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

Florencia Carbone; Karen Van Den Houte; Linde Besard; Céline Tack; Joris Arts; Philip Caenepeel; Hubert Piessevaux; Alain Vandenberghe; Christophe Matthys; Jessica Biesiekierski; Luc Capiau; Steven Ceulemans; Olivier Gernay; Lydia Jones; Sophie Maes; Christian Peetermans; Willem Raat; Jeroen Stubbe; Rudy Van Boxstael; Olivia Vandeput; Sophie Van Steenbergen; Lukas Van Oudenhove; Tim Vanuytsel; Michael Jones; Jan Tack; DOMINO Study Collaborators; Pierre Vrins

doi:10.1136/gutjnl-2021-325821

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

Florencia Carbone, Karen Van Den Houte, Linde Besard, Céline Tack, Joris Arts, Philip Caenepeel, Hubert Piessevaux, Alain Vandenberghe, Christophe Matthys, Jessica Biesiekierski, Luc Capiau, Steven Ceulemans, Olivier Gernay, Lydia Jones, Sophie Maes, Christian Peetermans, Willem Raat, Jeroen Stubbe, Rudy Van Boxstael, Olivia VandeputSophie Van Steenbergen, Lukas Van Oudenhove, Tim Vanuytsel, Michael Jones, Jan Tack^*, DOMINO Study Collaborators, Pierre Vrins

^*Corresponding author for this work

School of Psychological Sciences

Research output: Contribution to journal › Article › peer-review

42 Citations (Scopus)

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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.

Original language	English
Pages (from-to)	2226-2232
Number of pages	7
Journal	Gut
Volume	71
Issue number	11
DOIs	https://doi.org/10.1136/gutjnl-2021-325821
Publication status	Published - Nov 2022

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Copyright the Author(s) 2022. Version archived for private and non-commercial use with the permission of the author/s and according to publisher conditions. For further rights please contact the publisher.

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Carbone, F., Van Den Houte, K., Besard, L., Tack, C., Arts, J., Caenepeel, P., Piessevaux, H., Vandenberghe, A., Matthys, C., Biesiekierski, J., Capiau, L., Ceulemans, S., Gernay, O., Jones, L., Maes, S., Peetermans, C., Raat, W., Stubbe, J., Van Boxstael, R., ... Vrins, P. (2022). 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, 71(11), 2226-2232. https://doi.org/10.1136/gutjnl-2021-325821

@article{efa97ee0031f4349a6bb0310e0d2f6cf,

title = "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",

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.",

author = "Florencia Carbone and {Van Den Houte}, Karen and Linde Besard and C{\'e}line Tack and Joris Arts and Philip Caenepeel and Hubert Piessevaux and Alain Vandenberghe and Christophe Matthys and Jessica Biesiekierski and Luc Capiau and Steven Ceulemans and Olivier Gernay and Lydia Jones and Sophie Maes and Christian Peetermans and Willem Raat and Jeroen Stubbe and {Van Boxstael}, Rudy and Olivia Vandeput and {Van Steenbergen}, Sophie and {Van Oudenhove}, Lukas and Tim Vanuytsel and Michael Jones and Jan Tack and {DOMINO Study Collaborators} and Alain Goorden and Alegonda Snijkers and An Leys and Annemiek Roelofs and Bart Schoolmeesters and {Vander Putten}, Bart and {Van den Broek}, Benjamin and Birgitta Baade-Joret and C{\'e}line Huberlant and {Van Humbeek}, David and {Van den Brande}, Dirk and Dirk Wyseyr and Els Lemmens and Ethel Brits and Guido Simons and Hans Baetens and {Van Overmeire}, Hendrika and Hilde Tack and Ilse Cupers and Ive Talboom and Jonas Docx and Judith Deseins and Julie Biot and Julie Vancaillie and Kara Vandeloo and Karlijn Louwies and {De Ceulaer}, Karolien and Karolien Lemmens and Katrien Scheers and Leen Verleure and {De Sutter}, Lies and Lies Plancke and Liesbet Bruyninckx and Liesbeth Vanzeir and Lieve Vandersmisse and Linde Wyseur and Lode Vermeersch and Lodewijk Pas and {De Greef}, Lore and {Van Braeckel}, Luc and {De Groote}, Lut and Maria Groot and Marianne Busschots and Marie-H{\'e}l{\`e}ne Landenne and Marieke Monstrey and Marie-Magdalena Haemels and Marleen Snellings and Maura Sisk and {Van de Vyver}, Nathalie and Nikea Sannen and Philippe Thon{\'e} and Phouthalack Narongsack and Pierre Vrins and Pieterjan Geusens and Rik Sauwens and Sigrid Musch and Sigrid Nous and Sofie Mazereel and St{\'e}phanie Biot and Stijn Geeraert and Tine Caeyers and Vincent Vanbelle",

note = "Copyright the Author(s) 2022. Version archived for private and non-commercial use with the permission of the author/s and according to publisher conditions. For further rights please contact the publisher. ",

