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Allergenicity Assessment of Green Marine Macroalga Ulva sp.

NCT06452381 · Status: ACTIVE_NOT_RECRUITING · Type: OBSERVATIONAL · Enrollment: 120

Last updated 2024-06-11

No results posted yet for this study

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

Sponsors & Collaborators

  • Tel Aviv University

    collaborator OTHER

  • Meir Medical Center

    lead OTHER

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2022-05-18
Primary Completion
2025-03-09
Completion
2025-03-09

Countries

  • Israel

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06452381 on ClinicalTrials.gov