Efficacy of the DOMINO Diet App in IBS

Last updated: June 28, 2024
Sponsor: Universitaire Ziekenhuizen KU Leuven
Overall Status: Active - Recruiting

Phase

N/A

Condition

Lactose Intolerance

Colic

Gastrointestinal Diseases And Disorders

Treatment

Dietary intervention: low FODMAP diet

Dietary intervention: DOMINO app

Clinical Study ID

NCT05808036
S67508
  • Ages 18-70
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  1. Voluntary written informed consent of the participant or their legally authorizedrepresentative has been obtained prior to any screening procedures

  2. Use of highly effective methods of birth control; defined as those that, alone or incombination, result in low failure rate (i.e., less than 1% per year) when usedconsistently and correctly; such as implants, injectables, combined oralcontraceptives, some IUDs, true sexual abstinence (i.e. refraining from heterosexualintercourse during the entire period of risk associated with the Trial treatment(s))or commitment to a vasectomised partner.

  3. Patients with irritable bowel syndrome according to Rome IV diagnostic criteria

  4. Patients ages between 18 and 70 years old

Exclusion

Exclusion Criteria:

  1. Participant has a history of any major psychiatric disorders (including those with amajor psychosomatic element to their gastrointestinal disease), depression, alcoholor substance abuse in the last 2 years

  2. Any disorder, which in the Investigator's opinion might jeopardise the participant'ssafety or compliance with the protocol

  3. Any prior or concomitant treatment(s) that might jeopardise the participant's safetyor that would compromise the integrity of the Trial

  4. Female who is pregnant, breast-feeding or intends to become pregnant or is ofchild-bearing potential and not using an adequate, highly effective contraceptive

  5. Participation in an interventional Trial with an investigational medicinal product (IMP) or device

  6. Patients presenting with predominant symptoms of functional dyspepsia (FD) and ofgastro-oesophageal reflux disease (GERD)

  7. Patients following a diet interfering with the study diet in opinion of theinvestigator

  8. Patients who already followed the low FODMAP diet under guidance of a traineddietitian without success

Study Design

Total Participants: 100
Treatment Group(s): 2
Primary Treatment: Dietary intervention: low FODMAP diet
Phase:
Study Start date:
April 01, 2023
Estimated Completion Date:
November 30, 2024

Connect with a study center

  • UZ Leuven

    Leuven,
    Belgium

    Active - Recruiting

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