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

Study On The Effectiveness Of Oral Administration Of Prolyl Endoprotease For Gluten Detoxification As A Means To Treat Coeliac Disease - AN-PEP supportive treatment in coeliac disease

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

NL-OMON

Registry ID

NL-OMON31647

Enrollment

Registered

2008-03-26

Start date

2008-05-05

Completion date

Unknown

Last updated

2024-05-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Coeliac disease

Interventions

None listed

Eligibility

Age

18 Years to 99 Years

Inclusion criteria

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 (

Exclusion criteria

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.

Design outcomes

Primary

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

Measure

Time frame

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

—

Countries

Netherlands

Outcome results