NCT05120752 Efficacy of a Low FODMAP Diet in the Absence of Lactose Malabsorption in Moderate to Severe ROME IV IBS.
| NCT ID | NCT05120752 |
| Status | Recruiting |
| Phase | Phase 3 |
| Sponsor | Universitair Ziekenhuis Brussel |
| Condition | Irritable Bowel Syndrome |
| Study Type | INTERVENTIONAL |
| Enrollment | 60 participants |
| Start Date | 2021-11-02 |
| Primary Completion | 2028-01 |
Eligibility & Interventions
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 3 trials are large pivotal studies comparing the treatment to current standard of care or placebo. Your participation directly contributes to the evidence needed for regulatory approval.
This trial targets 60 participants in total. It began in 2021-11-02 with a primary completion date of 2028-01.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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 of the patients (Halmos 2014, Eswaran 2016, Staudacher 2017). As a disaccharide, lactose is part of the FODMAPs. Lactose intolerance (LI) results from lactose malabsorption (LM) secondary to insufficient hydrolysis of the disaccharide lactose into galactose and glucose (Misselwitz 2019). The undigested lactose will eventually reach the colon, resulting in fermentation from colonic bacteria with production of different compounds such as short chain fat-ty acids, carbon dioxide, H2 and methane (Catanzaro 2021). These compounds have an osmotic effect and can stimulate colonic contractions. In patients suffering from LI, these pathophysiologi-cal mechanisms generate symptoms such as abdominal pain and cramps, flatulence, diarrhea, in-creased bowel sounds, among others, similar to the mechanisms by which FODMAPs induce symp-toms of IBS. As dairy products are highly present in our Western diet, LI will often be considered in patients presenting with such symptoms and they will be referred for further testing. When LM is diagnosed, a lactose-free diet (LFD) will be advocated to alleviate symptoms. While the earlier-mentioned studies investigated symptomatic improvement by the low FODMAP diet, it remains uncertain whether this restrictive diet remains beneficial in patients without evidence of LM. In a recent study the low FODMAP diet and LFD provided comparable improvement in symptom severity (Krieger-Grübel 2020). This study aims to: * Assess the improvement in IBS symptoms and quality of life (QOL) by a low FODMAP di-et when lactose malabsorption has been previously excluded; * Compare the improvement in IBS symptoms and QOL obtained by a low FODMAP diet to a lactose free diet (data from the PreVaIL study).
Eligibility Criteria
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.
Contact & Investigator
Sébastien Kindt, MD
PRINCIPAL INVESTIGATOR
Universitair Ziekenhuis Brussel
Frequently Asked Questions
Who can join the NCT05120752 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 75 Years, studying Irritable Bowel Syndrome. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT05120752 trial and what does that mean for participants?
Phase 3 trials are large-scale studies comparing the new treatment to existing standards of care or a placebo. They provide the evidence needed for regulatory approval. This trial targets 60 participants.
Is NCT05120752 currently recruiting?
Yes, NCT05120752 is actively recruiting participants. Contact the research team at sebastien.kindt@uzbrussel.be for enrollment information.
Where is the NCT05120752 trial being conducted?
This trial is being conducted at Jette, Belgium.
Who is sponsoring the NCT05120752 clinical trial?
NCT05120752 is sponsored by Universitair Ziekenhuis Brussel. The principal investigator is Sébastien Kindt, MD at Universitair Ziekenhuis Brussel. The trial plans to enroll 60 participants.