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AN-PEP on Gluten Exposure in Celiacs

NCT04788797 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 40

Last updated 2023-02-24

No results posted yet for this study

Summary

The AN-PEP, an Aspergillus niger derived endopeptidase, has been developed aiming to produce a complete luminal detoxification of gluten. If AN-PEP is able to produce a complete luminal digestion of gluten in the context of the real life of celiac disease (CeD) patients is unknown. Hypothetically, AN-PEP effect could be detected by the reduction in the excretion of GIP in stool and urine.

The objective of this study is to establish the effect of the daily administration of AN-PEP compared to placebo on GIP excretion in an interventional, prospective, randomized, comparative, double-blind study in conditions mimicking the real-life of CeD treated patients. The study consists in a four-week GFD stabilization period followed by a four-week study period with patients randomized to receive active AN-PEP or placebo in a blindly manner.

Conditions

Interventions

DRUG

Prolyl Endopeptidase

Two capsules three times a day.

OTHER

Placebo

Two capsules three times a day

Sponsors & Collaborators

  • Dr. C. Bonorino Udaondo Gastroenterology Hospital

    lead OTHER_GOV

Principal Investigators

  • Edgardo G Smecuol · Dr. C. Bonorino Udaondo Gastroenterology Hospital

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
17 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-03-17
Primary Completion
2022-07-30
Completion
2022-07-31
FDA Drug
Yes

Countries

  • Argentina

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04788797 on ClinicalTrials.gov