Peanut Allergy Clinical Trial
Official title:
A Randomised, Controlled Trial Evaluating the Effectiveness of Probiotic and Peanut Oral Immunotherapy (PPOIT) in Inducing Desensitisation or Remission in Chinese Children With Peanut Allergy Compared With Oral Immunotherapy (OIT) Alone and With Placebo
Verified date | February 2024 |
Source | Chinese University of Hong Kong |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
At present there is no cure for food allergy. People with a food allergy need to avoid the food they are allergic to in order to stay safe. However we know that accidental exposure is common. Researchers have begun to look at the effectiveness of 'oral immunotherapy' as a treatment for food allergy but results have been mixed. This study is a randomized controlled trial to evaluate the effectiveness of Probiotic and Peanut Oral Immunotherapy (PPOIT) in inducing tolerance in children with peanut allergy compared with Oral Immunotherapy (OIT) alone and with Placebo. Children will take increasing doses of peanut protein and a set amount of probiotic until a total of 18 months treatment is completed. Children will be tested for peanut allergy at the start of the study, at the end of PPOIT treatment T1 (18 months) and T2 (8 weeks) and T3 (1year) after treatment.
Status | Active, not recruiting |
Enrollment | 90 |
Est. completion date | December 31, 2024 |
Est. primary completion date | September 30, 2024 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 1 Year to 17 Years |
Eligibility | Inclusion Criteria: Subjects are eligible if they meet all of the following criteria - Aged between 1 year and 17 years of age; - >=7kg (the weight considered safe for administration of adrenaline autoinjector (e.g. Jext); - Ethnic Chinese; and - Confirmed diagnosis of peanut allergy as defined by a failed double-blind placebo-controlled food challenge (DBPCFC) with peanut and a serum peanut-specific IgE level of at least 0.35 kUA (allergen-specific unit) per liter according to ImmunoCAP (Thermo Fisher Scientific) at screening. Exclusion Criteria: Subjects are not eligible if they meet any of the following criteria - History of severe anaphylaxis (as defined by persistent hypotension, collapse, loss of consciousness, persistent hypoxia or ever needing >3 doses of intramuscular adrenaline or an intravenous adrenaline infusion for management of an allergic reaction); - Severe anaphylaxis during the study entry DBPCFC (defined as persistent hypotension, collapse, loss of consciousness, persistent hypoxia, or requiring >3 doses of intramuscular adrenaline or an intravenous adrenaline infusion for management of an allergic reaction); - FEV1 <85% at rest and FEV1/FVC = 85% at rest or ongoing chronic persistent asthma (as per Australian Asthma Foundation guidelines); - Underlying medical conditions (e.g. cardiac disease) that increase the risks for anaphylaxis; - Use of beta-blockers, and ACE inhibitors; - Inflammatory intestinal conditions, indwelling catheters, gastrostomies, immunocompromised states, post-cardiac and/or gastrointestinal tract surgery, critically-ill or other conditions that may increase the risks of probiotic associated sepsis; - Already taking probiotic supplements or foods containing probiotics within the past month; - Reacting to the placebo component during the study entry DBPCFC; - Have received other food immunotherapy treatment in the preceding 12 months; - History of suspected or biopsy-confirmed eosinophilic esophagitis (EoE); - Currently taking immunomodulatory therapy (including allergen immunotherapy); - Past or current major illness that in the opinion of the Site Investigator may affect the subject's ability to participate in the study e.g. increased risk to the participant; - Subjects who in the opinion of the Site Investigator are unable to follow the protocol; - Another family member already enrolled in the trial (to maintain safety and blinding); or - Non-English and non-Chinese speaking participants and their families. NOTE: participants with other food allergies are NOT excluded from participating in this trial. |
Country | Name | City | State |
---|---|---|---|
Hong Kong | Department of Paediatrics and Adolescent Medicine, Hong Kong Children's Hospital | Hong Kong | |
