Ignite Creation Date:
2024-05-06 @ 3:52 PM
Last Modification Date:
2024-10-26 @ 1:59 PM
Study NCT ID:
NCT04788797
Status:
COMPLETED
Last Update Posted:
2023-02-24
First Post:
2021-02-03
Brief Title:
AN-PEP on Gluten Exposure in Celiacs
Sponsor:
Dr C Bonorino Udaondo Gastroenterology Hospital
Organization:
Dr C Bonorino Udaondo Gastroenterology Hospital
Study Overview
Official Title:
Effect of the Endopeptidase AN-PEP on Gluten Exposure in Real Life in Celiac Disease Patients Treated With a Long-term Gluten-free Diet Exploratory Interventional Prospective Controlled and Double Blind Study
Status:
COMPLETED
Status Verified Date:
2023-02
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 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
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
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 In a real-life study it was recently shown that 89 of treated CeD patients performing a strict diet have contact with dietary gluten at least one week per 4 weeks of testing and averaging 3 weeks per month Furthermore 40 of patients excreted gliadin immunogenic peptides GIP surrogated markers of gluten exposure in the range for immunological activation and intestinal mucosal damage Endopeptidases to produce a complete intraluminal proteolysis of gluten avoiding antigenic stimulation were produced to avoid damage of continuous gluten exposure AN-PEP is an Aspergillus niger derived endopeptidase has been produced aiming to luminal detoxification of gluten have been explored for its clinical effect However whether AN-PEP is able to completely destroy gluten in the context of the real life of CeD patients is still unknown Hypothesis The investigators estimate that AN-PEP is an effective therapy for proteolysis for gluten exposure in the real-life of CeD patients and that the effect could be detected by the reduction in the excretion of GIP in stool and urine based on a clinical research model that we developed AIMS to establish the effect of daily administration of AN-PEP compared to placebo in terms of 1 frequency of GIP excretion in stool and urine episodes in 4 weeks 2 concentration of GIP excretion for both arms and 3 differences in proportion of patients excreting GIP above the threshold for mucosal damage 2 µgg of GIP in stool or 12 ngmL in urine Study design Interventional prospective randomized comparative double-blind study Components 1- four-week GFD stabilization period 2-Randomization 3- four4-week study period Patients blinded-receive active AN-PEP GliadinX at a dose of 2 capsulesbreakfast lunch and dinner study arm or 2 capsules at same time points of placebo specially designed and prepared for the study Placebo arm
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
True
Is an FDA AA801 Violation?:
None