Producción CyT
Effect of AN-PEP protease in patients with celiac disease on a long-term gluten-free diet
Artículo
Autoría:
STEFANOLO, J.P. ; SEGURA, V. ; GRITUZZI, M. ; HEREDIA, A. ; COMINO, I. ; COSTA, A.F. ; PUEBLA, R. ; TEMPRANO, M.P. ; NIVELONI, S.I. ; DE DIEGO, GABRIEL ALEJANDRO ; OREGUI, M.E. ; SMECUOL, E.G. ; DE MARZI, M.C. ; VERDÚ, E.F. ; SOUSA, C. ; BAI, J.C.Fecha:
2024Editorial y Lugar de Edición:
W J G PRESSRevista:
WORLD JOURNAL OF GASTROENTEROLOGY W J G PRESSResumen *
BACKGROUNDThe gluten-free diet (GFD) has limitations, and there is intense research in the development of adjuvant therapies.AIMTo examine the effects of orally administered Aspergillus niger prolyl endopeptidase protease (AN-PEP) on inadvertent gluten exposure and symptom prevention in adult celiac disease (CeD) patients following their usual GFD.METHODSThis was an exploratory, double-blind, randomized, placebo-controlled trial that enrolled CeD patients on a long-term GFD. After a 4-wk run-in period, patients were randomized to 4 wk of two AN-PEP capsules (GliadinX; AVI Research, LLC, United States) at each of three meals per day or placebo. Outcome endpoints were: (1) Average weekly stool gluten immunogenic peptides (GIP) between the run-in and end of treatments and between AN-PEP and placebo; (2) celiac symptom index (CSI); (3) CeD-specific serology; and (4) quality of life. Stool samples were collected for GIP testing by ELISA every Tuesday and Friday during run-ins and treatments.RESULTSForty patients were randomized for the intention-to-treat analysis, and three were excluded from the per-protocol assessment. Overall, 628/640 (98.1%) stool samples were collected. GIP was undetectable (< 0.08 μg/g) in 65.6% of samples, and no differences between treatment arms were detected. Only 0.5% of samples had GIP concentrations sufficiently high (> 0.32 μg/g) to potentially cause mucosal damage. Median GIP concentration in the AN-PEP arm was 44.7% lower than in the run-in period. One-third of patients exhibiting GIP > 0.08 μg/g during run-in had lower or undetectable GIP after AN-PEP treatment. Compared with the run- in period, the proportion of symptomatic patients (CSI > 38) in the AN-PEP arm was significantly lower (P < 0.03). AN-PEP did not result in changes in specific serologies.CONCLUSIONThis exploratory study conducted in a real-life setting revealed high adherence to the GFD. The AN-PEP treatment did not significantly reduce the overall GIP stool concentration. However, given the observation of a significantly lower prevalence of patients with severe symptoms in the AN-PEP arm, further clinical research is warranted. Información suministrada por el agente en SIGEVAPalabras Clave
GLUTENAN-PEPASPERGILLUSCELIAC