NCT04511494

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:

  1. 1.Peanut OIT with slow up-dosing (40-60 weeks) up to a maintenance dose of 285 mg daily oral peanut protein or
  2. 2.Control group with peanut allergic children who do not undergo OIT.
  3. 3.In addition, a group of healthy children without allergic diseases will be included in the study.

Trial Health

55
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
114

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Sep 2020

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
active not recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 11, 2020

Completed
3 months until next milestone

First Posted

Study publicly available on registry

August 13, 2020

Completed
19 days until next milestone

Study Start

First participant enrolled

September 1, 2020

Completed
4.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2025

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2025

Completed
Last Updated

June 4, 2025

Status Verified

May 1, 2025

Enrollment Period

4.9 years

First QC Date

May 11, 2020

Last Update Submit

May 30, 2025

Conditions

Peanut Allergy

Keywords

Peanut HypersensitivityImmunotherapyChild preschoolArachis

Outcome Measures

Primary Outcomes (1)

  • 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

    3 years and 4-6 weeks

Secondary Outcomes (6)

  • Adverse events during OIT treatment

    3 years

  • Quality of Life Before, during and after OIT peanut

    3 years

  • Intestinal microbiome

    3 years

  • Immunological biomarkers

    3 years

  • Tolerance to peanut protein at a challenge after 3 years

    3 years

  • +1 more secondary outcomes

Study Arms (4)

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

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

Interventions

Peanut (bamba)DIETARY_SUPPLEMENT

OIT peanut with slow-updosing for 40-60 weeks followed by maintenance. 3 years treatment.

OIT peanut

Eligibility Criteria

Age1 Year - 3 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Forskningsenheten Södersjukhuset

Stockholm, Sweden

Location

MeSH Terms

Conditions

Peanut Hypersensitivity

Condition Hierarchy (Ancestors)

Nut and Peanut HypersensitivityFood HypersensitivityHypersensitivity, ImmediateHypersensitivityImmune System Diseases

Study Officials

  • Anna Asarnoj

    Karolinska Institutet

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR
Masking Details
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.
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
PhD student

Study Record Dates

First Submitted

May 11, 2020

First Posted

August 13, 2020

Study Start

September 1, 2020

Primary Completion

August 1, 2025

Study Completion

December 1, 2025

Last Updated

June 4, 2025

Record last verified: 2025-05

Data Sharing

IPD Sharing
Will not share

Locations

SE(1)