Status:
COMPLETED
AN-PEP on Gluten Exposure in Celiacs
Lead Sponsor:
Dr. C. Bonorino Udaondo Gastroenterology Hospital
Conditions:
Celiac Disease
Eligibility:
All Genders
17-75 years
Phase:
PHASE4
Brief 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 g...
Detailed Description
Background: The strict gluten-free diet (GFD) is the only accepted treatment for celiac disease (CeD). However, performing a strict diet is still a non solved problem affecting the future of patients....
Eligibility Criteria
Inclusion
- 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
- 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,).
Key Trial Info
Start Date :
March 17 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 31 2022
Estimated Enrollment :
40 Patients enrolled
Trial Details
Trial ID
NCT04788797
Start Date
March 17 2021
End Date
July 31 2022
Last Update
February 24 2023
Active Locations (1)
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1
Dr. C. Bonorino Udaondo Gastroenterology Hospital
Ciudad Autonoma de Buenos Aires, Buenos Aires, Argentina, 1602