Ignite Creation Date:
2025-12-17 @ 10:10 PM
Ignite Modification Date:
2025-12-18 @ 3:02 AM
Study NCT ID:
NCT00736281
Status:
None
Last Update Posted:
2016-06-17 00:00:00
First Post:
2008-08-14 00:00:00
Is Possible Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Sublingual Immunotherapy for Food Allergy
Sponsor:
None
Organization:
Study Overview
Official Title:
Sublingual Immunotherapy for Food Allergy
Status:
None
Status Verified Date:
2016-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Due to recently published research, this is no longer a novel study.
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Design:
Randomized-controlled blinded trial to evaluate the safety and efficacy of sublingual immunotherapy for food allergy sufferers. The study will report any adverse events caused by the administration of food allergy drops. Food allergy can manifest itself in many forms including general fatigue, abdominal pain, GERD, nausea, and other symptoms.
End Points:
Comparison between groups 1 and 2 about patient-reported adverse, as well as beneficial, events while on food allergy immunotherapy at 3, 6, 9, 12 months after maintenance dose is achieved (SLIT questionnaire). These comparisons relate to both safety and efficacy issues.
Methodology:
Trial subjects will be identified by their presenting complaints due to ingestion of certain symptomatic foods. Clinical assessment of potential food allergy participants for SLIT will occur according to usual testing standards. All participants will have diagnostic tests (usually RAST analysis and or food challenge techniques) to confirm specific food allergies. Subjects who meet the inclusion criteria will be asked to participate in the study through informed consent. Once consent has been obtained, the subject will be randomly assigned to either the control or the intervention group.
Group 1 (control group) will receive sublingual immunotherapy (escalation followed by maintenance) with vials containing glycerin.
Group 2 (intervention group) will receive sublingual immunotherapy (escalation followed by maintenance) with vials containing glycerin and the previously diagnosed food allergens.
After the offending foods are diagnosed, the subject will be instructed to avoid these foods until they have been on the 9-week escalation doses and the maintenance immunotherapy dose for six months. After this eight-month combined period of escalation and maintenance, the participants will be allowed to reintroduce the known offending foods. In addition, participants will be asked to respond to questionnaires at pre-defined intervals in regards to any adverse symptoms they may have experienced while on maintenance SLIT. These questionnaires will allow us to determine if food drops contribute to adverse events, as well as how effective the drops are at suppressing immune response to previously allergic foods.
Procedures:
At the initial clinic visit, potential subjects will be asked to elaborate on specific food allergy symptoms in order to obtain a better understanding of the food allergies involved. Also, diagnostic tests will be performed based on signs and symptoms and these can include:
1. Clinical History
2. Radioallergosorbent Test (RAST)
3. Oral Food Challenge Participants in the intervention group will receive SLIT with glycerin and individualized food allergens. Subjects in the control group will receive SLIT with glycerin only.
The expected length for an individual's participation is sixteen to eighteen months. This period includes the time between the initial clinic visit and diagnostic work-up, the achievement of SLIT maintenance dose, and the 3,6,9,12 month post-maintenance dose safety questionnaires.
Stopping rules apply to the intervention and placebo groups in the case of an adverse event.
Randomized-controlled blinded trial to evaluate the safety and efficacy of sublingual immunotherapy for food allergy sufferers. The study will report any adverse events caused by the administration of food allergy drops. Food allergy can manifest itself in many forms including general fatigue, abdominal pain, GERD, nausea, and other symptoms.
End Points:
Comparison between groups 1 and 2 about patient-reported adverse, as well as beneficial, events while on food allergy immunotherapy at 3, 6, 9, 12 months after maintenance dose is achieved (SLIT questionnaire). These comparisons relate to both safety and efficacy issues.
Methodology:
Trial subjects will be identified by their presenting complaints due to ingestion of certain symptomatic foods. Clinical assessment of potential food allergy participants for SLIT will occur according to usual testing standards. All participants will have diagnostic tests (usually RAST analysis and or food challenge techniques) to confirm specific food allergies. Subjects who meet the inclusion criteria will be asked to participate in the study through informed consent. Once consent has been obtained, the subject will be randomly assigned to either the control or the intervention group.
Group 1 (control group) will receive sublingual immunotherapy (escalation followed by maintenance) with vials containing glycerin.
Group 2 (intervention group) will receive sublingual immunotherapy (escalation followed by maintenance) with vials containing glycerin and the previously diagnosed food allergens.
After the offending foods are diagnosed, the subject will be instructed to avoid these foods until they have been on the 9-week escalation doses and the maintenance immunotherapy dose for six months. After this eight-month combined period of escalation and maintenance, the participants will be allowed to reintroduce the known offending foods. In addition, participants will be asked to respond to questionnaires at pre-defined intervals in regards to any adverse symptoms they may have experienced while on maintenance SLIT. These questionnaires will allow us to determine if food drops contribute to adverse events, as well as how effective the drops are at suppressing immune response to previously allergic foods.
Procedures:
At the initial clinic visit, potential subjects will be asked to elaborate on specific food allergy symptoms in order to obtain a better understanding of the food allergies involved. Also, diagnostic tests will be performed based on signs and symptoms and these can include:
1. Clinical History
2. Radioallergosorbent Test (RAST)
3. Oral Food Challenge Participants in the intervention group will receive SLIT with glycerin and individualized food allergens. Subjects in the control group will receive SLIT with glycerin only.
The expected length for an individual's participation is sixteen to eighteen months. This period includes the time between the initial clinic visit and diagnostic work-up, the achievement of SLIT maintenance dose, and the 3,6,9,12 month post-maintenance dose safety questionnaires.
Stopping rules apply to the intervention and placebo groups in the case of an adverse event.
Detailed Description:
None
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?: