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DOMINO TRIAL POST – HOC ANALYSIS: EVALUATION OF THE DIET EFFECTS ON SYMPTOMS IN IBS SUBTYPES

Claudia Di Rosa 1, Florencia Carbone 2, Karen Van den Houte 2, Annamaria Altomare 1, Michele Pier Luca Guarino 1, Jan Tack 2

Affiliations

1 Campus Bio Medico University, Rome, Italy

2 Leuven University Hospital, Leuven, Belgium

Summary

AI Generated

Post hoc analysis of the DOMINO trial showed that smartphone app-based FODMAP-lowering diet improved IBS symptom severity across all subtypes in 222 primary care patients over 24 weeks.

After 8 weeks, IBS symptom severity scores improved significantly in all subtypes (p<0.0001) and remained improved at 24 weeks, with overall responder rates of 72% at 8 weeks and 70% at 24 weeks.
Responder rates at 8 weeks varied by subtype: IBS-C 79%, IBS-U 74%, IBS-D 70%, and IBS-M 67%.
Quality of life improved in IBS-D and IBS-M subtypes after 8 weeks, and by 24 weeks improvement was observed across all subtypes.
Somatisation scores improved only in IBS-D patients at 8 weeks (p<0.05) and this improvement was maintained to 24 weeks (p<0.0001); depression and anxiety scores also improved in IBS-D by 24 weeks.
The authors conclude that the app-based FODMAP dietary intervention should be considered first-line treatment for IBS in primary care.

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This summary was generated by an AI large language model based on the content transcript. It is for informational purposes only and should not be considered a substitute for clinical judgment. Always rely on your professional expertise and the full clinical context when making clinical decisions.

Abstract

Introduction

IBS is a functional disorder of the gut-brain axis characterized by recurrent abdominal pain related to defecation and/or to a change in bowel habits [1]. According to stool type, 4 IBS-subtypes can be recognized: constipation prevalent (IBS-C), diarrhea prevalent (IBS-D), mixed (IBS-M) and unspecified (IBS-U) [2]. As a majority of IBS patients report symptom exacerbation by food, it is important to find a nutritional approach that could effectively reduce symptoms [3]. The present work is a post hoc analysis of the previously published DOMINO trial [4] conducted in Belgium in primary care. It showed that a FODMAP - lowering diet provided by a smartphone application was more effective than otilonium bromide after an 8-week treatment.

Aims & Methods

For this post hoc analysis, the diet arm population was stratified according to IBS subtype, with the aim of reporting a detailed evaluation of symptoms and psychosocial aspects with this new dietary intervention. 222 primary care IBS patients (85 IBS–M, 62 IBS–D, 44 IBS-C, and 31 IBS–U) followed a FODMAP-lowering diet for 8 weeks with the support of a smartphone application. Two follow up visits were scheduled after 16 and 24 weeks. IBS-Symptoms Severity Score (IBS-SSS), somatisation (PHQ 15), depression (PHQ 9), anxiety (GAD 7) and Quality of Life (QoL) status were evaluated. A One-way ANOVA with Dunnett’s post hoc test was conducted to assess differences between each time and the baseline. Significance was assessed with a p<0.05.

Results

After 8 weeks, IBS-SSS improved in all IBS-subtypes (p<0.0001) and this result was maintained until week 24 (p<0.0001). At week 8 the responder rate was 72% and it remained high (70%) until the end of the study. Evaluating each single subtype at week 8, IBS-C showed a responder rate of 79%, followed by IBS-U (74%), IBS-D (70%) and IBS-M (67%). After 8 weeks, PHQ-15 improved only in the IBS-D subgroup (p<0.05) and this result was maintained until week 24 (p<0.0001). PHQ-9 and GAD-7 did not show any significant differences after 8 weeks but they both significantly improved at the end of the follow up period (p<0.05) in the IBS-D subtype. QoL improved both in the IBS-D and IBS-M (p<0.05) subtypes after 8 weeks while at the end of the follow up the improvement was observed in all subtypes (p<0.05 in IBS-C, IBS–D and IBS-U and p<0.0001 in IBS-M) (Table 1)

