NovoGluten Clinical Gluten

for Calibrated Gluten Food Challenges 

Gluten food challenges must be tolerable and potent to inform clinical care and facilitate study endpoints. To achieve these outcomes selecting material for gluten challenges requires some prior knowledge 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.


Convenient, consistent and credible in gluten challenges throughout your program.

  • Standardized gluten powder for gluten challenges.


  • Extensive charcterization.


  • Same batch for your entire program from concept to approval.


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


  • Prepackaged servings to be mixed with liquid in a NovoGluten shaker.


  • Building and understanding of dose response.


Novoviah is launching NovoGluten to simplify gluten food challenges.

Our aim is to provide greater confidence to patients, clinicians and researchers that the effects they observe following gluten food challenge in patients with celiac disease or other gluten-mediated disease are due to a calibrated reactivation of gluten-specific immunity rather than irritable bowel syndrome or other non-immune effects.

Symptoms, immune and intestinal effects of gluten in celiac disease may be confounded by quantitative and qualitative aspects of the gluten food challenge.

Large, well characterised single-source stocks of Vital Wheat Gluten provide a resource that is essential for high-fidelity gluten challenge. NovoGlutenTM is extensively tested well beyond standard protein, water, R5-ELISA, and microbiology assessments. The NovoGlutenTM stock is also assessed in ongoing stability studies in various storage conditions and packaging.

Novoviah works with clients to:

  1. Customize single-serve packaging to ensure appropriate dosing for single-bolus or extended challenges.
  2. Support and advise on gluten food challenge design, protocols and readouts.
  3. Advise how immune and symptom readouts such as serum cytokines or whole blood cytokine release tests such as the Novoleukin-C system can be incorporated
  4. Work with CRO’s to ensure suitable labelling and documentation to comply with IRB/HREC approvals, and import/export documentation


To support users, Novoviah is assembling a NovoGlutenTM - gluten challenge database with details of readouts to inform study design, statistical powering and analysis.

Order Enquiry

For further information on NovoGluten and incorporating gluten challenge in your clinical care or study please complete an order enquiry.

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