Ignite Creation Date:
2024-10-26 @ 3:38 PM
Last Modification Date:
2024-10-26 @ 3:38 PM
Study NCT ID:
NCT06558526
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2024-08-14
Brief Title:
Pectin Intervention Study and Long-term Follow-up in Lipid Transfer Proteins Allergic Patients
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Analysis of the Clinical Efficacy and Immunomodulatory Effect of Pectin in LTP Allergic Patients Through a Placebo-controlled Intervention Study and Long-term Follow-up
Status:
NOT_YET_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:
PI2300820
Brief Summary:
Pectins are dietary fibers that have shown a health effect on patients with food allergy as they are capable of modifying the composition of gastrointestinal microbiota and producing an immunomodulatory effect Preliminary results by the investigators show that the intervention for 2 months with pectins produces an increase in tolerance to peach and changes in the microbiota compared to the group of patients treated with placebo In this project the investigators aim to study these clinical effects and the involved mechanisms Moreover the long-term effect clinical reactivity to nsLTP and immunomodulatory effect of the dietary intervention will be prospectively evaluated 6 months after the intervention
Detailed Description:
Patients of 3 different Allergy Units with clinical history of allergic reactions with peach and withwithout reactions with peanut due to sensitization to nsLTP will be informed about the intervention study and potential risks After obtention of written informed consent screening phase evaluation will be performed skin prick tests SPT obtention of blood and feces samples and double-blind placebo-controlled food challenges DBPCFC with peach and peanut Participants who meet the eligibility requirements will be randomized in a ratio 11 to pectin apple pectin 10 mg maltodextrin 5 mg once daily or placebo maltodextrin 5 mg once daily The dietary intervention will last 6 months and a follow-up visit in month 3 will be performed After completing the dietary intervention all participants will be clinically assessed SPT and DBPCFC and new blood and feces samples will be collected Finally patients who receive the active will be clinically evaluated with DBPCFC to peach and peanut after 6 months of completing the dietary intervention Also new blood and feces samples will be obtained
The main objective is to analyze the clinical efficacy of a pectin dietary supplement administered once a day for 6 months as a treatment for nsLTP allergy in a randomized double-blind placebo-controlled multicenter intervention study In addition the investigators will study changes in clinical reactivity to nsLTP and the immunomodulatory effect immunological humoral and cellular metabolomics and microbiota profiles Furthermore long-term effects of the dietary intervention will be analyzed in participants from the active group pectin 6 months after completing the intervention
The main objective is to analyze the clinical efficacy of a pectin dietary supplement administered once a day for 6 months as a treatment for nsLTP allergy in a randomized double-blind placebo-controlled multicenter intervention study In addition the investigators will study changes in clinical reactivity to nsLTP and the immunomodulatory effect immunological humoral and cellular metabolomics and microbiota profiles Furthermore long-term effects of the dietary intervention will be analyzed in participants from the active group pectin 6 months after completing the intervention
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