Pilot testing of an online fermentable oligosaccharides, disaccharides, monosaccharides and polyols (FODMAP) intervention for adults with irritable bowel syndrome

Not Applicable

Active, not recruiting

• Conditions: Irritable bowel syndrome; Oral and Gastrointestinal - Other diseases of the mouth, teeth, oesophagus, digestive system including liver and colon

• Registration Number: ACTRN12624000551594
• Lead Sponsor: Monash University

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2024-05-01
• Last Update Posted: 29 July 2024

Recruitment & Eligibility

• Status: Active, not recruiting
• Sex: All
• Target Recruitment: 8

Inclusion Criteria

Adults aged 18 years or older with self-reported IBS which meets ROME IV criteria. Potential participants must be symptomatic at time of recruitment as indicated by a symptom severity score >75 measured using the IBS-SSS (IBS Symptom Severity Score)

Exclusion Criteria

•Presence or known history of other GI diseases i.e. coeliac disease or inflammatory bowel disease) or history of major GI surgery (except appendectomy or haemorrhoidectomy).
•Presence of major comorbidities that could explain current gastrointestinal symptoms i.e. severe diabetic, cardiac, liver, neurological, neuropathy disease.
•Alarm symptoms (e.g. blood in stool, rapid weight loss, nocturnal symptoms, recent change in bowel habits if >50 years) shown to predict presence of organic diseases.
•Less than 2 years of IBS symptoms regardless of when diagnosis given
•History or current diagnosis of anorexia nervosa, binge eating disorder or bulimia nervosa). Participants with avoidant/restrictive food intake disorder (ARFID) or milder forms of disordered eating may be included.
•History or current diagnosis of psychotic disorder or bipolar disorder; current diagnosis of substance abuse disorder or major depressive disorder or active suicidal ideation.
•Body Mass Index (BMI) < 18.5kg/m2
•Pregnant or lactating or plans to become pregnant during study duration
•Currently on a restriction/elimination diet for gastrointestinal symptoms (e.g. low FODMAP diet, gluten free diet) or have undertaken the 3-phase low FODMAP diet delivered by a dietitian within the last two years. Those following a lactose free diet will be eligible if they agree to keep intake consistent unless advised to reduce further.
•Current enteral/parenteral feeding or use of supplemental feeds (e.g. Ensure)
•Currently undertaking brain-gut behaviour therapy (e.g. gut-directed hypnotherapy; gut-directed psychotherapy; mindfulness-based stress reduction; mindfulness-based cognitive therapy). Participants engaged in regular stress reduction activities such as breathing exercises, psychology counselling, mindfulness, and/or physical activity will be encouraged to continue with these activities during the 12-week intervention program.
•Commenced or change in dose of IBS medications (e.g. antidepressants) in the three months preceding study commencement.
•Commenced or change in dose of antibiotics and medications that potentially affect the gastrointestinal transit (e.g. anti-diarrhoeals and laxatives) in the month preceding study commencement. Supplements such as probiotics, prebiotics, fibre supplements and digestive enzymes will be allowed, provided that participants have been on a stable dose for at least 1 month before inclusion.
•Not willing to change current diet or dietary supplement intake (e.g. fibre supplements)
•No access to internet or computer
•Insufficient language or computer skills to complete a text based online treatment.
•Inability to provide informed consent

Study & Design

• Study Type: Interventional
• Study Design: Not specified