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Efficacy of a Low FODMAP Diet in the Absence of Lactose Malabsorption in Moderate to Severe ROME IV IBS.

RecruitingPhase 3Ages 18 Years - 75 YearsAllUniversitair Ziekenhuis Brussel
NCT05120752 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

Irritable bowel syndrome (IBS) is a frequently encountered disorder. According to the Rome IV criteria, it is characterized by abdominal pain associated with a change in stool frequency or con-sistency, or with symptomatic improvement by defecation (Mearin 2016). Associated symptoms, such as bloating and flatulence, are frequently reported. The underlying pathophysiology remains obscure, although several pathways have been proposed. Low-grade immune activation, visceral hypersensitivity, alteration in gut microbiome have all been reported (Mearin 2016). As diet exerts an impact on all these pathophysiological mechanisms, the role of dietary intervention receives spe-cial attention, with special interest in the role played by so-called fermentable oligo-, di-, monosac-charides and polyols (FODMAPs). Multiple studies indicated the beneficial effects of the low FODMAP diet in at least part

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📋 Eligibility rules (as published)
Inclusion Criteria: * \- Patients aged 18 - 75 years; * Fulfilling the ROME IV criteria for IBS; * Moderate symptom severity as defined by a IBS-SSS \> 175; * Consumption of lactose containing products. Exclusion Criteria: * \- Clinical suspicion of an organic disorder different from LI or IBS (patients can be included when this disorder had been excluded); * Known lactose intolerance; * Known inflammatory bowel disorder; * Known major intestinal motility disorder; * Alcohol (defined as more than 14 U per week) or other substance abuse; * Active psychiatric disorder; * Known systemic or auto-immune disorder with implication for the GI system; * Prior abdominal surgery (with the exception of appendectomy); * Any prior diagnosis of cancer other than basocellular carcinoma; * Current chemotherapy; * History of gastro-enteritis in the past 8 weeks; * Intake of antibiotics, pre- or probiotics during the past 8 weeks; * Dietary supplements unless taken at a stable dose for more than 8 weeks; * Treatment with neuromodulators (one neuromodulator taken at a stable dose for more than 12 weeks is allowed); * Treatment with spasmolytic agents, opioids, loperamide, gelatin tannate or mucoprotectants during the past 8 weeks; * LFD or low FODMAP diet in the past.
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What it tests

  • FODMAP diet
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Where

1 site
UZ Brussel
Jette, Belgium
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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