The DOMINO Trial: Diet Or Medication in Irritable Bowel syNdrOme

NCT04270487 | Completed Phase 4

• 1 other identifier: S59482
• Study Type: interventional
• Target: 472
• Locations: 1 country
• Sites: 1

Brief Summary

A randomized controlled trial to evaluate the short-term efficacy and long-term health economic impact of a dietary intervention compared to pharmacotherapy with a musculotropic spasmolytic agent for newly diagnosed or newly treated irritable bowel syndrome in primary care.

Conditions

Irritable Bowel Syndrome

Outcome Measures

Primary Outcomes (1)

• Treatment efficacy of symptom severity

  IBS-SSS: IBS symptom severity score The maximum achievable score is 500. Mild, moderate and severe cases were indicated by scores of 75 to 175, 175 to 300 and \>300 respectively. Controls scored below 75 and patients scoring in this range can be considered to be in remission. Efficacy of treatment will be assess by calculating the proportion of patients in each arm with a drop of 50 points or more on the IBS-SSS. The higher the drop, the more the patient has improved.

  1.5 year

Secondary Outcomes (1)

• Treatment efficacy in quality of life

  1.5 year

Other Outcomes (8)

• Quality of life in IBS

  1.5 year

• Work Productivity and Activity Impairment in IBS

  1.5 year

• Depression levels in IBS

  1.5 year

Study Arms (2)

IBS diet

EXPERIMENTAL

The simple IBS diet is a diet based on the Low FODMAPs diet and the NICE (National Institute of Health and Care Excellence) IBS diet. Patients will be aid to follow the diet with a mobile app.

Other: IBS Diet

Otilonium bromide

ACTIVE COMPARATOR

Otilonium bromide is a a frequently used musculotropic spasmolytic. The dosis used will be 40 mg t.i.d.

Drug: Otilonium Bromide

Interventions

IBS Diet OTHER

Patients will be randomized to a diet or a mediation treatment

IBS diet

Otilonium Bromide DRUG

Patients will be randomized to a diet or a mediation treatment

Otilonium bromide

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Eligible patients are those of either gender, above the age of 18, eligible to give informed consent.
• Newly diagnosed with or newly to be treated for IBS in primary care, as this is the setting where the majority of these patients is managed. The diagnostic gold standard, in line with clinical practice, will be clinician's diagnostic judgment.
• Supportive information for the diagnosis of IBS will be provided to the GPs at the initial investigators meeting. This includes: a guidance for diagnosis and potentially useful additional tests based on the Rome IV management algorithm, a Rome IV-based diagnostic questionnaire with pictograms and a list of alarm symptoms.
• Patients who did not receive treatment over the preceding 3 months, and who did not receive long-term treatment (\>3 consecutive weeks) with otilonium bromide in the past are eligible for the trial.

You may not qualify if:

• Patients not capable to understand or be compliant with the study.
• Patients with concurrent organic gastrointestinal disease (inflammatory bowel disease), a history of major bowel surgery (not including minimal invasive surgery such as appendectomy or cholecystectomy, but including sigmoidectomy, hemicolectomy and small bowel resections)
• Patients who received treatment with otilonium bromide in the past for more than 3 weeks consecutively or who received otilonium bromide recently for any duration in the last 3 months.
• Patients who have used FODMAP or NICE diet before.
• Patients who recently (last 3 weeks) used other medication for IBS, or who changed their diet for IBS or for any other reason over the last 3 months. To be included in the trial patients should stop these treatments following the advice of their GP (see paragraph 8.9).
• Patients with diabetes, uncontrolled thyroid disease, active malignant disease (not including patients with cancer free diagnosis for more than 5 years), symptomatic uncontrolled endometriosis.
• Patients with a major psychiatric disease. The use of a single antidepressant on a stable dose for at least 3 months is allowed (see paragraph 8.9).
• Patients with drug abuse and/or alcohol abuse.
• Patients on pharmacologically prepared probiotic formulations (i.e. bought in the pharmacy) will be excluded. The use of probiotic drinks or yoghurts available from food stores, such as Activia®, Yakult ®, Actimel ®, is allowed but should be registered as "complementary treatment"(see paragraph 8.9).
• Women with active pregnancy plans in the coming 6 months are not eligible and women of childbearing potential are only eligible if they use effective contraception throughout the study. Also excluded are women of childbearing potential not using effective contraception or women planning to become pregnant the next 6 months (see paragraph 8.9). Methods of contraception considered highly effective are: combined (oestrogen and progestogen containing) hormonal contraception associated with inhibition of ovulation (oral, intravaginal, transdermal), progestogen-only hormonal contraception associated with inhibition of ovulation (oral, injectable, implantable), intrauterine device (IUD), intrauterine hormone-releasing system (IUS), bilateral tubal occlusion, a vasectomized partner or sexual abstinence (http://www.hma.eu/fileadmin/dateien/Human\_Medicines/01-About\_HMA/Working\_Groups/CTFG/2014\_09\_HMA\_CTFG\_Contraception.pdf)

Sponsors & Collaborators

• Universitaire Ziekenhuizen KU Leuven: lead

Study Sites (1)

Univeristy Hospital Leuven

Leuven, Vlaams-Brabant, 3000, Belgium

Location

Related Publications (3)

• Tack C, Van den Houte K, Besard L, Capiau L, Ceulemans S, Gernay O, Maes S, Peetermans C, Raat W, Stubbe J, Van Boxstael R, Vandeput O, Van Steenbergen S, Gehesquiere B, Raes J, Tack J, Carbone F. A study on the utility of inflammatory biomarkers in primary care irritable bowel syndrome: a sub analysis of the DOMINO randomized trial. BMC Gastroenterol. 2025 Dec 23. doi: 10.1186/s12876-025-04494-7. Online ahead of print.

  PMID: 41436948 DERIVED

• Di Rosa C, Van den Houte K, Altomare A, Guarino MPL, Besard L, Arts J, Caenepeel P, Piessevaux H, Vandenberghe A, Matthys C, Biesiekierski JR, 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, Carbone F. DOMINO trial post hoc analysis: evaluation of the diet effects on symptoms in IBS subtypes. Therap Adv Gastroenterol. 2024 Jul 30;17:17562848241255296. doi: 10.1177/17562848241255296. eCollection 2024.

  PMID: 39086991 DERIVED

• 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; Domino Study Collaborators. 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.

  PMID: 35483886 DERIVED

MeSH Terms

Conditions

Irritable Bowel Syndrome

Interventions

octylonium

Condition Hierarchy (Ancestors)

Colonic Diseases, Functional; Colonic Diseases; Intestinal Diseases; Gastrointestinal Diseases; Digestive System Diseases

Study Officials

• Jan Tack, MD

  Universitaire Ziekenhuizen KU Leuven

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Randomized Parallel study: diet vs medication (otilonium bromide)

Study Record Dates

• First Submitted: September 27, 2019
• First Posted: February 17, 2020
• Study Start: July 26, 2018
• Primary Completion: May 4, 2020
• Study Completion: July 6, 2020
• Last Updated: November 17, 2020

Record last verified: 2020-11

Locations

BE (1)