Ignite Creation Date:
2024-10-26 @ 3:37 PM
Last Modification Date:
2024-10-26 @ 3:37 PM
Study NCT ID:
NCT06554691
Status:
RECRUITING
Last Update Posted:
None
First Post:
2024-08-12
Brief Title:
Understanding the Immune Systems Role in Tree Nut and Peanut Allergies Key Biomarkers for Diagnosis and Treatment Monitoring and Treatment Targets
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Exploring the Immunological Basis in the Evolution of Tree Nut and Peanut Allergy During Treatment Care for Understanding Markers and Treatment Targets
Status:
RECRUITING
Status Verified Date:
2024-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
Markers4Care
Brief Summary:
Peanut and tree nuts belong to the main elicitors of pediatric food allergy and are the main cause of near fatal reactions in children requiring emergency management Oral immunotherapy has emerged as an alternative treatment option for the management of food allergies to enhance patients safety and quality of life Monitoring if the therapy is working relies on oral food challenges during the course of treatment There is a clear need for reliable biomarkers that are reflective of the clinical progression during oral food challenges and during immunotherapy that would help with patient stratification and possibly for personalized treatment approaches in the future
The aim of this study is to measure immune parameters in the blood of nut-allergic participants during oral food challenges and during the course of oral immunotherapy
The main questions the study aims to answer are
1 Identify immune markers that correlate with clinical reactivity
2 Identify immune changes and markers that correlate with immunotherapy outcome
Researchers will compare these immune parameters between nut-allergic participants on oral immunotherapy and with nut-allergic participants on avoidance diet Additionally we will also compare the immune parameters of these nut-allergic participants with those healthy adults
The aim of this study is to measure immune parameters in the blood of nut-allergic participants during oral food challenges and during the course of oral immunotherapy
The main questions the study aims to answer are
1 Identify immune markers that correlate with clinical reactivity
2 Identify immune changes and markers that correlate with immunotherapy outcome
Researchers will compare these immune parameters between nut-allergic participants on oral immunotherapy and with nut-allergic participants on avoidance diet Additionally we will also compare the immune parameters of these nut-allergic participants with those healthy adults
Detailed Description:
Background The prevalence of peanut together with tree nut allergies have increase over the years and accounts for most of the life-threatening reactions even to minute doses of the allergen Consequently peanut and tree-nut allergies cause significant physical and mental burden to patients and their caretakers due to anxiety and fear of anaphylaxis from accidental exposures stress from following a strict elimination diet lack of proactive management plan and due to the low probability of natural recovery of such allergies For decades the management relied on a strict avoidance of the culprit foods Oral immune therapy OIT is a ground breaking alternative modality to strict avoidance diets OIT consist of gradual introduction of low doses of the implicated food allergen with the aim to modulate the patients immune response and help build immunological and clinical tolerance Though OIT has its strong advantages the clinical outcome is variable among the patients Therefore there is a clear need for reliable ex-vivo biomarkers that are reflective of the clinical progression and therapy outcome that could aid with a more accurate patient stratification for personalized treatment approaches in the future
Aims This project aims at measuring immune targets antibodies immune cells and immune mediators in patients blood during oral food challenges OFCs and during the course of standard-of-care oral immunotherapy to identify new immune markers correlating to with the clinical outcome of the treatment The identification of immune modifications during OIT will allow us to endotype patients and possibly aid in unraveling markers of food challenges and therapy progression as well as OIT outcome
Luxembourg partners The Luxembourg Institute of Health LIH Department of Infection and Immunity DII head Prof M Ollert has the scientific project lead Principal Investigator Dr A Kuehn Main clinical partners are Dr F Codreanu-Morel and Dr V Petit-Cordebar from the National Unit of Immunology-Allergology Centre Hospitalier CHL Luxembourg Medical Principal Investigator for healthy controls is Dr Alessia Pochesci MD Clinical and Epidemiological Investigation Center CIEC Luxembourg Institute of Health LIH Luxembourg The Integrated Biobank of Luxembourg IBBL will prepare and store a subset of clinical samples until use Other biological samples are prepared and stored at DII LIH Clinical samples blood sera plasmastool will be analyzed at DII LIH
Project implementation The clinicians at CHL will perform detailed clinical examinations of participants including skin prick test SPT serological analysis for specific IgE and food challenges to the implicated food allergen as per their routine clinical practice at the National Unit of Immunology-Allergology CHL Based on the European Academy of Allergy and Clinical Immunology EAACI guidelines and procedures established at CHL all peanut- and tree-nut-allergic participants eligible for the study will undergo a baseline OFC OFC is adapted from PRACTALL protocol and allergen doses are adjusted according to the clinical reactivity of the patient
For participants eligible for immunotherapy N 30 Peanut-OIT and N30 Tree nut-OIT the OIT is based on the established protocol at the clinic and adapted from the current literature Briefly participant ingest incremental doses of the allergen peanuttree nut at home until they reach a maintenance dose of 300 mg nut-protein in approximately 26 weeks 6 months This initial phase of OIT is termed as the build-up phase This is then followed by continued daily intake of this maintenance dose After a minimum of 12 months of the maintenance phase of OIT participants undergo another final OFC at the hospital to assess for desensitization to peanut or tree nut Participants follow up at the hospital every 6 months ie at end of the build-up phase after 6 months and after 12 months of daily intake of maintenance dose
Participants who are not eligible for OIT N30 peanut and tree-nut allergic and who are on avoidance diet are also followed up every 6 months for 18 months However final OFC will not be done for these participants
