Clinical Trial Details
— Status: Active, not recruiting
Administrative data
| NCT number |
NCT06452381 |
| Other study ID # |
MMC-0207-21 |
| Secondary ID |
3-16052 |
| Status |
Active, not recruiting |
| Phase |
|
| First received |
|
| Last updated |
|
| Start date |
May 18, 2022 |
| Est. completion date |
March 9, 2025 |
Study information
| Verified date |
June 2024 |
| Source |
Meir Medical Center |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Observational [Patient Registry]
|
Clinical Trial 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 (>18 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.
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 (>18);
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 (moderate/severe 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 (>18 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.
