Efficacy of the DOMINO Diet App in IBS

Study Overview
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Brief Summary
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The aim of this study is to evaluate whether the DOMINO diet application is an effective tool in the treatment of Irritable bowel syndrome in tertiary care. Furthermore, this study aims to determine the response rate of the strict low FODMAP diet in non-responders to the DOMINO diet.

Official Title
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The Efficacy of the DOMINO Diet Application Versus the Low FODMAP Diet in Tertiary Care IBS Patients

Conditions
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Irritable Bowel Syndrome

Intervention / Treatment
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* Other: Dietary intervention: DOMINO app
* Other: Dietary intervention: low FODMAP diet


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Voluntary written informed consent of the participant or their legally authorized representative has been obtained prior to any screening procedures Use of highly effective methods of birth control; defined as those that, alone or in combination, result in low failure rate (i.e., less than 1% per year) when used consistently and correctly; such as implants, injectables, combined oral contraceptives, some IUDs, true sexual abstinence (i.e. refraining from heterosexual intercourse during the entire period of risk associated with the Trial treatment(s)) or commitment to a vasectomised partner. Patients with irritable bowel syndrome according to Rome IV diagnostic criteria Patients ages between 18 and 70 years old Exclusion Criteria: Participant has a history of any major psychiatric disorders (including those with a major psychosomatic element to their gastrointestinal disease), depression, alcohol or substance abuse in the last 2 years Any disorder, which in the Investigator's opinion might jeopardise the participant's safety or compliance with the protocol Any prior or concomitant treatment(s) that might jeopardise the participant's safety or that would compromise the integrity of the Trial Female who is pregnant, breast-feeding or intends to become pregnant or is of child-bearing potential and not using an adequate, highly effective contraceptive Participation in an interventional Trial with an investigational medicinal product (IMP) or device Patients presenting with predominant symptoms of functional dyspepsia (FD) and of gastro-oesophageal reflux disease (GERD) Patients following a diet interfering with the study diet in opinion of the investigator Patients who already followed the low FODMAP diet under guidance of a trained dietitian without success

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: All patients will start with the DOMINO diet. Depending on the symptom improvement they will continue the DOMINO diet or switch to the strict low FODMAP diet.
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: DOMINO app - DOMINO app<br>The patients start with the DOMINO diet (8 weeks). Patients that experienced symptom improvement, will continue with the DOMINO diet (6 weeks). | Other: Dietary intervention: DOMINO app<br>* Life style intervention and diet low in FODMAPs.<br>|
| Active Comparator: DOMINO app - low FODMAP diet<br>The patients start with the DOMINO diet (8 weeks). Patients that experienced no symptom improvement, will switch to the strict low FODMAP diet (6 weeks). | Other: Dietary intervention: DOMINO app<br>* Life style intervention and diet low in FODMAPs.<br>Other: Dietary intervention: low FODMAP diet<br>* Strict low FODMAP diet.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Symptom response DOMINO app and low FODMAP diet | The symptom response is measured by the Irritable Bowel Syndrome Symptom Severity Scale (IBS-SSS). In this questionnaire, each question (5) is scored from 0-100, with a maximum total score of 500. Improvement is defined as a 50-point or more drop on the IBS-SSS. The score is positively correlated with severity of IBS symptoms, a score from 50-175 indicated mild disease, 175-300 moderate and >300 severe. | 18 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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DOMINO, Low FODMAP diet, Irritable bowel syndrome