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Efficacy of the DOMINO Diet App in IBS (EDDI)

Primary Purpose

Irritable Bowel Syndrome

Status
Recruiting
Phase
Not Applicable
Locations
Belgium
Study Type
Interventional
Intervention
Dietary intervention: DOMINO app
Dietary intervention: low FODMAP diet
Sponsored by
Universitaire Ziekenhuizen KU Leuven
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Irritable Bowel Syndrome focused on measuring DOMINO, Low FODMAP diet, Irritable bowel syndrome

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • UZ LeuvenRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Other

Active Comparator

Arm Label

DOMINO app - DOMINO app

DOMINO app - low FODMAP diet

Arm Description

The patients start with the DOMINO diet (8 weeks). Patients that experienced symptom improvement, will continue with the DOMINO diet (6 weeks).

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).

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Full Information

First Posted
March 15, 2023
Last Updated
April 7, 2023
Sponsor
Universitaire Ziekenhuizen KU Leuven
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1. Study Identification

Unique Protocol Identification Number
NCT05808036
Brief Title
Efficacy of the DOMINO Diet App in IBS
Acronym
EDDI
Official Title
The Efficacy of the DOMINO Diet Application Versus the Low FODMAP Diet in Tertiary Care IBS Patients
Study Type
Interventional

2. Study Status

Record Verification Date
March 2023
Overall Recruitment Status
Recruiting
Study Start Date
April 2023 (Anticipated)
Primary Completion Date
November 3, 2024 (Anticipated)
Study Completion Date
November 30, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Universitaire Ziekenhuizen KU Leuven

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Irritable Bowel Syndrome
Keywords
DOMINO, Low FODMAP diet, Irritable bowel syndrome

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
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)
Allocation
Non-Randomized
Enrollment
100 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
DOMINO app - DOMINO app
Arm Type
Other
Arm Description
The patients start with the DOMINO diet (8 weeks). Patients that experienced symptom improvement, will continue with the DOMINO diet (6 weeks).
Arm Title
DOMINO app - low FODMAP diet
Arm Type
Active Comparator
Arm Description
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).
Intervention Type
Other
Intervention Name(s)
Dietary intervention: DOMINO app
Intervention Description
Life style intervention and diet low in FODMAPs.
Intervention Type
Other
Intervention Name(s)
Dietary intervention: low FODMAP diet
Intervention Description
Strict low FODMAP diet.
Primary Outcome Measure Information:
Title
Symptom response DOMINO app and low FODMAP diet
Description
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 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Jan Tack
Phone
016344225
Email
jan.tack@kuleuven.be
First Name & Middle Initial & Last Name or Official Title & Degree
Karen Routhiaux
Phone
016372847
Email
karen.routhiaux@kuleuven.be
Facility Information:
Facility Name
UZ Leuven
City
Leuven
Country
Belgium
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jan Tack, Prof., MD

12. IPD Sharing Statement

Plan to Share IPD
No

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Efficacy of the DOMINO Diet App in IBS

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