Use of a proline-specific endopeptidase to reintroduce gluten in patients with non-coeliac gluten sensitivity: A randomized trial. Issue 9 (September 2022)

• Record Type: Journal Article
• Authors: Scricciolo, A.; Lombardo, V.; Elli, L.; Bascuñán, K.A.; Doneda, L.; Rinaldi, F.; Pinto, D.; Araya, M.; Costantino, A.; Vecchi, M.; Roncoroni, L.
• Is Part Of: Clinical nutrition. Volume 41:Issue 9(2022)
• Page Start: 2025
• Page End: 2030
• Publication Date: 2022-09
• Subjects: Gastrointestinal symptoms -- Gluten re-introduction -- Gluten-free diet -- Non-coeliac gluten sensitivity -- Prolyl endoprotease; Critically ill -- Nutrition -- Periodicals; Diet therapy -- Periodicals; Parenteral feeding -- Periodicals; Enteral feeding -- Periodicals; Enteral Nutrition -- Periodicals; Parenteral Nutrition -- Periodicals; Metabolism -- Periodicals; Diétothérapie -- Périodiques; Alimentation parentérale -- Périodiques; Alimentation entérale -- Périodiques; Nutrition -- Périodiques; Diet therapy; Enteral feeding; Nutrition; Parenteral feeding; Electronic journals; Periodicals; Electronic journals; 615.854
• DOI: 10.1016/j.clnu.2022.07.029
• Languages: English
• ISSNs: 0261-5614

Abstract

Summary: Background: A gluten-free diet (GFD) is the main therapy for non-coeliac gluten sensitivity (NCGS). However, the availability of novel enzymes with the ability to digest gluten could represent a therapeutic opportunity for NCGS patients to avoid a GFD. Aims: To evaluate the controlled reintroduction of gluten with or without the endopeptidase P1016 in NCGS patients. Methods: This is a randomized, double-blind, placebo-controlled monocentric study, Registered under ClinicalTrials.gov Identifier no. NCT01864993. Gluten was reintroduced incrementally over a 3-week period under nutritional control. NCGS patients were randomized into two groups and administered P1016 or placebo during gluten reintroduction. We evaluated symptoms (visual analogue scale, VAS), quality of life (SF-36) and mental health symptoms (SCL-90) on a weekly basis. Results: We enrolled a total 23 patients who were allocated to a placebo group (n = 11, age 38.4 ± 2.9) or an intervention group (n = 12, age 39.5 ± 3.1). No effect of P1016 on symptoms was found. During gluten reintroduction, patients reported a significant increase in abdominal pain and a worsening of stool consistency. Furthermore, no differences were found between the groups regarding SCL-90 and SF-36 scores. Conclusions: Our results demonstrate a lack of effect of P1016 in the management of NCGS patients and the possible reintroduction of gluten.