Ignite Creation Date:
2024-06-16 @ 11:52 AM
Last Modification Date:
2024-10-26 @ 3:31 PM
Study NCT ID:
NCT06452381
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2024-06-11
First Post:
2024-06-05
Brief Title:
Allergenicity Assessment of Green Marine Macroalga Ulva sp
Sponsor:
Meir Medical Center
Organization:
Meir Medical Center
Study Overview
Official Title:
Towards Sustainable Food Systems Allergenicity Assessment of Green Marine Macroalga Ulva sp
Status:
ACTIVE_NOT_RECRUITING
Status Verified Date:
2024-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
To determine the allergenic potential in humans we will conduct a three-stage clinical trial
In the first group 20 healthy volunteers will be involved All volunteers will be examined by an allergy specialist before enrolment to the study After receiving informed consent all volunteers will undergo an allergy skin test to the study seaweed proteins as well as to common allergens Participants with a skin test showing sensitization will be excluded Volunteers will be fed by 5 gram of the study seaweed 2 times a week under supervision for 6 weeks After 6 weeks of feeding skin tests will be repeated All participants will undergo an open oral food challenge after one month of avoidance of the study seaweed protein Uneventful food challenge will rule out food allergy in a specific volunteer
Second the extension clinical phase will be conducted with 100 healthy volunteers The inclusion exclusion and study design will be similar to the pilot study
The third phase will be conducted in a group of high-risk patients aimed to find the frequency of allergy to the study seaweed in high risk patients Study population 20 volunteers with high risk to seaweed food allergy Inclusion criteria Adults gt18 years old males and females with at least one of the following Active atopic dermatitis or fish or sea food allergy Study design will be similar to the pilot study
In the first group 20 healthy volunteers will be involved All volunteers will be examined by an allergy specialist before enrolment to the study After receiving informed consent all volunteers will undergo an allergy skin test to the study seaweed proteins as well as to common allergens Participants with a skin test showing sensitization will be excluded Volunteers will be fed by 5 gram of the study seaweed 2 times a week under supervision for 6 weeks After 6 weeks of feeding skin tests will be repeated All participants will undergo an open oral food challenge after one month of avoidance of the study seaweed protein Uneventful food challenge will rule out food allergy in a specific volunteer
Second the extension clinical phase will be conducted with 100 healthy volunteers The inclusion exclusion and study design will be similar to the pilot study
The third phase will be conducted in a group of high-risk patients aimed to find the frequency of allergy to the study seaweed in high risk patients Study population 20 volunteers with high risk to seaweed food allergy Inclusion criteria Adults gt18 years old males and females with at least one of the following Active atopic dermatitis or fish or sea food allergy Study design will be similar to the pilot study
Detailed Description:
To determine the allergenic potential in humans we will conduct a three-stage clinical trial The length of each phase will be 3 months Serum will be sampled from all the participants before and at the end of each phase
In the first group 20 volunteers will be involved Inclusion criteria Adults gt18 Males and females 10 males and 10 females with no history of food allergy or atopy Exclusion criteria any history of food allergy women pregnant or lactating any history of atopy moderatesevere atopic dermatitis allergic rhinitis asthma any chronic diseases any chronic medication use except CP
Study design All volunteers will be examined by an allergy specialist before enrolment to the study to rule out any of the exclusion criteria Volunteers with any of the exclusion criteria will be excluded from participation in this part of the study After receiving informed consent all volunteers will undergo an allergy skin test to the study seaweed proteins as well as to fish sea foods peanut sesame milk soy house dust mite and common Israeli pollens Participants with a skin test showing sensitization by skin tests will be excluded from this part of the study All volunteers passing the above stages will be enrolled Volunteers will be fed by 5 gram of the study seaweed 2 times a week under supervision for 6 weeks After 6 weeks of feeding skin tests will be repeated All participants disregarding the results of the skin test will undergo an open oral food challenge after one month of avoidance of the study seaweed protein The open oral food challenge will include ingestion of 5 gram of the study seaweed protein and 2 hours of observation An allergic reaction to the food challenge will be determined by the allergy specialist conducting the food challenge by predefined clinical signs and symptoms If needed first aid treatment will be provided by the allergy specialist Uneventful food challenge will rule out food allergy in a specific volunteer Expected results we assume that the study seaweed is not more allergenic than other common foods Thus we expect that no more than one volunteer will have a reaction to the food challenge
