{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,7,25]],"date-time":"2026-07-25T08:05:11Z","timestamp":1784966711247,"version":"3.55.0"},"reference-count":32,"publisher":"Baishideng Publishing Group Inc.","issue":"11","content-domain":{"domain":[],"crossmark-restriction":false},"short-container-title":["World J Gastroenterol"],"abstract":"BACKGROUND<\/jats:p>\n The gluten-free diet (GFD) has limitations, and there is intense research in the development of adjuvant therapies.<\/jats:p>\n AIM<\/jats:p>\n To 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.<\/jats:p>\n METHODS<\/jats:p>\n This 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.<\/jats:p>\n RESULTS<\/jats:p>\n Forty 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 \u03bcg\/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 \u03bcg\/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 \u03bcg\/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.<\/jats:p>\n CONCLUSION<\/jats:p>\n This 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.<\/jats:p>","DOI":"10.3748\/wjg.v30.i11.1545","type":"journal-article","created":{"date-parts":[[2024,3,21]],"date-time":"2024-03-21T06:04:56Z","timestamp":1711001096000},"page":"1545-1555","source":"Crossref","is-referenced-by-count":29,"title":["Effect of Aspergillus niger<\/i> prolyl endopeptidase in patients with celiac disease on a long-term gluten-free diet"],"prefix":"10.3748","volume":"30","author":[{"given":"Juan 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