Hong Kong | Department of Paediatrics and Adolescent Medicine, Princess Margaret Hospital | Hong Kong | |
Hong Kong | Department of Paediatrics, Prince of Wales Hospital, The Chinese University of Hong Kong | Hong Kong | |
Hong Kong | Department of Paediatrics, Queen Elizabeth Hospital | Hong Kong |
Lead Sponsor | Collaborator |
---|---|
Chinese University of Hong Kong |
Hong Kong,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Proportion of participants with 8-week sustained unresponsiveness (passed T1 and T2 challenges) in PPOIT vs placebo | T2 - 8 weeks after final day of maintenance treatment | ||
Secondary | Proportion of participants with 8-week sustained unresponsiveness (passed T1 and T2 challenges) in PPOIT vs peanut OIT. | T2 - 8 weeks after final day of maintenance treatment | ||
Secondary | Proportion of participants who achieve full desensitisation (passed T1 challenge) in: (i) PPOIT vs placebo and (ii) PPOIT vs OIT; and (iii) OIT vs placebo. | T1 - One Day after final day of maintenance treatment | ||
Secondary | The cumulative dose tolerated during the T1 challenge in: (i) PPOIT vs placebo and (ii) PPOIT vs OIT; and (iii) OIT vs placebo. | Cumulative doses below the reaction-eliciting dose if there is a reaction; or total cumulative challenge dose if there is no reaction | T1 - One Day after final day of maintenance treatment | |
Secondary | Peanut SPT wheal size and peanut and peanut component (Ara h 1, Ara h 2, Ara h 3) sIgE and sIgG4 levels in: (i) PPOIT vs placebo; (ii) PPOIT vs OIT; and (iii) OIT vs placebo and their correlation with sustained unresponsiveness. | At 12 months of treatment; T1 - One Day after final day of maintenance treatment. T2 - 8 weeks after final day of maintenance treatment | ||
Secondary | Exposure-adjusted incidence rate and severity of treatment emergent adverse events (TEAEs) in (i) PPOIT vs placebo; and (ii) PPOIT vs OIT; and (iii) OIT vs placebo groups. | TEAEs will be collected until T2 - 8 weeks after final day of maintenance. |
Status | Clinical Trial | Phase | |
---|---|---|---|
Recruiting |
NCT05667610 -
Immune-supportive Diet and Gut Permeability in Allergic Children
|
N/A | |
Recruiting |
NCT05440643 -
Peanut Sublingual Immunotherapy (SLIT)-Tablet for Treatment of Peanut Allergy
|
Phase 1 | |
Terminated |
NCT03849079 -
Validation of the HYPONUT Product
|
N/A | |
Completed |
NCT02979600 -
Clinical and Biological Efficacy of Peanut Oral Immunotherapy
|
N/A | |
Completed |
NCT01955109 -
Follow-up of the VIPES Study to Evaluate Efficacy and Safety of Viaskin Peanut in Adults and Children
|
Phase 2 | |
Completed |
NCT01950533 -
The Utility of Food-Specific IgE Measured With the IMMULITE 2000 Assay to Predict Symptomatic Food Allergy
|
||
Recruiting |
NCT04415593 -
High and Low Dose Oral Peanut Immunotherapy - Comparison of Efficacy and Safety
|
N/A | |
Active, not recruiting |
NCT04511494 -
Oral Immunotherapy for Young Children With Peanut Allergy - Small Children OIT
|
N/A | |
Active, not recruiting |
NCT04887441 -
Allergology: Information, Data and Knowledge Organization
|
||
Active, not recruiting |
NCT04881773 -
Oral Low Doses Tolerance INduction Study for Peanuts
|
||
Completed |
NCT03682770 -
Study in Pediatric Subjects With Peanut Allergy to Evaluate Efficacy and Safety of Dupilumab as Adjunct to AR101 (Peanut Oral Immunotherapy)
|
Phase 2 | |
Terminated |
NCT03703791 -
Real World, Open Label, QOL Assessment of Peanut Immunotherapy AR101 in Children and Adolescents
|
Phase 3 | |
Completed |
NCT02916446 -
Safety Study of Viaskin Peanut to Treat Peanut Allergy
|
Phase 3 | |
Active, not recruiting |
NCT02402231 -
Treatment of Severe Peanut Allergy With Xolair (Omalizumab) and Oral Immunotherapy
|
Phase 2 | |
Completed |
NCT03337542 -
AR101 Real-World Open-Label Extension Study
|
Phase 3 | |
Recruiting |
NCT05476497 -
Phase I Trial to Evaluate VLP Peanut in Healthy and Peanut Allergic Subjects
|
Phase 1 | |
Completed |
NCT03648320 -
The Grown Up Peanut Immunotherapy Study
|
N/A | |
Completed |
NCT03292484 -
Longer-term Study of AR101 in Subjects Who Participated in a Prior AR101 Study (ARC008)
|
Phase 3 | |
Completed |
NCT03852342 -
Reactive Doses and Times During Oral Food Challenge to Peanut
|
||
Recruiting |
NCT05138757 -
Pinpoint Trial: Prebiotics IN Peanut Oral ImmunoTherapy
|
Phase 1/Phase 2 |