Study On The Effectiveness Of Oral Administration Of Prolyl Endoprotease For Gluten Detoxification As A Means To Treat Coeliac Disease

Completed

• Conditions: Coeliac disease; 10017947; 10003816

• Registration Number: NL-OMON31647
• Lead Sponsor: DSM Food Specialties

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Last Update Posted: 13 May 2024

Recruitment & Eligibility

• Status: Completed
• Sex: Not specified
• Target Recruitment: 14

Inclusion Criteria

* Confirmed diagnosis of coeliac disease (Marsh III B/C)
* Detectable coeliac disease specific antibodies (EMA, tTGA) at time of diagnosis.
* A strict gluten free diet for at least 1 year and normalised villous architecture (Marsh 0/I);
* Male and female, 18-70 years old;
* No detectable anti-endomysium and low anti-tissue transglutaminase (< 4 U/ml) prior to the start of the study;
* Patient is willing to undergo all protocol related assessments and visits (including up to 3 separate oesophago-gastro-duodenoscopies with multiple biopsies taken each time) from the duodenum descendents;
* Patient has read the information provided on the study and given written consent;
* Female participants at fertile age must use adequate contraception.

Exclusion Criteria

* Use of any immunoregulatory drug within the last 6 months;
* Use of any anticoagulant drug;
* Clinically suspected bleeding tendency;
* Pregnancy or breast feeding;
* Presence of any concurrent active infection;
* IgA deficiency.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>To investigate in vivo AN-PEP activity, small intestinal biopsy material will<br /><br>be analysed for the following:<br /><br>* Histopathological changes according to the Modified Marsh criteria.<br /><br>* The presence and activity of gluten reactive T cells isolated from biopsies.<br /><br>* The immunophenotype of lymphocytes (IEL and LPL) isolated from biopsies.<br /><br><br /><br>To investigate in vivo AN-PEP activity, peripheral blood samples will be<br /><br>analysed for the following:<br /><br>* The presence and activity of gluten reactive T cells.<br /><br>* The presence of coeliac disease specific antibodies (EMA, tTGA).</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>Not applicable</p><br>