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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
  1. Florencia Carbone1,2,
  2. Karen Van den Houte2,
  3. Linde Besard1,
  4. Céline Tack1,
  5. Joris Arts1,3,
  6. Philip Caenepeel1,3,
  7. Hubert Piessevaux4,
  8. Alain Vandenberghe5,
  9. Christophe Matthys6,
  10. Jessica Biesiekierski2,7,
  11. Luc Capiau8,
  12. Steven Ceulemans8,
  13. Olivier Gernay8,
  14. Lydia Jones8,
  15. Sophie Maes8,
  16. Christian Peetermans8,
  17. Willem Raat9,
  18. Jeroen Stubbe8,
  19. Rudy Van Boxstael8,
  20. Olivia Vandeput8,
  21. Sophie Van Steenbergen8,
  22. Lukas Van Oudenhove2,
  23. Tim Vanuytsel1,2,
  24. Michael Jones10,
  25. Jan Tack1,2,11,12
  26. DOMINO Study Collaborators
    1. 1Department of Gastroenterology, KU Leuven University Hospitals Leuven, Leuven, Belgium
    2. 2TARGID (Translational Research Center for Gastrointestinal Disorders), KU Leuven, Leuven, Belgium
    3. 3Gastroenterology, Ziekenhuis Oost-Limburg, Genk, Belgium
    4. 4Department of Gastroenterology and Hepatology, Université catholique de Louvain, Louvain-la-Neuve, Belgium
    5. 5Medical Research Laboratories International, Chaumont-Gistoux, Belgium
    6. 6Clinical and Experimental Endocrinology, Katholieke Universiteit Leuven, Leuven, Belgium
    7. 7Department of Dietetics, Nutrition and Sport, La Trobe University, Melbourne, Victoria, Australia
    8. 8Primary care physician, Domino primary care physician study group, Leuven, Belgium
    9. 9Department of Public Health and Primary Care, KU Leuven, Leuven, Belgium
    10. 10Faculty of Medicine, Health and Human Sciences, Macquarie University, Sydney, New South Wales, Australia
    11. 11Rome Foundation Research Institute, Raleigh, North Carolina, USA
    12. 12Rome Foundation, Raleigh, North Carolina, USA
    13. 13Domino Study Group, Leuven, Belgium
    1. Correspondence to Dr Jan Tack, Gastroenterology and Hepatology, KU Leuven University Hospitals Leuven, Leuven 3000, Belgium; jan.tack{at}med.kuleuven.ac.be

    Abstract

    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.

    • IRRITABLE BOWEL SYNDROME
    • QUALITY OF LIFE
    • PRIMARY CARE

    Data availability statement

    Data are available on reasonable request.

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    Data availability statement

    Data are available on reasonable request.

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    Footnotes

    • FC and KVdH are joint first authors.

    • 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.

    • Contributors FC: trial design, study coordination, data collection, analysis, manuscript drafting and reviewing. KVdH: study coordination, data collection, analysis, manuscript drafting and reviewing. LB: data collection, study follow-up, manuscript review. CT: data analysis, manuscript review. JA, PC, HP, AV: trial organisation support, manuscript review. CM: trial design, trial organisation support, manuscript review. JB: trial design, manuscript review. LC, SM, CP, WR, JS, RVB, OV, SVS: data collection, manuscript review. LVO, TV: manuscript review. MJ: trial design, data analysis, manuscript review. JT: trial concept, design, organisation, data collection, analysis, manuscript drafting, manuscript review and guarantor of the overall content of the article.

    • Funding The DOMINO study was funded through the Belgian Health Care Knowledge Centre (KCE) Trials Program (study ID KCE16001), a national public funding program of non-commercial trials. KCE provided feedback on the design and conduct of the study but was not involved in the collection, management, analysis or interpretation of the data. KCE provided comments on the drafted clinical study report and the manuscript for publication, but no publication restrictions apply. The Rome Foundation Research Institute provided diagnostic and patient-reported outcome questionnaires.

    • Competing interests JT has given Scientific advice to Alfa Wassermann, Allergan, Christian Hansen, Danone, Grünenthal, Ironwood, Janssen, Kiowa Kirin, Menarini, Mylan, Neutec, Novartis, Noventure, Nutricia, Shionogi, Shire, Takeda, Theravance, Tramedico, Truvion, Tsumura, Zealand and Zeria Pharmaceuticals, has received research support from Shire, Sofar and Tsumura, and has served on the Speaker Bureau for Abbott, Allergan, AstraZeneca, Janssen, Kyowa Kirin, Menarini, Mylan, Novartis, Shire, Takeda, Truvion and Zeria. Funding was provided by a Methusalem grant from Leuven University to JT. HP has given scientific advice to Allergan, Danone, Menarini, Merck Serono, Shire and Zeria and has served on the speaker Bureau of Menarini, Merck Serono, Shire and Zeria. LVO has given scientific advice to Danone and received research support from Nestlé. TV has given scientific advice to VectivBio, Shire, Dr. Falk Pharma, Takeda and Baxter; has received research support from Danone, MyHealth and VectivBio; and has served on the Speaker Bureau for Abbott, Tramedico, Truvion, Will Pharma, My Health, Kyowa Kirin, Menarini, Biocodex, Remedus, Fresenius Kabi and Dr. Falk Pharma. CM has served on the Speaker Bureau for Coca-Cola and Zespri and received travel/conference grants from Danone, Nestlé Health Sciences, Fresenius Kabi. This study was supported by a research grant from the Belgian Health Care Knowledge Centre (KCE). Questionnaires in this trial were developed, translated and provided by the Rome Foundation Research Institute.

    • Patient and public involvement Patients and/or the public were involved in the design, conduct, reporting or dissemination plans of this research. Refer to the Methods section for further details.

    • Provenance and peer review Not commissioned; externally peer reviewed.

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