PDF | https://doi.org/10.46613/congastro2023-60
This work is licensed under CC BY 4.0
Stefanolo J1, Segura V2, Grizutti M1, Heredia A2, Comino I2, Costa A1, Puebla R1, Temprano M1, Niveloni S1, de Diego G3, Oregui M1, SMECUOL E1, De Marzi M3, Verdú E4, Bai J5
1Hospital de Gastroenterología “Dr. C. Bonorino Udaondo”, Buenos Aires, Argentina
2University of Seville, Sevilla, España
3National University of Lujan, Luján, Argentina
4Mc Master University, Hamilton, Canadá
5Del Salvador University, Buenos Aires, Argentina
Background/Aim: To examine the effects of orally administered Aspergillus niger endopeptidase (AN-PEP) on inadvertent gluten exposure and symptom prevention in real-life patients with celiac disease (CeD) consuming a gluten-free diet (GFD).
Methods: This exploratory, double-blind, randomized, placebo-controlled trial enrolled patients with CeD. After four-week run-in period, patients were randomized to 4-week treatment with 2 AN-PEP capsules at each of 3 meals/day, or placebo. AN-PEP capsule contained 325 mg of 70% AN-PEP (GliadinX. AVI Research LLC; USA). Outcome endpoints were the changes in 1- the stool gluten immunogenic peptides (GIP) concentrations; 2- the Celiac Symptom Index (CSI); 3- CeD-specific serology and, 4- the quality of life. During run-ins and treatments, samples were collected for GIP measurement by ELISA (Biomedal S.L., Seville, Spain) every Tuesday and Friday.
Results: 40 patients were randomized to the intention-to-treat analysis. Overall, 628/640 (98.1%) possible stool samples were collected. GIP was undetectable (<0.08 µg/g) in 65.6% of samples without differing arms. Only 0.5% of samples had isolated stool GIP concentrations sufficiently high (0.32µg/g) to cause mucosal damage potentially. Compared with the run-in period, the median GIP concentration in the AN-PEP arm was 44.7% lower after treatment. Furthermore, 35.6% of patients in AN-PEP had an average stool GIP 0.180 µg/g reduced (50% of run-in concentrations) or exhibited undetectable GIP after treatment. The AN-PEP significantly reduced the proportion of patients with a CSI 38 (severe symptoms) compared to the run-in (McNemar: p<0.03). Treatments did not detect changes in the specific serology.
Conclusions: This exploratory study, conducted in a real-life setting, revealed that patients exhibited high adherence to the GFD. Specifically, patients with an average stool GIP 180 µg/g during the run-in period experienced reduced gluten exposure when consuming AN-PEP and a significantly lower prevalence of more severe symptomatic cases by AN-PEP treatment.