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Oral Immunotherapy for Young Children With Peanut Allergy - Small Children OIT (SmaChO)

Primary Purpose

Peanut Allergy

Status
Active
Phase
Not Applicable
Locations
Sweden
Study Type
Interventional
Intervention
Peanut (bamba)
Sponsored by
Karolinska Institutet
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Peanut Allergy focused on measuring Peanut Hypersensitivity, Immunotherapy, Child preschool, Arachis

Eligibility Criteria

1 Year - 3 Years (Child)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Children 1 - <4 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

Exclusion Criteria:

  • 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

Sites / Locations

  • Forskningsenheten Södersjukhuset AB

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Active Comparator

No Intervention

No Intervention

No Intervention

Arm Label

OIT peanut

Peanut avoidance

Healthy controls

Children not reacting at the baseline peanut challenge

Arm Description

Children with peanut allergy receiving peanut OIT. Peanut challenge are done before randomization and one and three years after inclusion. n=50 patients

Children with peanut allergy not undergoing OIT peanut. Peanut challenge are done Before randomization and one and three years after inclusion. n=25 patients

Control Group with non-allergic, age-matched children. No challenges are performed in this group. n=30 patients

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

Outcomes

Primary Outcome Measures

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 weeks of peanut avoidance. Measured at a peanut challenge

Secondary Outcome Measures

Adverse events during OIT treatment
Adverse events among peanut allergic children with OIT treatment
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.
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).
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.
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
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

Full Information

First Posted
May 11, 2020
Last Updated
September 25, 2023
Sponsor
Karolinska Institutet
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1. Study Identification

Unique Protocol Identification Number
NCT04511494
Brief Title
Oral Immunotherapy for Young Children With Peanut Allergy - Small Children OIT
Acronym
SmaChO
Official Title
Oral Immunotherapy for Young Children With Peanut Allergy - Small Children OIT (SmaChO)
Study Type
Interventional

2. Study Status

Record Verification Date
September 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
September 1, 2020 (Actual)
Primary Completion Date
August 2025 (Anticipated)
Study Completion Date
December 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Karolinska Institutet

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
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 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 healthy controls: 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 challenge 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=X 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 identified through the day surgery at Astrid Lindgren's Children's 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+4 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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Peanut Allergy
Keywords
Peanut Hypersensitivity, Immunotherapy, Child preschool, Arachis

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigator
Masking Description
Blinded randomisation process after a positive baseline peanut challenge (for both participants, care provider and investigator) by opaque envelops. After the child is randomised to treatment or avoidance, everyone (particpant, care provider and investigator) know if the child is in the treatment or avoidance group.
Allocation
Randomized
Enrollment
114 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
OIT peanut
Arm Type
Active Comparator
Arm Description
Children with peanut allergy receiving peanut OIT. Peanut challenge are done before randomization and one and three years after inclusion. n=50 patients
Arm Title
Peanut avoidance
Arm Type
No Intervention
Arm Description
Children with peanut allergy not undergoing OIT peanut. Peanut challenge are done Before randomization and one and three years after inclusion. n=25 patients
Arm Title
Healthy controls
Arm Type
No Intervention
Arm Description
Control Group with non-allergic, age-matched children. No challenges are performed in this group. n=30 patients
Arm Title
Children not reacting at the baseline peanut challenge
Arm Type
No Intervention
Arm Description
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
Intervention Type
Dietary Supplement
Intervention Name(s)
Peanut (bamba)
Intervention Description
OIT peanut with slow-updosing for 40-60 weeks followed by maintenance. 3 years treatment.
Primary Outcome Measure Information:
Title
Sustained unresponsiveness to 750 mg peanut protein
Description
Sustained unresponsiveness to 750 mg peanut protein (cumulative dose) at a peanut challenge after 3 years of OIT and 4 weeks of peanut avoidance. Measured at a peanut challenge
Time Frame
3 years and 4 weeks
Secondary Outcome Measure Information:
Title
Adverse events during OIT treatment
Description
Adverse events among peanut allergic children with OIT treatment
Time Frame
3 years
Title
Quality of Life Before, during and after OIT peanut
Description
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.
Time Frame
3 years
Title
Intestinal microbiome
Description
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).
Time Frame
3 years
Title
Immunological biomarkers
Description
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.
Time Frame
3 years
Title
Tolerance to peanut protein at a challenge after 3 years
Description
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
Time Frame
3 years
Title
Tolerance to peanut protein at a challenge after 1 year
Description
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
Time Frame
1 year

10. Eligibility

Sex
All
Minimum Age & Unit of Time
1 Year
Maximum Age & Unit of Time
3 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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 Exclusion Criteria: 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Anna Asarnoj
Organizational Affiliation
Karolinska Institutet
Official's Role
Principal Investigator
Facility Information:
Facility Name
Forskningsenheten Södersjukhuset AB
City
Stockholm
Country
Sweden

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Oral Immunotherapy for Young Children With Peanut Allergy - Small Children OIT

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