Allergenicity Assessment of Green Marine Macroalga Ulva sp.

NCT06452381 | Active Not Recruiting DMC

• 2 other identifiers: MMC-0207-213-16052
• Study Type: observational
• Target: 120
• Locations: 1 country
• Sites: 1

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 (\>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.

Conditions

Food Allergy

Outcome Measures

Primary Outcomes (1)

• An allergic reaction to the food challenge

  After 6 weeks of repeated eating 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 or its absence is the primary outcome.

  10 weeks

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Healthy adults

You may qualify if:

• Adults (\>18)
• Males and females (10 males and 10 females) with no history of food allergy or atopy

You may not qualify if:

• 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).

Sponsors & Collaborators

• Meir Medical Center: lead
• Tel Aviv University: collaborator

Study Sites (1)

Meir Medical Center

Kfar Saba, 428164, Israel

Location

Related Publications (1)

• Kedar O, Golberg A, Obolski U, Steinbruch E, Chemodanov A, Israel A, Livney YD, Lachover-Roth I, Rosman Y, Confino-Cohen R. Initial allergenicity assessment of Ulva sp. seaweed flour. NPJ Sci Food. 2025 Dec 3;10(1):1. doi: 10.1038/s41538-025-00638-x.

  PMID: 41339625 DERIVED

Biospecimen

Retention: SAMPLES WITHOUT DNA

Serum

MeSH Terms

Conditions

Food Hypersensitivity

Condition Hierarchy (Ancestors)

Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Target Duration: 100 Months
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Prof

Study Record Dates

• First Submitted: June 5, 2024
• First Posted: June 11, 2024
• Study Start: May 18, 2022
• Primary Completion: March 9, 2025
• Study Completion: March 9, 2025
• Last Updated: June 11, 2024

Record last verified: 2024-06

Locations

IL (1)