Novogluten Clinical Gluten

Consistency in clinical gluten for calibrated food challenges 

Novogluten is a standardized gluten powder for gluten challenges that provides greater confidence to patients, clinicians and researchers that the effects they observe following gluten food challenge in patients with celiac disease are due to a calibrated activation of gluten-specific immunity.

Consistent, credible and convenient gluten challenges throughout your program

Novogluten has undergone extensive characterization beyond standard protein, water, R5-ELISA, and microbiology assessments to provide a resource that is essential for high-fidelity gluten challenge. It is also assessed in ongoing stability studies in various storage conditions and packaging.

Gluten challenges are simplified for patients and clinicians with customizable single-serve, pre-packaged servings that are mixed with liquid in a NovoGluten shaker.

Same batch for your entire program, from concept to approval

75-80% pure gluten protein, low FODMAPs and pathogen free

Customize for SIDE, single-bolus or extended challenges

Combining expertise in gluten immunogenicity and food chemistry to support your program

Gluten food challenges must be tolerable and potent to inform clinical care and facilitate study endpoints. Selecting material for gluten challenges to achieve these outcomes requires recognition of gluten immunogenicity and food chemistry. as well as basic food safety assessments. Our specialists at Novoviah have over 25-years experience in designing, managing and interpreting gluten food challenges in clinical care, immunology research and in pharmaceutical development.

Novoviah works with clients to:

• support and advise on gluten food challenge design, protocols and readouts
• advise how immune and symptom readouts (serum cytokines or Novoleukin-C whole blood cytokine release tests) can be incorporated
• ensure suitable labelling and documentation to comply with IRB/HREC approvals, and food standards
• assembling a Novogluten gluten challenge database with details of readouts to inform study design, statistical powering and analysis.