使用脯氨酸特异性内肽酶使非乳糜泻麸质敏感性患者重新摄入麸质：一项随机试验。

Use of a proline-specific endopeptidase to reintroduce gluten in patients with non-coeliac gluten sensitivity: A randomized trial.

机构信息

Center for Prevention and Diagnosis of Celiac Disease, Gastroenterology and Endoscopy Unit, Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico, Milan, Italy.

Center for Prevention and Diagnosis of Celiac Disease, Gastroenterology and Endoscopy Unit, Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico, Milan, Italy; Department of Pathophysiology and Transplantation, University of Milan, Milan, Italy.

出版信息

Clin Nutr. 2022 Sep;41(9):2025-2030. doi: 10.1016/j.clnu.2022.07.029. Epub 2022 Jul 31.

DOI:10.1016/j.clnu.2022.07.029

PMID:35973395

Abstract

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.

摘要

背景

无麸质饮食（GFD）是治疗非麸质敏感性肠病（NCGS）的主要方法。然而，具有消化麸质能力的新型酶的出现为 NCGS 患者提供了一种避免 GFD 的治疗机会。

目的

评估新型内肽酶 P1016 在 NCGS 患者中添加或不添加麸质时的控制再引入效果。

方法

这是一项随机、双盲、安慰剂对照的单中心研究，在 ClinicalTrials.gov 注册号 NCT01864993 下注册。在营养控制下，用 3 周的时间逐步重新引入麸质。NCGS 患者随机分为两组，在重新引入麸质期间分别给予 P1016 或安慰剂。我们每周评估症状（视觉模拟评分，VAS）、生活质量（SF-36）和心理健康症状（SCL-90）。

结果

我们共纳入了 23 名患者，其中 11 名患者被分配到安慰剂组（年龄 38.4 ± 2.9），12 名患者被分配到干预组（年龄 39.5 ± 3.1）。未发现 P1016 对症状有影响。在重新引入麸质期间，患者报告腹痛明显增加，粪便稠度恶化。此外，两组在 SCL-90 和 SF-36 评分方面无差异。