Use of a proline-specific endopeptidase to reintroduce gluten in patients with non-coeliac gluten sensitivity: A randomized trial.
Gastrointestinal symptoms
Gluten re-introduction
Gluten-free diet
Non-coeliac gluten sensitivity
Prolyl endoprotease
Journal
Clinical nutrition (Edinburgh, Scotland)
ISSN: 1532-1983
Titre abrégé: Clin Nutr
Pays: England
ID NLM: 8309603
Informations de publication
Date de publication:
09 2022
09 2022
Historique:
received:
22
03
2022
revised:
15
07
2022
accepted:
15
07
2022
pubmed:
17
8
2022
medline:
9
9
2022
entrez:
16
8
2022
Statut:
ppublish
Résumé
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. To evaluate the controlled reintroduction of gluten with or without the endopeptidase P1016 in NCGS patients. 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. 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. Our results demonstrate a lack of effect of P1016 in the management of NCGS patients and the possible reintroduction of gluten.
Sections du résumé
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.
Identifiants
pubmed: 35973395
pii: S0261-5614(22)00273-4
doi: 10.1016/j.clnu.2022.07.029
pii:
doi:
Substances chimiques
Glutens
8002-80-0
Proline
9DLQ4CIU6V
Prolyl Oligopeptidases
EC 3.4.21.26
Banques de données
ClinicalTrials.gov
['NCT01864993']
Types de publication
Journal Article
Randomized Controlled Trial
Research Support, Non-U.S. Gov't
Langues
eng
Sous-ensembles de citation
IM
Pagination
2025-2030Informations de copyright
Copyright © 2022 Elsevier Ltd and European Society for Clinical Nutrition and Metabolism. All rights reserved.
Déclaration de conflit d'intérêts
Conflict of interest The authors declare no conflict of interest.