Skip to main page content
U.S. flag

An official website of the United States government

Dot gov

The .gov means it’s official.
Federal government websites often end in .gov or .mil. Before sharing sensitive information, make sure you’re on a federal government site.

Https

The site is secure.
The https:// ensures that you are connecting to the official website and that any information you provide is encrypted and transmitted securely.

Access keys NCBI Homepage MyNCBI Homepage Main Content Main Navigation
Randomized Controlled Trial
. 2022 Nov;71(11):2226-2232.
doi: 10.1136/gutjnl-2021-325821. Epub 2022 Apr 28.

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  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
Collaborators, Affiliations
Randomized Controlled Trial

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 et al. Gut. 2022 Nov.

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.

Keywords: IRRITABLE BOWEL SYNDROME; PRIMARY CARE; QUALITY OF LIFE.

PubMed Disclaimer

Conflict of interest statement

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.

Figures

Figure 1
Figure 1
Consolidated Standards of Reporting Trials (CONSORT) diagram.
Figure 2
Figure 2
Responder rate was significantly higher in the diet group compared with medication after 4 (p=0.02) and 8 weeks (p=0.03) and more pronounced in Rome+ patients (p=0.004) based on Pearson χ2 test. OB, otilonium bromide; t.i.d., three times a day.
Figure 3
Figure 3
Change (±SE) in IBS-SSS at start, after 4 (p=0.007) and 8 weeks (p=0.049) of treatment based on mixed-model analysis. IBS-SSS, IBS Symptom Severity Scale; OB, otilonium bromide; t.i.d., three times a day.
See this image and copyright information in PMC

Comment in

Similar articles

See all similar articles

Cited by

See all "Cited by" articles

References

    1. Drossman DA. Functional gastrointestinal disorders: what's new for Rome IV? Lancet Gastroenterol Hepatol 2016;1:6–8. 10.1016/S2468-1253(16)30022-X - DOI - PubMed
    1. Sperber AD, Bangdiwala SI, Drossman DA, et al. . Worldwide prevalence and burden of functional gastrointestinal disorders, results of Rome Foundation global study. Gastroenterology 2021;160:99–114. 10.1053/j.gastro.2020.04.014 - DOI - PubMed
    1. Van den Houte K, Carbone F, Pannemans J, et al. . Prevalence and impact of self-reported irritable bowel symptoms in the general population. United European Gastroenterol J 2019;7:307–15. 10.1177/2050640618821804 - DOI - PMC - PubMed
    1. Tack J, Stanghellini V, Mearin F, et al. . Economic burden of moderate to severe irritable bowel syndrome with constipation in six European countries. BMC Gastroenterol 2019;19:69. 10.1186/s12876-019-0985-1 - DOI - PMC - PubMed
    1. Canavan C, West J, Card T. Review article: the economic impact of the irritable bowel syndrome. Aliment Pharmacol Ther 2014;40:1023–34. 10.1111/apt.12938 - DOI - PubMed

Publication types

Associated data