Phase 3 Irritable Bowel Syndrome Trial, Recruiting NCT05815602 Sponsor: Guy Boeckxstaens Condition: Irritable Bowel Syndrome
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Phase 3 Irritable Bowel Syndrome Trial, Recruiting

NCT05815602
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 willing to give written consent to take part before any screening begins
  • You have been diagnosed with Irritable Bowel Syndrome (IBS) that does not involve mainly constipation, based on standard medical criteria called Rome IV
  • Tests have ruled out other conditions that could explain your symptoms, such as coeliac disease (blood test), lactose intolerance (breath test), inflammatory bowel disease, and a gut infection called giardiasis (stool test)
  • If you have lactose intolerance, you may still be able to join if avoiding lactose for 6 weeks did not improve your symptoms
  • You are between 18 and 65 years old

Who may not be able to join:

  • You have a history of coeliac disease, food allergy, giardiasis, inflammatory bowel disease, stomach or gut infection, a gut movement disorder, serious liver, kidney, heart or lung disease, known heart rhythm problems, insulin-dependent diabetes, or a psychiatric illness
  • You are currently pregnant or breastfeeding
  • You are taking certain medications, including antidepressants, antipsychotics, antihistamines/allergy medicines, medicines that affect gut movement or sensitivity, most painkillers (only paracetamol is allowed), or certain other drugs that interact with how the body processes medicines — including some antibiotics, antifungals, heart medicines, and herbal products like St. John's Wort or grapefruit (confirm with trial site for the full list)
  • Your IBS symptoms began after abdominal surgery
  • Your IBS is mainly constipation-type (known as IBS-C)
  • You have a known allergy or sensitivity to the active ingredient or any component of the trial medication (confirm with trial site)

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: Guy Boeckxstaens, prof. dr., KU Leuven

Phone: +3216341943

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
Guy Boeckxstaens
Registry
ClinicalTrials.gov
Start date
30 March 2023
Est. completion
1 October 2027

Where this trial is recruiting

🇧🇪 Belgium

Primary endpoints

Clinical Response to Abdominal Pain Intensity; Clinical Response to Global Relief of Symptoms

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