Irritable Bowel Syndrome Trial, Recruiting NCT05097872 Sponsor: Universitaire Ziekenhuizen KU Leuven Condition: Irritable Bowel Syndrome
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Irritable Bowel Syndrome Trial, Recruiting

NCT05097872
Recruiting Not Applicable

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 70 years old (including age 70)
  • You are male or female
  • You have been diagnosed with IBS with diarrhea (IBS-D) or IBS with mixed bowel habits (IBS-M), based on specific diagnostic guidelines called Rome IV criteria
  • Your IBS symptoms are moderate to severe, based on a standard symptom scoring system (IBS-SSS score above 175 points)
  • You are willing and able to give written consent to take part in the study
  • If you are a woman who could become pregnant, you agree to use a highly effective form of birth control for the whole duration of the trial (such as implants, injections, combined contraceptive pills, certain coils/IUDs, complete abstinence, or a vasectomized partner); women who cannot become pregnant due to surgery or being postmenopausal for at least 2 years may also be eligible
  • You are able to understand the study, complete the questionnaires, and follow the study requirements

Who may not be able to join:

  • You are currently pregnant or breastfeeding
  • You have had major surgery on your digestive tract in the past (though gallbladder removal or a straightforward appendix removal are generally allowed)
  • Your main symptoms are linked to indigestion (functional dyspepsia) or acid reflux rather than IBS
  • You have a confirmed food allergy involving the immune system (IgE-mediated), identified by a blood test or skin prick test
  • You have a known underlying disease affecting your digestive system (as opposed to a functional condition like IBS)
  • You are currently using or have recently used certain medications, including anti-inflammatory painkillers (NSAIDs), stomach acid reducers (proton-pump inhibitors), certain antihistamines, mast cell stabilizers, steroids, or opioid-based painkillers — these would need to have been stopped at least 2 weeks before joining; or you have used antibiotics in the past 6 weeks
  • You have a known allergy to Fluorescein, Xylocaine (lidocaine), or Propofol (medications used during certain procedures)
  • You have been diagnosed with coeliac disease
  • You are currently following a specific diet that the trial team believes would interfere with the study's diet requirements (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
This study is not part of the standard drug-approval phase pathway (for example an observational, device, behavioural, or registry study), so a phase success rate does not apply.

Contact this trial

Phone: +32 16 37 70 90

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
Not Applicable
Registry
ClinicalTrials.gov
Start date
19 October 2021
Est. completion
1 October 2025

Where this trial is recruiting

🇧🇪 Belgium

Primary endpoints

Responder rates in targeted diet vs sham diet

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