Study protocol to investigate the efficacy of confocal laser endomicroscopy-based selective single-elimination diet over standard fivefold elimination diet in patients with endomicroscopically proven food intolerance: app-assisted, monocentric, double-blind, randomised and controlled trial in Germany

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dc.contributor.authorHeßler, Nicole
dc.contributor.authorKordowski, Anna
dc.contributor.authorSasse, Jill
dc.contributor.authorAhlemann, Greta
dc.contributor.authorSchulz, Franziska
dc.contributor.authorSchröder, Torsten
dc.contributor.authorExner, Anna
dc.contributor.authorJablonski, Lennart
dc.contributor.authorJappe, Uta
dc.contributor.authorBischoff, Stephan C
dc.contributor.authorGrzegorzek, Marcin
dc.contributor.authorKönig, Inke R
dc.contributor.authorSina, Christian
dc.date.accessioned2024-08-19T12:58:37Z
dc.date.available2024-08-19T12:58:37Z
dc.date.issued2023de
dc.description.abstractIntroduction: Imprecise nutritional recommendations due to a lack of diagnostic test accuracy are a frequent problem for individuals with adverse reactions to foods but no precise diagnosis. Consequently, patients follow very broad and strict elimination diets to avoid uncontrolled symptoms such as diarrhoea and abdominal pain. Dietary limitations and the uncertainty of developing gastrointestinal symptoms after the inadvertent ingestion of food have been demonstrated to reduce the quality of life (QoL) of affected individuals and subsequently might increase the risk of malnutrition and intestinal dysbiosis. This trial aims to investigate the effects of a tailored diet based on the confocal laser endoscopy (CLE) examination result to limit the side effects of unspecific and broad elimination diets and to increase the patient’s QoL. Methods and analysis: The study is designed as a prospective, double-blind, monocentric, randomised and controlled trial conducted at the University Hospital of Schleswig-Holstein, Campus Lübeck, Germany. One hundred seventy-two patients with non-IgE-related food allergies and positive CLE results will be randomised to either a tailored diet or a standard fivefold elimination diet. The primary endpoints are the difference between the end and the start of the intervention in health-related QoL and the sum score of the severity of symptoms after 12 weeks. Key secondary endpoints are changes in the severity of symptoms, further QoL measurements, self-assessed state of health and number of days with a pathologically altered stool. Microbiome diversity and metabolome of stool, urine and blood will also be investigated. Safety endpoints are body composition, body mass index and adverse events. Ethics and dissemination: The study protocol was accepted by the ethical committee of the University of Lübeck (AZ: 22-111) on 4 May2022. Results of the study will be published in peer-reviewed journals and presented at scientific meetings. Trial registration number: German Clinical Trials Register (DRKS00029323).en
dc.identifier.urihttps://hohpublica.uni-hohenheim.de/handle/123456789/16118
dc.identifier.urihttps://doi.org/10.1136/bmjopen-2023-072024
dc.language.isoengde
dc.rights.licensecc_by-ncde
dc.source2044-6055de
dc.sourceBMJ Open; Vol. 13, No. 11 (2023) e072024de
dc.titleStudy protocol to investigate the efficacy of confocal laser endomicroscopy-based selective single-elimination diet over standard fivefold elimination diet in patients with endomicroscopically proven food intolerance: app-assisted, monocentric, double-blind, randomised and controlled trial in Germanyen
dc.type.diniArticle
dcterms.bibliographicCitationBMJ open, 13 (2023), 11, e072024. https://doi.org/10.1136/bmjopen-2023-072024. ISSN: 2044-6055
dcterms.bibliographicCitation.issn2044-6055
dcterms.bibliographicCitation.issue11
dcterms.bibliographicCitation.journaltitleBMJ open
dcterms.bibliographicCitation.volume13
local.export.bibtex@article{Heßler2023, url = {https://hohpublica.uni-hohenheim.de/handle/123456789/16118}, doi = {10.1136/bmjopen-2023-072024}, author = {Heßler, Nicole and Kordowski, Anna and Sasse, Jill et al.}, title = {Study protocol to investigate the efficacy of confocal laser endomicroscopy-based selective single-elimination diet over standard fivefold elimination diet in patients with endomicroscopically proven food intolerance: app-assisted, monocentric, double-blind, randomised and controlled trial in Germany}, journal = {BMJ open}, year = {2023}, volume = {13}, number = {11}, }
local.export.bibtexAuthorHeßler, Nicole and Kordowski, Anna and Sasse, Jill et al.
local.export.bibtexKeyHeßler2023
local.export.bibtexType@article

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