Phase 3 Irritable Bowel Syndrome Trial, Recruiting NCT04974593 Sponsor: Universitair Ziekenhuis Brussel Condition: Irritable Bowel Syndrome
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Phase 3 Irritable Bowel Syndrome Trial, Recruiting

NCT04974593
Recruiting Phase 3

Who may be able to join

AI generated eligibility summary. Written by an AI model from the official source data and checked on a sample basis. It can contain mistakes, so confirm anything important against the original source. How we use AI

Who might be able to join this trial:

  • You have been diagnosed with Irritable Bowel Syndrome (IBS) according to a standard set of medical guidelines called the ROME IV criteria
  • Your IBS symptoms are at least moderate in severity, based on a specific symptom scoring system (confirm with trial site)
  • You regularly eat or drink products that contain lactose (such as milk, cheese, or yogurt)

Who may not be able to join:

  • You have signs of another gut or digestive condition that has not yet been ruled out by a doctor
  • You have already been diagnosed with lactose intolerance or difficulty absorbing lactose
  • You have a known inflammatory bowel disease (such as Crohn's disease or ulcerative colitis)
  • You have a known condition that affects how your gut moves food through your system
  • You drink more than 14 units of alcohol per week, or misuse other substances
  • You currently have an active mental health condition
  • You have a known immune system or whole-body condition that affects your digestive system
  • You have had abdominal surgery in the past (except for appendix removal)
  • You have ever been diagnosed with any type of cancer, other than a specific type of minor skin cancer (basocellular carcinoma)
  • You are currently receiving chemotherapy
  • You had a stomach bug or gut infection in the past 8 weeks
  • You have taken antibiotics, prebiotics, or probiotics in the past 8 weeks
  • You are taking dietary supplements that you have not been on at a steady dose for more than 8 weeks
  • You are taking certain nerve-affecting medications, unless you have been on a stable dose of just one such medication for more than 12 weeks
  • You have taken certain gut-related medications (such as antispasmodics, opioids, or loperamide) in the past 8 weeks
  • You have previously followed a low-lactose or low-FODMAP diet

Important: Always verify eligibility with the trial site directly before applying.

Based on publicly available eligibility criteria from ClinicalTrials.gov. Verify directly with the trial site before acting. This is not medical advice.

This is a simplified plain English summary of the eligibility criteria. Full criteria are set by the trial investigators and may include additional requirements not shown here. Never self-exclude from a trial based on this summary. Contact the trial site directly to confirm your eligibility.
Last synced 28 July 2026
Phase 3: approximately ~65% of drugs entering this phase reach regulatory approval, based on published industry-wide historical data. This is not specific to this trial.
Phase success rates shown are historical industry-wide averages based on published data. They are not a prediction for this specific trial or your individual situation.

Contact this trial

Phone: +32 2 476

Contact details sourced from ClinicalTrials.gov. Verify directly with the trial site before attending.

GP referral letter

Print a one-page summary to share with your doctor.

Trial details

Status
Recruiting
Phase
Phase 3
Sponsor
Universitair Ziekenhuis Brussel
Registry
ClinicalTrials.gov
Start date
22 October 2021
Est. completion
1 January 2028

Where this trial is recruiting

🇧🇪 Belgium

Primary endpoints

symptomatic improvement

Can't join this trial?

Expanded access pathways

If this trial is not available to you, other access pathways may exist. In Australia, the TGA Special Access Scheme allows access to unapproved therapeutic goods for individual patients.

TGA Special Access Scheme information

Find other recruiting trials on ClinicalTrials.gov

Data last synced from ClinicalTrials.gov: 28 July 2026. Trial status can change. Always verify current status directly with the trial site before making any decision.

Trial recruitment status can change without notice between our nightly data updates. Always contact the trial site directly to confirm current recruitment status before making any decisions or travel arrangements.

View original record on ClinicalTrials.gov