Irritable Bowel Syndrome Trial, Recruiting NCT06940596 Sponsor: University of Melbourne Condition: Irritable Bowel Syndrome
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Irritable Bowel Syndrome Trial, Recruiting

NCT06940596
Recruiting Not Applicable 🇦🇺 Australian site

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 currently live in Australia or the United States
  • You are 18 years of age or older
  • Your Body Mass Index (BMI) falls between 18.5 and 34.9 (confirm with trial site if unsure of your BMI)
  • You have been diagnosed with Irritable Bowel Syndrome (IBS) by a doctor or specialist dietitian
  • You currently meet a standard set of medical guidelines for IBS diagnosis called the "Rome IV criteria" (confirm with trial site)
  • Your IBS symptoms are currently active and above a certain level of severity (confirm with trial site)
  • You have access to a computer and the internet
  • You have enough English language and computer skills to complete an online text-based program
  • You are willing to make changes to your diet or daily habits as part of the treatment program
  • You are able to give your informed consent to participate

Who may not be able to join:

  • You have, or have previously had, another gut or digestive condition such as coeliac disease, Inflammatory Bowel Disease, or gastrointestinal cancer
  • You have had major surgery on your digestive system (not including appendix, gallbladder, or hemorrhoid removal)
  • You have certain warning symptoms — such as blood in your stool, recent unexplained weight loss of more than 5% of your body weight, a change in bowel habits if you are over 50, a family history of gut cancer or gut disease, large amounts of diarrhoea at night, fever with gut symptoms, repeated vomiting, or persistent unexplained iron deficiency — unless a doctor has already investigated these and provided written approval for you to join
  • You have a serious illness (such as severe diabetes, heart, liver, or neurological disease) that could explain your gut symptoms
  • You have a current or past diagnosis of a psychotic disorder or bipolar disorder
  • You currently have a substance abuse disorder, major depressive disorder, or active thoughts of suicide
  • You have a current or past diagnosis of an eating disorder
  • You are currently being fed through a tube or using nutritional supplement drinks (such as Ensure)
  • You are pregnant, breastfeeding, or planning to become pregnant during the 12-week study period
  • You have started taking, or changed the dose of, antibiotics or medications that affect your gut (such as anti-diarrhoeals or laxatives) in the past 3 months
  • You have started taking, or changed the dose of, probiotics, prebiotics, fibre supplements, or digestive enzymes in the past 3 months
  • You have started taking, or changed the dose of, any mental health medications in the past 3 months
  • You are currently receiving, or have previously received, behavioural therapy for IBS (such as Cognitive Behavioural Therapy/CBT) from a clinician
  • You are currently following, or have previously followed, a restrictive diet for IBS prescribed by a dietitian (such as the 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 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

Principal Investigator: Associate Professor Jessica Biesiekierski, University of Melbourne

Phone: +61 499 272 673

Australian sites

University of Melbourne, Melbourne, Victoria

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
University of Melbourne
Registry
ClinicalTrials.gov
Start date
22 May 2025
Est. completion
1 October 2027

Where this trial is recruiting

🇦🇺 Australia

1 site(s) in Australia. Confirm current status and contact details directly with the trial site.

Primary endpoints

Gastrointestinal Symptom Rating Scale-Irritable Bowel Syndrome (GSRS-IBS )

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