Phase
Condition
Lactose Intolerance
Colic
Gastrointestinal Diseases And Disorders
Treatment
Dietary intervention: low FODMAP diet
Dietary intervention: DOMINO app
Clinical Study ID
Ages 18-70 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
Voluntary written informed consent of the participant or their legally authorizedrepresentative has been obtained prior to any screening procedures
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.
Patients with irritable bowel syndrome according to Rome IV diagnostic criteria
Patients ages between 18 and 70 years old
Exclusion
Exclusion Criteria:
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
Any disorder, which in the Investigator's opinion might jeopardise the participant'ssafety or compliance with the protocol
Any prior or concomitant treatment(s) that might jeopardise the participant's safetyor that would compromise the integrity of the Trial
Female who is pregnant, breast-feeding or intends to become pregnant or is ofchild-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 ofgastro-oesophageal reflux disease (GERD)
Patients following a diet interfering with the study diet in opinion of theinvestigator
Patients who already followed the low FODMAP diet under guidance of a traineddietitian without success
Study Design
Connect with a study center
UZ Leuven
Leuven,
BelgiumActive - Recruiting
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