Efficacy of the DOMINO Diet App in IBS
ConditionIrritable Bowel Syndrome
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-70
SponsorUniversitaire Ziekenhuizen KU Leuven
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
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
Trial design
Design model
Parallel
Treatments tested in this trial
Dietary intervention: DOMINO app
Other interventionLife style intervention and diet low in FODMAPs.
Dietary intervention: low FODMAP diet
Other interventionStrict low FODMAP diet.
Treatment groups
110 Participants
are divided into 2 treatment groupsGroup A: DOMINO app - DOMINO appOther 1 intervention
Group B: DOMINO app - low FODMAP dietActive comparator 2 interventions
Trial outcomes
Primary outcomes
1
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.
Time frame
18 monthsSponsors and contacts
Click on the lead sponsor to view all of their trials.
Source ClinicalTrials.gov