Table 1 Symptoms Scores in the whole population; legend: a) p<0.05; b) p<0.0001
	IBS-SSS			PHQ-15			PHQ-9			GAD-7			QoL
	V0	8 weeks	24 weeks	V0	8 weeks	24 weeks	V0	8 weeks	24 weeks	V0	8 weeks	24 weeks	V0	8 weeks	24 weeks
IBS-C	295.9 ± 94.1	184.0 ± 112.5^b	184.0 ± 97.6^b	13.2 ± 5.3	10.7 ± 5.7	10.8 ± 4.05	7.7 ± 5.9	6.2 ± 5.4	5.0 ± 3.9	7.3 ± 5.2	5.7 ± 4.6	4.7 ± 3.6	79.6 ± 27.4	70.4 ± 27.1	63.4 ± 19.0^a
IBS-D	264.8 ± 89.2	161.6 ± 93.8^b	147.9 ± 112.7^b	13.1 ± 4.6	9.9 ± 5.0^a	8.6 ± 4.3^b	6.6 ± 4.5	4.9 ± 3.7	4.3 ± 3.3^a	7.0 ± 5.1	5.2 ± 4.3	4.4 ± 3.8^a	75.6 ± 20.6	65.2 ± 19.6^a	58.6 ± 15.1^a
IBS-M	269.2 ± 102.7	184.5 ± 123.4^b	170.9 ± 116.0^b	13.0 ± 5.7	10.9 ± 5.7	10.6 ± 5.9	6.8 ± 4.7	5.8 ± 5.1	5.8 ± 5.4	6.6 ± 4.7	5.9 ± 4.9	5.2 ± 4.7	78.9 ± 22.5	67.3 ± 24.3^a	62.1± 19.0^b
IBS-U	224.8 ± 79.8	128.1 ± 82.0^b	119.2 ± 74.9^b	11.1 ± 5.2	9.2 ± 4.1	9.4 ± 6.1	7.3 ± 5.4	5.0 ± 4.1	4.7 ± 4.9	6.6 ± 4.5	5.0 ± 4.2	5.7 ± 4.7	68.1 ± 18.0	59.0 ± 18.4	54.4 ± 19.6^a

Conclusion

Symptom severity improves significantly in all IBS subtypes when using a smartphone app-based FODMAP lowering diet intervention, and improved QoL especially in IBS-D and IBS-M subtypes. The DOMINO app-based dietary intervention should be considered the first-line treatment choice for primary care in IBS.

References

Sperber A.D., Bangdiwala S.I., Drossman D.A., Ghoshal U.C., Simren M., Tack J., Whitehead W.E., Dumitrascu D.L., Fang X., Fukudo S et al. Worldwide Prevalence and Burden of Functional Gastrointestinal Disorders, Results of Rome Foundation Global Study. Gastroenterology, 2021; 160:99-114.
Lacy BE, Mearin F, Chang L, Chey WD, Lembo AJ, Simren M, et al. Bowel Disorders. Gastroenterology. 2016;150(6):1393-1407.e1395.
Melchior C., Algera J., Colomier E., Tornblom H., Simren M. Irritable bowel syndrome with food-related symptoms: Future directions in the clinical management. United European Gastroenterol J. 2022 Jul;10(6):594-600.
Carbone F., Van den Houte K., Besard L., Tack C., Arts J., Caenepeel P., Piessevaux H., Vandenberghe A., Matthys C., Biesiekierski J. et al. Diet or medication in primary care patients with IBS: the DOMINO study – a randomised trial supported by the Belgian Health Care Knowledge Centre (KCE Trias Programme) and the Rome Foundation Research Institute. Gut, 2022; 0:1-7

Conference

UEG Week Copenhagen 2023

Topics

Colorectal

Submission format

Abstract

Session

PP 06 Other lower GI disorders (Posters)

Citation

United European Gastroenterology Journal 2023; 11 (Supplement 8)

Published

2023

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	Targeted group	General population
Gender, male	97%	33%
Median age, years	31	32
Smoking status Current/previous Non-smoker	41% (24) 59% (34)	34% (137) 66% (266)
Socioeconomic status(self-rated) Higher Middle Lower Prefer not to answer	69% (40/58) 22% (13/58) 0 9% (5/58)	85% (337/397) 11% (42/397) 0% (2/397) 4% (16/397)
Family history of H.pylori infection	3% (2)	9% (36)

Characteristics	Total (n=383)	Low-risk (n=102)	High-risk (n=281)	P value	High-risk (n=281)		P value
Characteristics	Total (n=383)	Low-risk (n=102)	High-risk (n=281)	P value	Follow-up (n=74)	Surgery (n=207)	P value
Followed-up period, mean± SD, months	65.6±15.3	64.3±14.6	66.1±15.5	0.328	63.8±21.8	66.9±12.5	0.139
Mortality, n (%)	46 (12.0)	11 (10.8)	35 (12.5)	0.657	21 (28.4)	14 (6.8)	<0.001
Mortality associated with T1 CRC, n (%)	5 (1.3)	0 (0)	5 (1.8)	0.175	2 (2.7)	3 (1.5)	0.484
Recurrence, n (%)	10 (2.6)	0 (0)	10 (3.6)	0.012	6 (8.1)	4 (1.9)	0.014
Local recurrence	5 (1.3)	0 (0)	5 (1.8)	0.175	5 (6.8)	0 (0)	<0.001
Distant recurrence	6 (1.6)	0 (0)	6 (2.1)	0.137	2 (2.7)	4 (1.9)	0.694
5-year OS, %	91.1	91.2	91.1	0.854	79.7	95.2	<0.001
5-year DSS, %	98.9	100	98.5	0.177	98.4	98.5	0.42

Primary outcome of interest— Detection of adenoma	ADR	Adjusted HR (95% CI)	P values
Main analysis (time-dependent analysis)* SGLT2-I users GLP-1 RA users	49.3% (5818/11812) 38.3% (374/977)	Ref 0.40(0.36-0.45)	<0.01
Secondary analysis (PSM analysis) SGLT2-I users GLP-1 RA users	46.7% (912/1954) 38.3% (374/977)	Ref 0.38(0.33-0.43)	<0.01

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