Diet or therapy? new study aims to find the best online treatment for IBS
NCT ID NCT06940596
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This study compares two online treatments for Irritable Bowel Syndrome (IBS): a low-FODMAP diet program and exposure-based cognitive behavioral therapy (E-CBT). Researchers want to find out which treatment works best for different people and how they work. The study will include 235 adults in Australia and the US who have been diagnosed with IBS and are currently experiencing symptoms.
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Study facts
What this study's own registry entry says, in plain language.
- Phase
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Not a phased trial
Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.
- Participants
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About 235 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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May 2025
- Expected to finish
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Apr 2028
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 years and older
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: Each participant must meet all of the following criteria to be enrolled in this trial: * Living in Australia or the United States * Aged 18 years or older * Body Mass Index (BMI) \[Equation\]18.5kg/m2 and \[Equation\] 34.9kg/m2 * Diagnosed with IBS by a General Practitioner, Family Physician, or Gastroenterologist, or Advanced Specialist Dietitian * Currently fulfill Rome IV criteria for IBS * Symptomatic at the time of recruitment (IBS-SSS \> 175) * Access to a computer and internet * Sufficient English language and computer skills to complete a text-based online treatment * Willing to make dietary or behavioral changes in line with the allocated treatment program * Ability to provide informed consent Exclusion Criteria:Patients meeting any of the following criteria will be excluded from the trial: * Presence or known history of other GI disease (e.g. coeliac disease, Inflammatory Bowel Disease) or history of gastrointestinal cancer * History of major gastrointestinal surgery (not appendectomy, cholecystectomy or hemorrhoidectomy) * Individuals who report alarm symptoms (e.g., blood in stool, recent unexplained/unintentional weight loss \>5% body weight, a recent change in bowel habits if \>50 years, family history of gastrointestinal cancer or gastrointestinal diseases, large volumes of diarrhea occurring at night, fever associated with gut symptoms, recurrent vomiting, persistent unexplained iron deficiency) will be excluded if appropriate medical investigations have not been conducted, unless written medical approval is provided from a general practitioner, family physical, or gastroenterologist. * Diagnosis of major disease that could explain current gastrointestinal symptoms such as severe diabetic, cardiac, liver, neurological, neuropathy disease * History or current diagnosis of psychotic disorder or bipolar disorder * Current diagnosis of substance abuse disorder or major depressive disorder or active suicidal ideation * History or current diagnosis of an eating disorder * Current enteral/parenteral feeding or use of supplemental feeds (e.g. Ensure) * Pregnant or lactating or planning to become pregnant during the 12-week intervention period * Commenced or change in dose of antibiotics and medications that potentially affect the gastrointestinal transit (e.g. anti-diarrheals and laxatives) in the 3 months preceding study commencement. * Commenced taking or changed dose of probiotics, prebiotics, fibre supplements and digestive enzymes in the 3 months preceding study commencement * Commenced or change dose in psychotropic medication in the 3 months preceding study commencement * Are currently undertaking behavioral therapy for IBS (including cognitive behavioral therapy, CBT), or have undertaken clinician-delivered behavioral therapy for the treatment of IBS * Are currently undertaking or have undertaken a dietitian-prescribed and delivered restrictive diet for IBS (e.g., FODMAP diet).
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
1 site. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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University of Melbourne
RECRUITINGMelbourne, Victoria, 3010, Australia
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Other studies related to the condition(s) this trial covers.
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- Could an Anti-Inflammatory diet designed for Crohn's disease also tame IBS?