Phase 3 Irritable Bowel Syndrome Trial, Recruiting NCT05120752 Sponsor: Universitair Ziekenhuis Brussel Condition: Irritable Bowel Syndrome
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Phase 3 Irritable Bowel Syndrome Trial, Recruiting

NCT05120752
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 are between 18 and 75 years old
  • You have been diagnosed with Irritable Bowel Syndrome (IBS) based on a specific set of standard medical guidelines called the Rome IV criteria
  • Your IBS symptoms are at a moderate level of severity, based on a specific symptom scoring system (confirm with trial site)
  • You regularly eat or drink foods that contain lactose, such as milk, cheese, or yogurt

Who may not be able to join:

  • You are suspected of having a gut-related condition other than lactose intolerance or IBS, unless that condition has already been ruled out by tests
  • You have already been diagnosed with lactose intolerance
  • You have a known inflammatory bowel disease, such as Crohn's disease or ulcerative colitis
  • You have a known condition that seriously affects how your bowels move or function
  • You drink more than 14 units of alcohol per week, or misuse other substances
  • You currently have an active mental health (psychiatric) disorder
  • You have a known condition affecting your whole body or immune system that also affects your digestive system
  • You have had abdominal surgery in the past, except for an appendix removal
  • You have ever been diagnosed with any type of cancer, except for a common, low-risk type of skin cancer (basocellular carcinoma)
  • You are currently receiving chemotherapy
  • You had a stomach or gut infection in the past 8 weeks
  • You have taken antibiotics, prebiotics, or probiotics in the past 8 weeks
  • You take dietary supplements, unless you have been on the same dose for more than 8 weeks
  • You take nerve-related medications (neuromodulators), unless you have been on the same dose of just one such medication for more than 12 weeks
  • You have taken certain gut-related medications — such as antispasmodics, opioids, or specific gut-lining treatments — in the past 8 weeks (confirm with trial site for specific medications)
  • You have previously followed a low-fibre diet or a low FODMAP diet (a special diet that limits certain carbohydrates)

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 22 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

Principal Investigator: Sébastien Kindt, MD, Universitair Ziekenhuis Brussel

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
2 November 2021
Est. completion
1 January 2028

Where this trial is recruiting

🇧🇪 Belgium

Primary endpoints

symptomatic improvement; Evolution of Quality of life scale

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: 22 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