Enabling Study to assess Gluten Sensitivity in Coeliac Disease

• Research type

  Research Study

• Full title

  A two-part study to evaluate the relationship between gluten dose and immunological response in patients with Coeliac Disease undergoing gluten challenge and the influence of prior exposure to gluten on subsequent responses to a second challenge using both a double-blind 3-day gluten challenge and a novel open-label intra-patient fixed ascending gluten dose approach.

• IRAS ID

  292464

• Contact name

  Edward Banham-Hall

• Contact email

  edward.j.banham-hall@gsk.com

• Sponsor organisation

  GlaxoSmithKline (GSK)

• Duration of Study in the UK

  1 years, 4 months, 12 days

• Research summary

  Summary of Research
  Coeliac Disease (CeD) is a common disorder driven by an immune response to dietary gluten. The standard treatment for CeD is maintaining a gluten free diet (GFD), however most patients are still exposed to a small amount of gluten in their diet which has been found to initiate an immune response that can result in CeD symptoms.
  The main objective of this study is to understand the relationship between different gluten doses and the immune response in CeD patients through the analysis of various immune markers following a gluten challenge; including whether the immune system will respond in a similar manner to the same gluten dose sometime later in the same patient. As well as assessing immune markers the study will also assess patient symptoms at different doses of gluten.
  The study will include 40 Coeliac Disease patients, including both males and females.
  The study will consist of 2 parts, Part 1(a/b) and Part 2(a/b).
  Both parts will include:
  • A screening period of up to 28 days
  • The first gluten challenge period- (subpart a)
  • A break of up to 2 months
  • A repeat gluten challenge period- (subpart b)
  • A follow-up visit after the last dose of each challenge period.

  Part 1 (Randomised, double blind):
  20 participants
  Each participant will be randomised to receive one of three doses of the gluten challenge daily for a period of three days.
  • Part 2 (Open Label):

  20 participants
  Each participant will receive five fixed increasing doses of the gluten challenge.
  This study will have no direct medical benefit to the participants. It is a GSK-sponsored study and will be conducted in an (MHRA)-accredited clinical research unit in the United Kingdom, with appropriate safety and compliance facilities.

  Summary of Results
  The study is Tier-2 so is out of scope for development and disclosure of a lay summary.
  The results summary is available on the GSK study register

• REC name

  West Midlands - Black Country Research Ethics Committee

• REC reference

  21/WM/0027

• Date of REC Opinion

  3 Mar 2021

• REC opinion

  Further Information Favourable Opinion