- Fecal Incontinence
|Diet or medication in primary care patients with IBS: the DOMINO study - a randomised trial supported by the Belgian Health Care Knowledge Centre (KCE Trials Programme) and the Rome Foundation Research Institute
Gut. 2022 Nov;71(11):2226-2232.doi: 10.1136/gutjnl-2021-325821. Epub 2022 Apr 28.
Florencia Carbone 1 2, Karen Van den Houte 2, Linde Besard 1, Céline Tack 1, Joris Arts 1 3, Philip Caenepeel 1 3, Hubert Piessevaux 4, Alain Vandenberghe 5, Christophe Matthys 6, Jessica Biesiekierski 2 7, Luc Capiau 8, Steven Ceulemans 8, Olivier Gernay 8, Lydia Jones 8, Sophie Maes 8, Christian Peetermans 8, Willem Raat 9, Jeroen Stubbe 8, Rudy Van Boxstael 8, Olivia Vandeput 8, Sophie Van Steenbergen 8, Lukas Van Oudenhove 2, Tim Vanuytsel 1 2, Michael Jones 10, Jan Tack 11 2 12 13, DOMINO Study Collaborators; Domino Study Collaborators
Alain Goorden, Alegonda Snijkers, An Leys, Annemiek Roelofs, Bart Schoolmeesters, Bart Vander Putten, Benjamin Van den Broek, Birgitta Baade-Joret, Céline Huberlant, Christian Peetermans, David Van Humbeek, Dirk Van den Brande, Dirk Wyseyr, Els Lemmens, Ethel Brits, Guido Simons, Hans Baetens, Hendrika Van Overmeire, Hilde Tack, Ilse Cupers, Ive Talboom, Jeroen Stubbe, Jonas Docx, Judith Deseins, Julie Biot, Julie Vancaillie, Kara Vandeloo, Karlijn Louwies, Karolien De Ceulaer, Karolien Lemmens, Katrien Scheers, Leen Verleure, Lies De Sutter, Lies Plancke, Liesbet Bruyninckx, Liesbeth Vanzeir, Lieve Vandersmisse, Linde Wyseur, Lode Vermeersch, Lodewijk Pas, Lore De Greef, Luc Capiau, Luc Van Braeckel, Lut De Groote, Lydia Jones, Maria Groot, Marianne Busschots, Marie-Hélène Landenne, Marieke Monstrey, Marie-Magdalena Haemels, Marleen Snellings, Maura Sisk, Nathalie Van de Vyver, Nikea Sannen, Olivia Vandeput, Olivier Gernay, Philippe Thoné, Phouthalack Narongsack, Pierre Vrins, Pieterjan Geusens, Rik Sauwens, Rudy Van Boxstael, Sigrid Musch, Sigrid Nous, Sofie Mazereel, Sophie Maes, Sophie Van Steenbergen, Stéphanie Biot, Steven Ceulemans, Stijn Geeraert, Tine Caeyers, Vincent Vanbelle, Willem Raat
1Department of Gastroenterology, KU Leuven University Hospitals Leuven, Leuven, Belgium.
2TARGID (Translational Research Center for Gastrointestinal Disorders), KU Leuven, Leuven, Belgium.
3Gastroenterology, Ziekenhuis Oost-Limburg, Genk, Belgium.
4Department of Gastroenterology and Hepatology, Université catholique de Louvain, Louvain-la-Neuve, Belgium.
5Medical Research Laboratories International, Chaumont-Gistoux, Belgium.
6Clinical and Experimental Endocrinology, Katholieke Universiteit Leuven, Leuven, Belgium.
7Department of Dietetics, Nutrition and Sport, La Trobe University, Melbourne, Victoria, Australia.
8Primary care physician, Domino primary care physician study group, Leuven, Belgium.
9Department of Public Health and Primary Care, KU Leuven, Leuven, Belgium.
10Faculty of Medicine, Health and Human Sciences, Macquarie University, Sydney, New South Wales, Australia.
11Department of Gastroenterology, KU Leuven University Hospitals Leuven, Leuven, Belgium email@example.com.
12Rome Foundation Research Institute, Raleigh, North Carolina, USA.
13Rome Foundation, Raleigh, North Carolina, USA.
Background: In Europe, IBS is commonly treated with musculotropic spasmolytics (eg, otilonium bromide, OB). In tertiary care, a low fermentable oligosaccharides, disaccharides, monosaccharides and polyols (FODMAP) diet provides significant improvement. Yet, dietary treatment remains to be explored in primary care. We evaluated the effect of a smartphone FODMAP-lowering diet application versus OB on symptoms in primary care IBS.
Methods: IBS patients, recruited by primary care physicians, were randomised to 8 weeks of OB (40 mg three times a day) or diet and followed for 24 weeks. We compared IBS Symptom Severity Score and the proportion of responders (improvement ≥50 points) in all patients and the subgroup fulfilling Rome IV criteria (Rome+). We also evaluated treatment efficacy, quality of life, anxiety, depression, somatic symptom severity (Patient Health Questionnaire (PHQ15, PHQ9)) and treatment adherence and analysed predictors of response.
Results: 459 primary care IBS patients (41±15 years, 76% female, 70% Rome+) were randomised. The responder rate after 8 weeks was significantly higher with diet compared with OB (71% (155/218) vs 61% (133/217), p=0.03) and more pronounced in Rome+ (77% (118/153) vs 62% (98/158), p=0.004). Patients allocated to diet (199/212) were 94% adherent compared with 73% with OB (148/202) (p<0.001). The significantly higher response rate with diet was already observed after 4 weeks (62% (132/213) vs 51% (110/215), p=0.02) and a high symptom response persisted during follow-up. Predictors of response were female gender (OR=2.08, p=0.04) for diet and PHQ15 (OR=1.10, p=0.02) for OB.
Conclusion: In primary care IBS patients, a FODMAP-lowering diet application was superior to a spasmolytic agent in improving IBS symptoms. A FODMAP-lowering diet should be considered the first-line treatment for IBS in primary care.
Trial registration number: NCT04270487.