AN-PEP on Gluten Exposure in Celiacs

• Status: Recruiting
• Trial end date: 2022-12-31
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Dr. C. Bonorino Udaondo Gastroenterology Hospital

Criteria

Inclusion Criteria:

• Over 18 years

• Diagnosis of celiac disease

• Completion of Gluten-free Diet for at least two years without evidence of voluntary violations.

• Patients who do not report symptoms of constipation or illnesses or medications (cathartics, antidiarrheals, etc.) that alter the bowel movement rhythm (accepted rhythm: between 2 times / day to 1 every other day) and diuresis (diuretics). Proton-pump inhibitor.

• Signature of the informed consent

Exclusion Criteria:

• Patients not interested or unable to collaborate with the questionnaires and collection of fecal matter.

• Place of residence of the participant more than 4 hours from the hospital, which interferes with the viability of the sample.

• Complicated CD (refractory CD type II, ulcerative jejunoileitis, lymphoma).

• Concomitant pathologies that are decompensated or untreated at study entry (type I or II diabetes mellitus; hyperthyroidism; hypothyroidism; kidney failure,).