The DOMINO Trial: Diet Or Medication in Irritable Bowel syNdrOme

NCT ID: NCT04270487

Last Updated: 2020-11-17

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 472 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-07-26
• Study Completion Date: 2020-07-06

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.

Detailed Description

A randomized controlled trial (Phase IV trial) to evaluate the short-term efficacy and long-term health economic impact of a dietary intervention compared to pharmacotherapy with a musculotropic spasmolytic (otilonium bromide) agent for 470 newly diagnosed or newly treated irritable bowel syndrome patients in primary care.

The primary objective of this trial is to study treatment efficacy (IBS-SSS responder rate) with diet versus medication after 8 weeks of therapy.

The secondary endpoint is to study the quality of life and health economic impact over six months after the start of the initial treatment with diet versus medication.

Finally, patient satisfaction during and after the different treatment modalities, HRU and WPAI-IBS score in subgroups according to IBS stool pattern subtype, faecal microbiota and serotonin synthesis genetic polymorphisms will also be investigated

Conditions

Irritable Bowel Syndrome

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

IBS diet

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.

Group Type: EXPERIMENTAL

IBS Diet

Intervention Type: OTHER

Patients will be randomized to a diet or a mediation treatment

Otilonium bromide

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

Group Type: ACTIVE_COMPARATOR

Otilonium Bromide

Intervention Type: DRUG

Patients will be randomized to a diet or a mediation treatment

Interventions

IBS Diet

Patients will be randomized to a diet or a mediation treatment

Intervention Type: OTHER

Otilonium Bromide

Patients will be randomized to a diet or a mediation treatment

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

• 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.

Exclusion Criteria

• 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)

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Universitaire Ziekenhuizen KU Leuven

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Jan Tack, MD

Role: PRINCIPAL_INVESTIGATOR

Universitaire Ziekenhuizen KU Leuven

Locations

Univeristy Hospital Leuven

Leuven, Vlaams-Brabant, Belgium

Countries

Belgium

References

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.

Reference Type: DERIVED

PMID: 39086991 (View on PubMed)

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.

Reference Type: DERIVED

PMID: 35483886 (View on PubMed)

Other Identifiers

S59482

Identifier Type: -

Identifier Source: org_study_id