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Study to Evaluate the Potential of Air Structuring Protein to Elicit Allergic Reactions in Mold Sensitized People

The recruitment status of this study is unknown because the information has not been verified recently.
Verified December 2011 by Unilever SEAC.
Recruitment status was  Recruiting
Sponsor:
Information provided by (Responsible Party):
Unilever SEAC
ClinicalTrials.gov Identifier:
NCT01494194
First received: December 12, 2011
Last updated: December 14, 2011
Last verified: December 2011
  Purpose

Air Structuring Protein (ASP) is a small protein derived from a fungus which is already widely used to produce enzymes that are added to foods. ASP has the possibility of stabilising the air phase of ice-cream and therefore there is interest in ASP as a potential ice-cream ingredient.

Toxicological tests have also been carried out to further confirm the safety of the material and no evidence of genotoxicity or acute toxicity has been observed in any of the tests.

As part of the safety evaluation of a new protein for use in foods, the potential allergenicity is also investigated and Unilever is sponsoring a study to evaluate this aspect of ASP. This study will investigate:

  • Whether ASP has the potential to elicit a positive skin prick test (SPT) in a population of participants with proven sensitivity to mould.
  • Whether ASP is responsible for any positive SPT reactions, should they occur.
  • And if any positive SPT reactions to ASP occur, whether such reactions are clinically relevant with respect to food allergy.

The study is divided in three stages. In Stage 1 and Stage 2, the SPT is "open label," which means that both the participant and the study doctor will know which materials are being tested.

In Stage 3, the food challenge has a "crossover" design, meaning that participants will take one of the products (ASP or placebo [food containing no ASP]) during the first half of the study and the other treatment during the second half. The order of ASP and placebo will be decided randomly, like tossing a coin. To make the comparison between ASP and placebo as fair as possible, the food challenge is "double blinded." This means that neither the participant nor the study doctor will know which kind of products (ASP or placebo) the participant is taking.

This is a multi centre study which is taking place in the UK.


Condition Intervention
Allergy to Mold
Other: Air Structuring Protein
Other: Placebo sorbet

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Open Label
Official Title: Evaluation of the Potential of Air Structuring Protein, a Novel Protein Preparation Derived From Trichoderma Reesei, to Elicit Allergic Reactions in Mold Sensitized People

Resource links provided by NLM:


Further study details as provided by Unilever SEAC:

Primary Outcome Measures:
  • Positive skin prick test response to test material [ Time Frame: 15 minutes after application ] [ Designated as safety issue: No ]
    The number and size of positive SPTs will be recorded together with data of concomitant allergies and the minimum eliciting concentration (SPT-min) in the skin.


Secondary Outcome Measures:
  • The number of positive Double Blind Placebo Controlled Food Challenge reactions in those with positive skin prick test result [ Time Frame: 2 hours after administration ] [ Designated as safety issue: No ]
    The number of positive DBPCFC reactions will be recorded together with pre and post challenge blood pressure, pulse rate, peak expiratory flow (PEF) and forced expiratory volume (FEV1), data of concomitant allergies, any symptoms elicited including any late onset reactions, timing of symptoms and the minimum eliciting dose of ASP.


Estimated Enrollment: 250
Study Start Date: December 2011
Estimated Primary Completion Date: June 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Placebo Comparator: placebo for food challenge Other: Placebo sorbet
Placebo sorbet for double blind placebo controlled food challenge
Experimental: ASP Skin prick solution Other: Air Structuring Protein
A novel food protein preparation
Experimental: ASP sorbet Other: Air Structuring Protein
A novel food protein preparation

  Eligibility

Ages Eligible for Study:   18 Years to 60 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Males and females aged 18-60 years.
  • Mould sensitised subjects diagnosed according to the EAACI/Ga2len guidelines.
  • Written informed consent from the subject.
  • Normally active and otherwise judged to be in good health on the basis of medical history and screening assessment.
  • No allergic symptoms on the day of investigation.

Exclusion Criteria:

  • Pregnancy or lactation.
  • Failure to comply with the protocol.
  • Medication that may interfere with wheal formation in the skin or response to DBPCFC
  • Participation in another clinical study involving a SPT within 30 days prior to Visit 1 or DBPCFC within 30 days prior to DBPCFC.
  • Current skin disease of any type (eczema, acne, dermatitis, etc.) on the test site(s).
  • Subjects with a condition the Investigator believes would interfere with the evaluation of the subject, including proceeding to DBPCFC, or may put the subject at undue risk, e.g., a history of anaphylactic reactions and history of reactions to any component of the DBPCFC matrix other than ASP.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01494194

Contacts
Contact: Naomi Glaser +44 (0)2083981698 Naomi.Glaser@parexel.com

Locations
United Kingdom
National Heart and Lung Institute, MRC & Asthma UK Centre in Allergic Mechanisms of Asthma, Centre for Respiratory Infection, Imperial College London Recruiting
London, United Kingdom, W2 1PG
Principal Investigator: Sebastien Johnson, MD         
Sponsors and Collaborators
Unilever SEAC
  More Information

No publications provided

Responsible Party: Unilever SEAC
ClinicalTrials.gov Identifier: NCT01494194     History of Changes
Other Study ID Numbers: KQC100140
Study First Received: December 12, 2011
Last Updated: December 14, 2011
Health Authority: United Kingdom: National Health Service

Keywords provided by Unilever SEAC:
Mold sensitized

Additional relevant MeSH terms:
Hypersensitivity
Immune System Diseases

ClinicalTrials.gov processed this record on November 25, 2014