Prospective, double-blind diagnostic multicentre study of confocal laser endomicroscopy for wheat sensitivity in patients with irritable bowel syndrome.

Autor:	Bojarski C; Charité - Universitätsmedizin Berlin, Corporate member of Freie Universität Berlin, Humboldt-Universität zu Berlin and Berlin Institute of Health, Campus Benjamin Franklin, Department for Internal Medicine (Gastroenterology, Infectious Diseases, Rheumatology, Berlin, Germany christian.bojarski@charite.de., Tangermann P; Charité - Universitätsmedizin Berlin, Corporate member of Freie Universität Berlin, Humboldt-Universität zu Berlin and Berlin Institute of Health, Campus Benjamin Franklin, Department for Internal Medicine (Gastroenterology, Infectious Diseases, Rheumatology, Berlin, Germany., Barmeyer C; Charité - Universitätsmedizin Berlin, Corporate member of Freie Universität Berlin, Humboldt-Universität zu Berlin and Berlin Institute of Health, Campus Benjamin Franklin, Department for Internal Medicine (Gastroenterology, Infectious Diseases, Rheumatology, Berlin, Germany., Buchkremer J; Charité - Universitätsmedizin Berlin, Corporate member of Freie Universität Berlin, Humboldt-Universität zu Berlin and Berlin Institute of Health, Campus Benjamin Franklin, Department for Internal Medicine (Gastroenterology, Infectious Diseases, Rheumatology, Berlin, Germany., Kiesslich R; Helios Dr. Horst Schmidt Kliniken Wiesbaden, Internal Medicine II Gastroenterology, Hepatology and Endocrinology, Wiesbaden, Germany., Ellrichmann M; Universitätsklinikum Schleswig-Holstein, Medical Department I, Kiel, Germany., Schreiber S; Universitätsklinikum Schleswig-Holstein, Medical Department I, Kiel, Germany., Schmidt C; Universitätsklinikum Jena, Department of Internal Medicine IV (Gastroenterology, Hepatology and Infectious Diseases), Jena, Germany.; Klinikum Fulda, Medical Clinic II, Fulda, Germany., Stallmach A; Universitätsklinikum Jena, Department of Internal Medicine IV (Gastroenterology, Hepatology and Infectious Diseases), Jena, Germany., Roehle R; Charité - Universitätsmedizin Berlin, Institute of Biometry and Clinical Epidemiology, Berlin, Germany.; Charité - Universitätsmedizin Berlin, Clinical Study Center, Berlin, Germany.; Berlin Institute of Health (BIH), Berlin, Germany., Loddenkemper C; Institute of Pathology, PathoTres, Berlin, Germany., Daum S; Charité - Universitätsmedizin Berlin, Corporate member of Freie Universität Berlin, Humboldt-Universität zu Berlin and Berlin Institute of Health, Campus Benjamin Franklin, Department for Internal Medicine (Gastroenterology, Infectious Diseases, Rheumatology, Berlin, Germany., Siegmund B; Charité - Universitätsmedizin Berlin, Corporate member of Freie Universität Berlin, Humboldt-Universität zu Berlin and Berlin Institute of Health, Campus Benjamin Franklin, Department for Internal Medicine (Gastroenterology, Infectious Diseases, Rheumatology, Berlin, Germany., Schumann M; Charité - Universitätsmedizin Berlin, Corporate member of Freie Universität Berlin, Humboldt-Universität zu Berlin and Berlin Institute of Health, Campus Benjamin Franklin, Department for Internal Medicine (Gastroenterology, Infectious Diseases, Rheumatology, Berlin, Germany., Ullrich R; Charité - Universitätsmedizin Berlin, Corporate member of Freie Universität Berlin, Humboldt-Universität zu Berlin and Berlin Institute of Health, Campus Benjamin Franklin, Department for Internal Medicine (Gastroenterology, Infectious Diseases, Rheumatology, Berlin, Germany.
Jazyk:	angličtina
Zdroj:	Gut [Gut] 2022 Aug; Vol. 71 (8), pp. 1567-1576. Date of Electronic Publication: 2021 Sep 20.
DOI:	10.1136/gutjnl-2021-325181
Abstrakt:	Objective: A considerable proportion of patients with irritable bowel syndrome (IBS) may be wheat-sensitive and respond to a gluten-free diet (GFD) although they do not have coeliac disease. However, a diagnostic test for wheat sensitivity (WS) is missing. Our study evaluated the diagnostic accuracy (sensitivity and specificity) of confocal laser endomicroscopy (CLE) for the identification of WS as primary outcome. Design: In this prospective, double-blind diagnostic study 147 non-coeliac patients fulfilling the Rome III criteria for IBS were tested by CLE for duodenal changes after wheat (index test), soy, yeast or milk exposure. Patients with IBS responding to 2 months of GFD were classified as having WS (reference test) using response criteria recommended by regulatory bodies for pharmaceutical trials of patients with IBS. After 2 months, CLE results were unblinded and patients were advised to exclude those food components that had led to a positive CLE reaction. The clinical response was assessed at follow-up after 6 and 12 months. Results: Of 130 patients who completed the study per protocol, 74 (56.9%) responded to GFD and were classified as WS after 2 months, and 38 of these 74 patients were correctly identified by CLE (sensitivity 51.4%; 97.5% CI: 38.7% to 63.9%). A total of 38 of 56 patients without WS were correctly identified by CLE (specificity 67.9%; 97.5% CI: 52.9% to 79.9%). At 6 months follow-up, CLE correctly identified 49 of 59 food-sensitive patients (sensitivity 83.1%; 97.5% CI: 69.9% to 91.3%) but specificity was only 32% (97.5% CI: 15.7% to 54.3%). Conclusion: In light of the high proportion of patients with IBS responding to GFD, the diagnostic accuracy of CLE is too low to recommend widespread use of this invasive procedure. Trail Registration Number: This study was registered as clinical trial in the German Registry for Clinical Studies (DRKS00010123). Competing Interests: Competing interests: CBo, MS and RU received research grants from Dr. Schär AG. ME obtained consulting and lecture fees from Maunakeatech, Boston Scientific, Takeda, Abbvie, Janssen. CS received research grants and lecture fees from Olympus and Pentax. AS obtained consulting fees from Abbvie, Amgen, Astellas, Biogen, Celltrion, Consal, CSL Behring, Galapagos, Gilead, Institut Allergosan, Janssen, MSD, Norgine, Pfizer Pharma, Roche, Shire and Takeda, lecture fees and travel support from Abbvie, Astellas, Celltrion, Falk Foundation, Ferring, Janssen, MSD, Recordati Pharma and Takeda, and research support from Abbvie. SD obtained lecture fees from BMS, Recordati, Amgen and Falk. BS has served as consultant for Abbvie, Arena, BMS, Boehringer, Celgene, Falk, Janssen, Lilly, Pfizer, Prometheus and Takeda and received speaker’s fees from Abbvie, CED Service, Falk, Ferring, Janssen, Novartis, Pfizer, Takeda (served as representative of the Charité). (© Author(s) (or their employer(s)) 2022. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ.)
Databáze:	MEDLINE
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