year = "2022",

month = nov,

doi = "10.1136/gutjnl-2021-325821",

language = "English",

volume = "71",

pages = "2226--2232",

journal = "Gut",

issn = "0017-5749",

publisher = "BMJ Publishing Group",

number = "11",

}

Carbone, F, Van Den Houte, K, Besard, L, Tack, C, Arts, J, Caenepeel, P, Piessevaux, H, Vandenberghe, A, Matthys, C, Biesiekierski, J, Capiau, L, Ceulemans, S, Gernay, O, Jones, L, Maes, S, Peetermans, C, Raat, W, Stubbe, J, Van Boxstael, R, Vandeput, O, Van Steenbergen, S, Van Oudenhove, L, Vanuytsel, T, Jones, M, Tack, J, DOMINO Study Collaborators & Vrins, P 2022, '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, vol. 71, no. 11, pp. 2226-2232. https://doi.org/10.1136/gutjnl-2021-325821

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. / Carbone, Florencia; Van Den Houte, Karen; Besard, Linde et al.
In: Gut, Vol. 71, No. 11, 11.2022, p. 2226-2232.

Research output: Contribution to journal › Article › peer-review

TY - JOUR

T1 - Diet or medication in primary care patients with IBS

T2 - The DOMINO study - a randomised trial supported by the Belgian Health Care Knowledge Centre (KCE Trials Programme) and the Rome Foundation Research Institute

AU - Carbone, Florencia

AU - Van Den Houte, Karen

AU - Besard, Linde

AU - Tack, Céline

AU - Arts, Joris

AU - Caenepeel, Philip

AU - Piessevaux, Hubert

AU - Vandenberghe, Alain

AU - Matthys, Christophe

AU - Biesiekierski, Jessica

AU - Capiau, Luc

AU - Ceulemans, Steven

AU - Gernay, Olivier

AU - Jones, Lydia

AU - Maes, Sophie

AU - Peetermans, Christian

AU - Raat, Willem

AU - Stubbe, Jeroen

AU - Van Boxstael, Rudy

AU - Vandeput, Olivia

AU - Van Steenbergen, Sophie

AU - Van Oudenhove, Lukas

AU - Vanuytsel, Tim

AU - Jones, Michael

AU - Tack, Jan

AU - DOMINO Study Collaborators

AU - Goorden, Alain

AU - Snijkers, Alegonda

AU - Leys, An

AU - Roelofs, Annemiek

AU - Schoolmeesters, Bart

AU - Vander Putten, Bart

AU - Van den Broek, Benjamin

AU - Baade-Joret, Birgitta

AU - Huberlant, Céline

AU - Van Humbeek, David

AU - Van den Brande, Dirk

AU - Wyseyr, Dirk

AU - Lemmens, Els

AU - Brits, Ethel

AU - Simons, Guido

AU - Baetens, Hans

AU - Van Overmeire, Hendrika

AU - Tack, Hilde

AU - Cupers, Ilse

AU - Talboom, Ive

AU - Docx, Jonas

AU - Deseins, Judith

AU - Biot, Julie

AU - Vancaillie, Julie

AU - Vandeloo, Kara

AU - Louwies, Karlijn

AU - De Ceulaer, Karolien

AU - Lemmens, Karolien

AU - Scheers, Katrien

AU - Verleure, Leen

AU - De Sutter, Lies

AU - Plancke, Lies

AU - Bruyninckx, Liesbet

AU - Vanzeir, Liesbeth

AU - Vandersmisse, Lieve

AU - Wyseur, Linde

AU - Vermeersch, Lode

AU - Pas, Lodewijk

AU - De Greef, Lore

AU - Van Braeckel, Luc

AU - De Groote, Lut

AU - Groot, Maria

AU - Busschots, Marianne

AU - Landenne, Marie-Hélène

AU - Monstrey, Marieke

AU - Haemels, Marie-Magdalena

AU - Snellings, Marleen

AU - Sisk, Maura

AU - Van de Vyver, Nathalie

AU - Sannen, Nikea

AU - Thoné, Philippe

AU - Narongsack, Phouthalack

AU - Vrins, Pierre

AU - Geusens, Pieterjan

AU - Sauwens, Rik

AU - Musch, Sigrid

AU - Nous, Sigrid

AU - Mazereel, Sofie

AU - Biot, Stéphanie

AU - Geeraert, Stijn

AU - Caeyers, Tine

AU - Vanbelle, Vincent

N1 - Copyright the Author(s) 2022. Version archived for private and non-commercial use with the permission of the author/s and according to publisher conditions. For further rights please contact the publisher.

PY - 2022/11

Y1 - 2022/11

N2 - 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.

AB - 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.

UR - http://www.scopus.com/inward/record.url?scp=85130804452&partnerID=8YFLogxK

U2 - 10.1136/gutjnl-2021-325821

DO - 10.1136/gutjnl-2021-325821

M3 - Article

C2 - 35483886

AN - SCOPUS:85130804452

SN - 0017-5749

VL - 71

SP - 2226

EP - 2232

JO - Gut

JF - Gut

IS - 11

ER -

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

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