Long Term Outcomes Associated With Attainment of Remission Following Oral Immunotherapy to Peanut, Egg and Cow's Milk (LPEM Study)
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 147
- 试验地点
- 1
- 主要终点
- Changes in health-related quality of life (HRQL) scores from baseline to 5-15 years after stopping oral immunotherapy (OIT) in individuals who achieved remission and those who did not, as measured by Food Allergy Quality of Life Questionnaires (FAQLQ).
研究概览
简要总结
The goal of this observational study is to learn about the long-term outcomes of children and young people who underwent an 18-month course of oral immunotherapy (OIT) treatment for peanut, egg or milk allergy. It aims to:
• Compare long-term changes in health-related quality of life (HRQL) at 5-15 years after stopping OIT in participants who achieved remission and those who did not.
Participants will attend a single follow-up visit for:
- A blood test
- Skin prick test (SPT)
- Allergy questionnaires
详细描述
The study population will be made up of participants from four clinical trials: PEAT, PrEMO, PPOIT-001 and PPOIT-002. They are being invited to participate in the LPEM observational study to evaluate the long-term outcomes of OIT.
- PEAT: Egg OIT. These participants are from the PEAT parent study (double-blind placebo-controlled randomized trial of probiotic and egg OIT).
- PrEMO: Egg or Milk OIT. These participants are from the PrEMO parent study (open label study of probiotic and egg and cow's milk OIT).
- PPOIT-001: Peanut OIT. These participants are from the PPOIT-001 parent study (double-blind placebo-controlled randomized trial of probiotic and peanut OIT).
- PPOIT-002: Peanut OIT. These participants are from the PPOIT-002 parent study (open label study of probiotic and peanut OIT).
Participants will have a blood sample taken at the visit to measure their peanut/egg/milk specific immunoglobulin E (sIgE) level. Plasma and peripheral blood mononuclear cells (PBMC) will also be stored for future analysis. A maximum of 50 milliliters (mL) of blood will be collected via venipuncture. If collection of blood via venipuncture is not possible, capillary blood via fingerprick technique will be collected instead (in which case only blood for the sIgE level will be collected, due to volume).
Participants will have a skin prick test completed at the visit to measure their allergy status. The skin prick test will include the following extracts:
- Positive control (histamine)
- Negative control (saline)
- House Dust Mite
- Rye Grass
- Peanut, Egg or Milk (depending on the participant's OIT treatment received in the parent study)
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Previous participant of PEAT, PrEMO, PPOIT-001 or PPOIT-002 parent study
- •Received at least one dose of OIT treatment in the parent study
- •Written informed consent from participant and/or parent/guardian (if below 18 years of age)
排除标准
- •Have any conditions that, in the opinion of the investigator, precludes participation for reason of safety
结局指标
主要结局
Changes in health-related quality of life (HRQL) scores from baseline to 5-15 years after stopping oral immunotherapy (OIT) in individuals who achieved remission and those who did not, as measured by Food Allergy Quality of Life Questionnaires (FAQLQ).
时间窗: A single study visit (approximately 2 hours) will be conducted at 5-15 years after the participant completed OIT in their parent study.
HRQL scores were collected via validated surveys (FAQLQ) during the parent studies (PEAT, PrEMO, PPOIT-001 and PPOIT-002), and will be used again in this study for comparison. Changes in HRQL scores from the parent study (baseline) to 5-15 years after stopping OIT will be compared between the clinical outcome groups (Allergic or Sustained Unresponsiveness (SU)/Remission), as determined by the clinical outcome achieved at the end of treatment in the parent study. HRQL scores (reported as mean and standard deviation) will compare changes between the clinical outcome groups using generalised linear modules, adjusted for continuous variables as well as baseline HRQL scores. If continuous outcomes do not follow normal distribution they will be summarised as median and interquartile ranges (IQR), and comparison between the groups will be performed using the Wilcoxon rank-sum (Mann-Whitney) test.
次要结局
- Changes in HRQL scores from baseline to 5-15 years after stopping OIT in individuals who received OIT and those who received OIT placebo, as measured by FAQLQ.(A single study visit (approximately 2 hours) will be conducted at 5-15 years after the participant completed OIT in their parent study.)
- The incidence and severity of allergic reactions (in the preceding 12 months) at 5-15 years after stopping OIT in individuals who achieved remission and those who did not, as measured by REDCap Allergen Specific Questionnaire.(A single study visit (approximately 2 hours) will be conducted at 5-15 years after the participant completed OIT in their parent study.)
- The incidence and severity of allergic reactions (in the preceding 12 months) at 5-15 years after stopping OIT in individuals who received OIT and those who received OIT placebo, as measured by REDCap Allergen Specific Questionnaire.(A single study visit (approximately 2 hours) will be conducted at 5-15 years after the participant completed OIT in their parent study.)
- Patterns of food ingestion (in the preceding 12 months) at 5-15 years after stopping OIT in individuals who achieved remission and those who did not, as measured by REDCap Allergen Specific Questionnaire.(A single study visit (approximately 2 hours) will be conducted at 5-15 years after the participant completed OIT in their parent study.)
- Changes in immunological markers from baseline to 5-15 years after stopping OIT in individuals who achieved remission and those who did not, as measured by allergen specific immunoglobulin E (sIgE) blood levels.(A single study visit (approximately 2 hours) will be conducted at 5-15 years after the participant completed OIT in their parent study.)
- Changes in immunological markers from baseline to 5-15 years after stopping OIT in individuals who received OIT and those who received OIT placebo, as measured by allergen specific immunoglobulin E (sIgE) blood levels.(A single study visit (approximately 2 hours) will be conducted at 5-15 years after the participant completed OIT in their parent study.)