Phenotyping of subjects for large scale studies on patients with IBS.

G E Boeckxstaens, V Drug, D Dumitrascu, A D Farmer, J Hammer, T Hausken, B Niesler, D Pohl, L Pojskic, A Polster, M Simren, M Goebel-Stengel, L Van Oudenhove, M Vassallo, K-A Wensaas, Q Aziz, L A Houghton

Journal: Neurogastroenterology and motility 2018;28(8):1134-47

PMID: 27319981

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Abstract

BACKGROUND

Irritable bowel syndrome (IBS) is a complex condition with multiple factors contributing to its aetiology and pathophysiology. Aetiologically these include genetics, life-time events and environment, and physiologically, changes in motility, central processing, visceral sensitivity, immunity, epithelial permeability and gastrointestinal microflora. Such complexity means there is currently no specific reliable biomarker for IBS, and thus IBS continues to be diagnosed and classified according to symptom based criteria, the Rome Criteria. Carefully phenotyping and characterisation of a 'large' pool of IBS patients across Europe and even the world however, might help identify sub-populations with accuracy and consistency. This will not only aid future research but improve tailoring of treatment and health care of IBS patients.

PURPOSE

The aim of this position paper is to discuss the requirements necessary to standardize the process of selecting and phenotyping IBS patients and how to organise the collection and storage of patient information/samples in such a large multi-centre pan European/global study. We include information on general demographics, gastrointestinal symptom assessment, psychological factors, quality of life, physiological evaluation, genetic/epigenetic and microbiota analysis, biopsy/blood sampling, together with discussion on the organisational, ethical and language issues associated with implementing such a study. The proposed approach and documents selected to be used in such a study was the result of a thoughtful and thorough four-year dialogue amongst experts associated with the European COST action BM1106 GENIEUR (www.GENIEUR.eu).

Address: Translational Research Center for Gastrointestinal Disorders, KULeuven & Department of Gastroenterology and Hepatology, University Hospital Leuven, Leuven, Belgium.; Gastroenterology Department, University Hospital "St Spiridon", Gr. T.Popa University of Medicine and Pharmacy, Iasi, Romania.; 2nd Medical Dept., Iuliu Hatieganu University of Medicine and Pharmacy, Cluj-Napoca, Romania.; Wingate Institute of Neurogastroenterology, Barts and The London School of Medicine and Dentistry, London, UK.; Department of Gastroenterology, University Hospitals of North Midlands, Stoke on Trent, UK.; Medizinische Universität Wien, Universitätsklinik für Innere Medizin 3, Vienna, Austria.; Department of Medicine, Unit of Gastroenterology, Haukeland University Hospital, Bergen, Norway.; Department of Human Molecular Genetics, University of Heidelberg, Heidelberg, Germany.; Division of Gastroenterology and Hepatology, University Hospital Zurich, Zurich, Switzerland.; Institute for Genetic Engineering and Biotechnology, University of Sarajevo, Sarajevo, Bosnia and Herzegovina.; Department of Internal Medicine and Clinical Nutrition, Institute of Medicine, Sahlgrenska Academy, University of Gothenburg, Gothenburg, Sweden.; Department of Internal Medicine and Clinical Nutrition, Institute of Medicine, Sahlgrenska Academy, University of Gothenburg, Gothenburg, Sweden.; Center for Functional Gastrointestinal and Motility Disorders, University of North Carolina at Chapel Hill, Chapel Hill, NC, USA.; Department of Internal Medicine, Martin-Luther-Krankenhaus, Berlin, Germany.; Department of Medicine, Mater Dei Hospital, Tal-Qroqq, Malta.; Uni Research Health, Research Unit for General Practice, Bergen, Norway.; Wingate Institute of Neurogastroenterology, Barts and The London School of Medicine and Dentistry, London, UK.; Leeds Institute of Biomedical and Clinical Sciences, University of Leeds and Leeds Gastroenterology Institute, Leeds Teaching Hospitals Trust, Leeds, UK.; Centre for Gastrointestinal Sciences, University of Manchester, Manchester, UK.; Division of Gastroenterology and Hepatology, Mayo Clinic, Jacksonville, FL, USA.

DOI: 10.1111/nmo.12886

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MeSH Terms: Humans, Irritable Bowel Syndrome, Patient Selection, Phenotype, Quality of Life, Research Subjects