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Tests treatment safety and results for Irritable Bowel Syndrome
Official title Efficacy of a Low FODMAP Diet in the Absence of Lactose Malabsorption in Moderate to Severe ROME IV IBS.
ClinicalTrials.gov ID: NCT05120752
What this study is testing
- What it's testing
- 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).
- Phase 3: a large, late-stage study
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 75
You may be able to join if
- \- 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.
You likely can't join if
- \- 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;
See the full eligibility 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.
- \- 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.
The study team makes the final eligibility decision.
Where it's taking place
- Jette, Brussels Capital, Belgium
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 75 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Jette, Brussels Capital, Belgium. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.