Clinical Study for Coeliac Patients

We are looking for coeliac patients for a clinical study.

We are looking for coeliac patients, who still have symptoms despite following a gluten-free diet, for a phase IIb clinical study. The double-blind, randomised, multicentre, placebo-controlled, comparative phase IIb study investigates the effect and tolerability of ZED1227, a tissue transglutaminase (TG2) inhibitor in the form of a hard capsule for oral administration, in the treatment of coeliac disease.

Main Inclusion criteria

  1. The patient is between 18 and 80 years of age
  2. Biopsy-proven diagnosis of coeliac disease at least 12 months prior
  3. Adherence to a gluten-free diet (GFD) for at least 12 months
  4. Human leukocyte antigen DQ (HLA-DO) typing compatible with coeliac disease (if known)
  5. Symptoms (diarrhoea and/or abdominal pain and/or bloating and/ or nausea) despite GD
  6. Negative diagnosis of Helicobacter pylori infection and no eradication within the last two months (if known)
  7. BMI between 17.0 and 35, inclusively
  8. Willing to maintain current FD throughout participation in the trial

Should you be interested in referring potential candidates to us, have questions or need more information, please contact:

Dr Hans Seltenreich

Coastal Digestive Health

503/5 Emporio Place, Maroochydore

07 5408 0900

admin@coastaldigestivehealth.com.au

503/5 Emporio Place, Maroochydore
07 5408 0900

E: admin@coastaldigestivehealth.com.au

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