Ignite Creation Date:
2024-05-06 @ 8:12 PM
Last Modification Date:
2024-10-26 @ 3:23 PM
Study NCT ID:
NCT06297083
Status:
WITHDRAWN
Last Update Posted:
2024-05-08
First Post:
2024-02-29
Brief Title:
Analysing HIgh Dose Probiotic Peanut Oral Immunotherapy PPOIT and High Dose Peanut Oral Immunotherapy OIT Versus LOw Dose Peanut OIT for Peanut Allergy
Sponsor:
Murdoch Childrens Research Institute
Organization:
Murdoch Childrens Research Institute
Study Overview
Official Title:
Analysing HIgh Dose Probiotic Peanut Oral Immunotherapy PPOIT and High Dose Peanut Oral Immunotherapy OIT Versus LOw Dose Peanut OIT for Peanut Allergy
Status:
WITHDRAWN
Status Verified Date:
2024-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Delays in manufacturing increased costs of materials manufacturing and logistics identified during trial set up caused the trial budget to exceed the available funds and an inability to complete the study within required grant timelines
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
HILO
Brief Summary:
This study will compare the effectiveness of three different treatments to treat peanut allergy
Detailed Description:
This is a three-arm multi-centre head-to-head randomised trial comparing two treatments against a low dose oral immunotherapy approach for peanut allergy
One hundred and thirty children aged 1 year to 10 years with current peanut allergy confirmed by failed double-blind placebo-controlled food challenge DBPCFC at study screening will be recruited for this study Participants will be recruited from The Royal Childrens Hospital Melbourne Womens and Childrens Hospital Adelaide and from the general community
Participants will be randomized to
1 High-dose rapid escalation peanut OIT combined with probiotic HD PPOIT
2 High-dose rapid escalation peanut OIT combined with probiotic placebo HD OIT
3 Low-dose slow escalation peanut OIT combined with probiotic placebo LD OIT
The length of the treatment period for each participant is 18 months and the post-treatment follow up period is 12 months
One hundred and thirty children aged 1 year to 10 years with current peanut allergy confirmed by failed double-blind placebo-controlled food challenge DBPCFC at study screening will be recruited for this study Participants will be recruited from The Royal Childrens Hospital Melbourne Womens and Childrens Hospital Adelaide and from the general community
Participants will be randomized to
1 High-dose rapid escalation peanut OIT combined with probiotic HD PPOIT
2 High-dose rapid escalation peanut OIT combined with probiotic placebo HD OIT
3 Low-dose slow escalation peanut OIT combined with probiotic placebo LD OIT
The length of the treatment period for each participant is 18 months and the post-treatment follow up period is 12 months
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
True
Is an FDA AA801 Violation?:
None