Immunotherapy Clinical Trial
Official title:
Comparison Efficacy Between Two Different Frequency of Maintenance Dose-oral Immunotherapy for Children With Wheat Allergy
Oral immunotherapy(OIT) is effective in desensitized food allergy. OIT protocols are not standardized, and a wide heterogeneity exists in the literature . So the purpose of our study is to compare short term unresponsiveness rate between once daily dose and four times/week dose during one year maintenance phase of wheat OIT
Status | Recruiting |
Enrollment | 64 |
Est. completion date | March 22, 2027 |
Est. primary completion date | March 22, 2027 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 5 Years to 18 Years |
Eligibility | Inclusion Criteria: - Age 5-18 years old - Children aged 5-18 years with history of IgE mediated wheat allergy and positive OFC test - Reach target maintenance dose of wheat OIT and ongoing to maintenance phase of wheat OIT Exclusion Criteria: - Patient with low dose OIT protocol - Patients with uncontrolled atopic dermatitis, uncontrolled asthma, or any chronic disease; - Patients who had been treated with some other immunotherapy (eg, SLIT, another OIT) or biologic therapy (eg, Omalizumab) - Patients with a developmental problem or mental disorder - Active eosinophilic gastrointestinal disease in the past 2 years - Use of b-blockers (oral), angiotensin-converting enzyme inhibitors, angiotensin-receptor blockers, or calcium-channel blockers - Pregnancy or lactation - Patient who could not visit clinic as protocol |
Country | Name | City | State |
---|---|---|---|
Thailand | Siriraj Hospital | Bangkoknoi | Bangkok |
Lead Sponsor | Collaborator |
---|---|
Mahidol University |
Thailand,
Pajno GB, Fernandez-Rivas M, Arasi S, Roberts G, Akdis CA, Alvaro-Lozano M, Beyer K, Bindslev-Jensen C, Burks W, Ebisawa M, Eigenmann P, Knol E, Nadeau KC, Poulsen LK, van Ree R, Santos AF, du Toit G, Dhami S, Nurmatov U, Boloh Y, Makela M, O'Mahony L, Papadopoulos N, Sackesen C, Agache I, Angier E, Halken S, Jutel M, Lau S, Pfaar O, Ryan D, Sturm G, Varga EM, van Wijk RG, Sheikh A, Muraro A; EAACI Allergen Immunotherapy Guidelines Group. EAACI Guidelines on allergen immunotherapy: IgE-mediated food allergy. Allergy. 2018 Apr;73(4):799-815. doi: 10.1111/all.13319. Epub 2017 Dec 5. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Short term unresponsiveness rate | Short term unresponsiveness rate between once daily dose and four times/week dose .during maintenance phase of wheat OIT.
Short term unresponsiveness means patients who pass the oral food challenge test after stopping oral immunotherapy for a short period |
13 months | |
Secondary | Specific IgE to wheat | Specific IgE to wheat | 13 months | |
Secondary | Specific IgG4 to wheat | Specific IgG4 to wheat | 13 months | |
Secondary | Changing in Body weight | Changing in Body weight in kilograms | 13 months | |
Secondary | Compliance | Compliance of wheat ingestion (group A: every day, groupB: 4 days/weeks). Compliance can be calculated by dividing the number of days on which wheat is actually ingested by the total number of days prescribed for wheat consumption. | 12 months | |
Secondary | Adverse reactions | Adverse reaction during treatment will be recorded by using WAO systemic allergic reaction grading system | 13 months | |
Secondary | Quality of life by using FAQLQ-PF | Quality of life before and after enrollment by using FAQLQ-PF | 13 months |
Status | Clinical Trial | Phase | |
---|---|---|---|
Recruiting |
NCT05848011 -
A Study of Lorigerlimab With Docetaxel or Docetaxel Alone in Participants With Metastatic Castration-Resistant Prostate Cancer
|
Phase 2 | |
Recruiting |
NCT05161572 -
Perioperative Chemoimmunotherapy With/Without Preoperative Chemoradiation for Locally Advanced Gastric Cancer
|
Phase 2 | |
Recruiting |
NCT06165900 -
Stereotactic Radiotherapy Combined With Adebrelimab and TCb (Nab-paclitaxel + Carboplatin) in Neoadjuvant Treatment of TNBC
|
Phase 2 | |
Recruiting |
NCT06120127 -
Postoperative Chemotherapy With/Without Radiotherapy and Immunotherapy for Colorectal Liver Metastases With High Risk of Locally Recurrence
|
Phase 2 | |
Recruiting |
NCT06262581 -
Neoadjuvant Tisleizumab(BGB-A317) for dMMR/MSI-H Non-late Stage CRC Patients Before Surgery
|
Phase 2 | |
Recruiting |
NCT05176002 -
Camrelizumab in Combination With Radiotherapy for Neoadjuvant Esophageal Carcinoma.
|
Phase 1/Phase 2 | |
Not yet recruiting |
NCT05909137 -
Omitting Clinical Target Volume in Radical Treatment of Unresectable Stage III Non-small Cell Lung Cancer
|
||
Recruiting |
NCT04500990 -
MRI DWI None-Gaussian Model Predicting Early Response to Immunotherapy in Digestive System Malignancies: a Prospective Observational Study
|
||
Not yet recruiting |
NCT04372732 -
Serum Autoantibodies in Predicting the Efficacy of Anti-PD-1 Treatment in Patients With Advanced NSCLC
|
||
Completed |
NCT02692976 -
Natural Dendritic Cells for Immunotherapy of Chemo-naive Metastatic Castration-resistant Prostate Cancer Patients
|
Phase 2 | |
Completed |
NCT03763630 -
MAPS & ITEC Cohorts: 6-8 Years Follow-up
|
Phase 2 | |
Not yet recruiting |
NCT06012318 -
Dynamic Follow-up of Symptoms Based on Patient-reported Outcomes in Immunotherapy for Esophageal Cancer: a Prospective Multicentre Cohort Study (SPRING)
|
||
Not yet recruiting |
NCT05479240 -
Neoadjuvant Chemoradiotherapy Combined With Tislelizumab in the Treatment of Locally Advanced Rectal Cancer
|
Phase 2 | |
Recruiting |
NCT04711330 -
Response and Toxicity Prediction by Microbiome Analysis After Concurrent Chemoradiotherapy
|
||
Recruiting |
NCT05515796 -
Multi-omics Sequencing in Neoadjuvant Immunotherapy of Gastrointestinal Tumors
|
Phase 2 | |
Recruiting |
NCT03683407 -
Effect of Chemotherapy on TMB in NSCLC
|
||
Recruiting |
NCT03701607 -
Effect of Chemotherapy on PD-L1 in NSCLC
|
||
Completed |
NCT03357861 -
Cancer Patients Treated With Immunotherapy in Intensive Care Unit
|
||
Recruiting |
NCT05223088 -
Tislelizumab Combined With Apatinib and Oxaliplatin Plus S1 as Neoadjuvant Therapy for Borrmann IV、Large Borrmann III Type and Bulky N Positive Advanced Gastric Cancer
|
Phase 2 | |
Completed |
NCT05657262 -
Effect of Z Technıque on Pain, Comfort, Symptoms in Ummunotherapy Areas
|
N/A |