Irritable Bowel Syndrome Trial, Recruiting NCT06104631 Sponsor: Biokuris s.a. Condition: Irritable Bowel Syndrome
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Irritable Bowel Syndrome Trial, Recruiting

NCT06104631
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 75 years old
  • You have been diagnosed with Crohn's disease and have been in remission (no active flare-up) for more than 3 months without using steroids
  • Your doctor considers your Crohn's disease to currently be in remission
  • Your blood or other tests show no signs of active inflammation at the start of the trial
  • You experience gut symptoms similar to irritable bowel syndrome (IBS), such as bloating or bowel changes, even though your Crohn's is in remission
  • You have rated your abdominal pain at a certain level of discomfort on a simple rating scale (confirm with trial site)
  • You have filled in study questionnaires accurately and completely during a warm-up period before joining (at least 75% completion required)
  • You are willing to keep taking all your current medications at the same doses throughout the study
  • You are taking certain medications like anti-spasmodics, probiotics, or antidepressants and have been on a stable dose for more than one month before joining
  • You agree to keep your normal daily habits and lifestyle the same during the study
  • You have read and signed the consent form agreeing to take part
  • You are able to communicate with the study team and complete questionnaires
  • You own a smartphone or tablet
  • You are willing to attend all study visits and follow the study instructions
  • If you could become pregnant, you agree to use an approved form of contraception throughout the study
  • You are able to read and write in French

Who may not be able to join:

  • You have other gut or digestive conditions alongside Crohn's disease, such as anal or perineal wounds, Crohn's-related conditions outside the gut, a history of colorectal cancer, abdominal radiotherapy, a narrowing of the intestine causing symptoms, or a history of substance dependence
  • You have serious other health conditions, such as unstable heart disease, poorly controlled diabetes, or an unstable thyroid condition
  • You have taken anti-inflammatory painkillers (like ibuprofen), steroids, opioids, or narcotic painkillers in the month before the study starts
  • You have recently started a new diet or a new treatment for gut symptoms (such as probiotics, antidepressants, or antispasmodics) within one month before joining
  • You are currently taking antibiotics or have taken them within the two weeks before joining
  • You drink more alcohol than the recommended limit for this study (more than 3 drinks per day for men, or more than 2 drinks per day for women), or you use recreational drugs
  • You are pregnant, breastfeeding, or planning to become pregnant during the study
  • You have taken part in another clinical trial within the last 3 months, or are currently in one
  • You have a known allergy or sensitivity to any ingredient in the study product
  • You are under a legal guardianship order or have had your personal freedoms restricted by a legal or administrative decision

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
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 4 259 85 00

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
Sponsor
Biokuris s.a.
Registry
ClinicalTrials.gov
Start date
12 March 2024
Est. completion
1 August 2025

Where this trial is recruiting

🇧🇪 Belgium 🇫🇷 France

Primary endpoints

Subject's global assessment (SGA)

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