The data collection of the study participants is carried out by the medical lead
In addition healthy adults N20 tolerating any type of nut and without any known food allergies will be recruited as controls Dr Alessia Pochesci CIEC LIH is responsible for the data collection from these healthy participants
Blood sample collection
i For OIT group
During the baseline and final OFC blood samples will be collected at the beginning during and at the end of the food challenge in three different vials
During OIT follow-up a one-time blood sample will be collected at the end of the build-up phase and after 6 months of maintenance phase in addition to the routine blood collection during these follow-up visits
ii For avoidance group
During the baseline OFC blood samples will be collected at the beginning during and at the end of the food challenge
During follow-up visits one-time blood sampling will be taken six monthly ie at 6 12 and 18 months after the baseline OFC
iii Healthy Adult participants A one-time blood sampling will be done
Stool sample collection
Stool sample will be collected from nut-allergic participants at baseline and after the completion of a minimum of 18 months of the study duration using commercial at-home stool sampling kits Participants receive a collection kit containing special sampling tubes accessories and instructions
Collected clinical samples will be pseudonymized at the clinical centers A synonym list containing the information on the identify of the participants recruited and their corresponding pseudonym will be available at the clinical center only medical investigators Personal data is protected under the regulation EU 2016679 of 27 April 2016 on the protection of individuals with regard to the processing of personal data GDPR and the law of 1 August 2018 on the organization of the National Data Protection Commission and the General Data Protection Act
Aims This project aims at measuring immune targets antibodies immune cells and immune mediators in patients blood during oral food challenges OFCs and during the course of standard-of-care oral immunotherapy to identify new immune markers correlating to with the clinical outcome of the treatment The identification of immune modifications during OIT will allow us to endotype patients and possibly aid in unraveling markers of food challenges and therapy progression as well as OIT outcome
Luxembourg partners The Luxembourg Institute of Health LIH Department of Infection and Immunity DII head Prof M Ollert has the scientific project lead Principal Investigator Dr A Kuehn Main clinical partners are Dr F Codreanu-Morel and Dr V Petit-Cordebar from the National Unit of Immunology-Allergology Centre Hospitalier CHL Luxembourg Medical Principal Investigator for healthy controls is Dr Alessia Pochesci MD Clinical and Epidemiological Investigation Center CIEC Luxembourg Institute of Health LIH Luxembourg The Integrated Biobank of Luxembourg IBBL will prepare and store a subset of clinical samples until use Other biological samples are prepared and stored at DII LIH Clinical samples blood sera plasmastool will be analyzed at DII LIH
Project implementation The clinicians at CHL will perform detailed clinical examinations of participants including skin prick test SPT serological analysis for specific IgE and food challenges to the implicated food allergen as per their routine clinical practice at the National Unit of Immunology-Allergology CHL Based on the European Academy of Allergy and Clinical Immunology EAACI guidelines and procedures established at CHL all peanut- and tree-nut-allergic participants eligible for the study will undergo a baseline OFC OFC is adapted from PRACTALL protocol and allergen doses are adjusted according to the clinical reactivity of the patient
For participants eligible for immunotherapy N 30 Peanut-OIT and N30 Tree nut-OIT the OIT is based on the established protocol at the clinic and adapted from the current literature Briefly participant ingest incremental doses of the allergen peanuttree nut at home until they reach a maintenance dose of 300 mg nut-protein in approximately 26 weeks 6 months This initial phase of OIT is termed as the build-up phase This is then followed by continued daily intake of this maintenance dose After a minimum of 12 months of the maintenance phase of OIT participants undergo another final OFC at the hospital to assess for desensitization to peanut or tree nut Participants follow up at the hospital every 6 months ie at end of the build-up phase after 6 months and after 12 months of daily intake of maintenance dose
Participants who are not eligible for OIT N30 peanut and tree-nut allergic and who are on avoidance diet are also followed up every 6 months for 18 months However final OFC will not be done for these participants
The data collection of the study participants is carried out by the medical lead
In addition healthy adults N20 tolerating any type of nut and without any known food allergies will be recruited as controls Dr Alessia Pochesci CIEC LIH is responsible for the data collection from these healthy participants
Blood sample collection
i For OIT group
During the baseline and final OFC blood samples will be collected at the beginning during and at the end of the food challenge in three different vials
During OIT follow-up a one-time blood sample will be collected at the end of the build-up phase and after 6 months of maintenance phase in addition to the routine blood collection during these follow-up visits
ii For avoidance group
During the baseline OFC blood samples will be collected at the beginning during and at the end of the food challenge
During follow-up visits one-time blood sampling will be taken six monthly ie at 6 12 and 18 months after the baseline OFC
iii Healthy Adult participants A one-time blood sampling will be done
Stool sample collection
Stool sample will be collected from nut-allergic participants at baseline and after the completion of a minimum of 18 months of the study duration using commercial at-home stool sampling kits Participants receive a collection kit containing special sampling tubes accessories and instructions
Collected clinical samples will be pseudonymized at the clinical centers A synonym list containing the information on the identify of the participants recruited and their corresponding pseudonym will be available at the clinical center only medical investigators Personal data is protected under the regulation EU 2016679 of 27 April 2016 on the protection of individuals with regard to the processing of personal data GDPR and the law of 1 August 2018 on the organization of the National Data Protection Commission and the General Data Protection Act
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None