Second the extension clinical phase will be conducted with 100 healthy volunteers The sample size was based on the prevalence of IgE mediated food allergy of all kinds in the general population and engineering constraints for extraction process scale up Finding at least one person with the allergy should be around 63 confidence under the prevalence of 1 and 95 confidence under a prevalence of 3 and a sample size of 100 The inclusion exclusion and study design will be similar to the pilot study Blood test will be drawn from patients that will be found to be allergic to the seaweed in order to try to define specific allergenic epitopes of the seaweed Expected outcomes allergy to the study seaweed will be found in less than 5 of healthy volunteers
The third phase will be conducted in a group of high-risk patients aimed to find the frequency of allergy to the study seaweed in high risk patients Study population 20 volunteers with high risk to seaweed food allergy Inclusion criteria Adults gt18 years old males and females with at least one of the following Active atopic dermatitis or fish or sea food allergy Study design will be similar to the pilot study Blood tests will be drawn from patients that will be found to be allergic to the seaweed in order to try and define specific allergenic epitopes of the seaweed We expect that allergy to the study seaweed protein will be found in less than 10 of high-risk volunteers
In the first group 20 volunteers will be involved Inclusion criteria Adults gt18 Males and females 10 males and 10 females with no history of food allergy or atopy Exclusion criteria any history of food allergy women pregnant or lactating any history of atopy moderatesevere atopic dermatitis allergic rhinitis asthma any chronic diseases any chronic medication use except CP
Study design All volunteers will be examined by an allergy specialist before enrolment to the study to rule out any of the exclusion criteria Volunteers with any of the exclusion criteria will be excluded from participation in this part of the study After receiving informed consent all volunteers will undergo an allergy skin test to the study seaweed proteins as well as to fish sea foods peanut sesame milk soy house dust mite and common Israeli pollens Participants with a skin test showing sensitization by skin tests will be excluded from this part of the study All volunteers passing the above stages will be enrolled Volunteers will be fed by 5 gram of the study seaweed 2 times a week under supervision for 6 weeks After 6 weeks of feeding skin tests will be repeated All participants disregarding the results of the skin test will undergo an open oral food challenge after one month of avoidance of the study seaweed protein The open oral food challenge will include ingestion of 5 gram of the study seaweed protein and 2 hours of observation An allergic reaction to the food challenge will be determined by the allergy specialist conducting the food challenge by predefined clinical signs and symptoms If needed first aid treatment will be provided by the allergy specialist Uneventful food challenge will rule out food allergy in a specific volunteer Expected results we assume that the study seaweed is not more allergenic than other common foods Thus we expect that no more than one volunteer will have a reaction to the food challenge
Second the extension clinical phase will be conducted with 100 healthy volunteers The sample size was based on the prevalence of IgE mediated food allergy of all kinds in the general population and engineering constraints for extraction process scale up Finding at least one person with the allergy should be around 63 confidence under the prevalence of 1 and 95 confidence under a prevalence of 3 and a sample size of 100 The inclusion exclusion and study design will be similar to the pilot study Blood test will be drawn from patients that will be found to be allergic to the seaweed in order to try to define specific allergenic epitopes of the seaweed Expected outcomes allergy to the study seaweed will be found in less than 5 of healthy volunteers
The third phase will be conducted in a group of high-risk patients aimed to find the frequency of allergy to the study seaweed in high risk patients Study population 20 volunteers with high risk to seaweed food allergy Inclusion criteria Adults gt18 years old males and females with at least one of the following Active atopic dermatitis or fish or sea food allergy Study design will be similar to the pilot study Blood tests will be drawn from patients that will be found to be allergic to the seaweed in order to try and define specific allergenic epitopes of the seaweed We expect that allergy to the study seaweed protein will be found in less than 10 of high-risk volunteers
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?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 3-16052 | OTHER_GRANT | The Chief Scientist Fund Ministry of Health | None |