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New treatment option for Irritable Bowel Syndrome (IBS)
Official title Exclude or Expose in Irritable Bowel Syndrome: What Works for Whom and How?
ClinicalTrials.gov ID: NCT06940596
What this study is testing
- What it's testing
- This research project will assess how two treatments for irritable bowel syndrome (one dietary and one behavioral) work and for whom. This will be done by assessing moderators (what treatment works for who and in what context) and mediators (how treatment works).
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- 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
You likely can't join if
- 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...
- Diagnosis of major disease that could explain current gastrointestinal symptoms such as severe diabetic, cardiac, liver, neurological, neuropathy...
- History or current diagnosis of psychotic disorder or bipolar disorder
See the full eligibility 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
- 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...
- 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).
The study team makes the final eligibility decision.
Where it's taking place
- Melbourne, Victoria, Australia
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Melbourne, Victoria, Australia. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.