=50 patients)
Group 2; Age-matched children with peanut allergy who do not undergo OIT peanut (peanut avoidance group). Peanut challenges are performed one and three years after inclusion. (n=25 patients)
Group 3; Healthy, non-allergic, age-matched children. No challenges are performed in this group. (n=30 patients)
Group 4; Children not reacting at the baseline peanut challenge (n=9 patients)
Inclusion of study subjects: A review of samples sent to the Karolinska University Laboratory for IgE-ab responses to peanut/Ara h 2 for children in the Stockholm area aged 1-3 years is used for identification of potential participants to whom a letter is sent with information about the study. The families are randomized 2:1 to OIT or control group, group 1 or group 2.
Children without allergies, healthy controls (group 3), will be included from Västerås Hospital.
If children are included in the study but they do not not react at the baseline peanutchallenge, they will not have any intervention (are not eligible to randomisation) and will have a follow-up after 1+3 years (without peanut challenges), group 4.
Outcomes: The primary outcome is defined as sustained unresponsiveness to 750 mg peanut protein (cumulative dose) at an open oral peanut challenge after 3 years of OIT followed by 4-6 weeks of avoidance (group 1 and 2).
Secondary outcomes are adverse events among peanut allergic children with/without OIT treatment (group 1 and 2), and changes in quality of life parameters and immunological markers (group, 1, 2, 3).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| OIT peanut | Active comparator | Dietary Supplement: Peanut (bamba)Children with peanut allergy receiving peanut OIT. Peanut challenge are done before randomization and one and three years after inclusion. n=50 patients |
| Peanut avoidance | No intervention | –Children with peanut allergy not undergoing OIT peanut. Peanut challenge are done Before randomization and one and three years after inclusion. n=25 patients |
| Healthy controls | No intervention | –Control Group with non-allergic, age-matched children. No challenges are performed in this group. n=30 patients |
| Children not reacting at the baseline peanut challenge | No intervention | –Peanut-allergic children not reacting at the baseline peanut challenge, will not be eligible for randomisation. They will have a clinical visit after 1+3 years. No more challenges in this group. n=X patients |
Who may qualify
- Ages
- 1 year to 3 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- Children 1 - 3 years old at inclusion
- Positive baseline challenge at a maximum of the 250 mg peanut protein-dose with at least one objective symptom, or positive peanut challenge performed in the clinic in a similar way within 1 year from study start.
- IgE-ab to peanut and/or Ara h 2 ≥0.1 kUA/l, analyzed within 12 months from start of study
- Written consent for participation in the study from both Guardians
Key exclusion criteria (6 listed)
- Other serious illness
- Previously life-threatening anaphylaxis (intensive care), regardless of the triggering agent
- A history of eosinophilic esophagitis (EoE), other eosinophilic gastrointestinal disease, severe chronic gastroesophageal reflux disease (GERD), symptoms of dysphagia, unclear recurrent GI disorders
- Participation in another intervention study, if included in intervention Group
- Severe uncontrolled asthma
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 |
|---|---|---|
| Peanut (bamba)OIT peanut with slow-updosing for 40-60 weeks followed by maintenance. 3 years treatment. | Dietary supplement | OIT peanut |
Primary outcome
Sustained unresponsiveness to 750 mg peanut protein
Time frame: 3 years and 4-6 weeks
Sustained unresponsiveness to 750 mg peanut protein (cumulative dose) at a peanut challenge after 3 years of OIT and 4-6 weeks of peanut avoidance. Measured at a peanut challenge
6 secondary outcomes
Adverse events during OIT treatment
Time frame: 3 years
Quality of Life Before, during and after OIT peanut
Time frame: 3 years
Intestinal microbiome
Time frame: 3 years
Immunological biomarkers
Time frame: 3 years
Tolerance to peanut protein at a challenge after 3 years
Time frame: 3 years
Tolerance to peanut protein at a challenge after 1 year
Time frame: 1 year
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 4 Jun 2025.
- 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.
Anna Asarnoj principal investigator
Karolinska Institutet
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Peanut (bamba) in people with Peanut Allergy, run by Karolinska Institutet at 1 site in Sweden.
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 4 inclusion and 6 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: under way, not looking for participants, as of the sponsor's last update on 4 Jun 2025. 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 Sweden. 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?
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?
Sustained unresponsiveness to 750 mg peanut protein (time frame: 3 years and 4-6 weeks). 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 4 Jun 2025.