None listed
Conditions
Brief summary
The aim of this research project is to evaluate proof of concept - change in mechanistic and clinical outcomes, and feasibility and acceptability of a newly developed online FODMAP (LFD) diet intervention. The FODMAP diet is an evidence-based therapy and first-line intervention for the management of IBS. The specific aims of this research are: To evaluate if the online FODMAP diet program can achieve a pre-specified minimally clinically important change (MCIC) in: i. Total FODMAP intake; and ii. Gastrointestinal IBS symptoms. To evaluate if the online FODMAP diet program can be implemented as designed specifically addressing: i. recruitment, ii. trial processes and procedures including completion of primary outcome measures, participant engagement with the program, and therapist intervention; and ii. program acceptability. We hypothesise that the online FODMAP diet program will achieve a clinically meaningful change in total FODMAP intake and gastrointestinal IBS symptom improvement; and that the online FODMAP diet program will be feasible and acceptable to participants as indicated by meeting a priori identified benchmarks. We anticipate that the post treatment qualitative interviews will facilitate further refinement and optimisation of the online treatment prior to conducting the proposed randomised controlled trial.
Interventions
The online diet program is based on an evidence-based diet, recommended as first or second line therapy in irritable bowel syndrome. The diet is the low FODMAP (fermentable, oligosaccharides, disaccharides, monosaccharides and polyols) diet. It is a 3-phase diet which involves:
• Phase 1 FODMAP restriction – restricting foods high or moderate in fructans (e.g., wheat products, onions), galacto-oligosaccharides (e.g., legumes), lactose (e.g., cows’ milk), excess fructose (e.g., honey), and polyol
The online diet program is based on an evidence-based diet, recommended as first or second line therapy in irritable bowel syndrome. The diet is the low FODMAP (fermentable, oligosaccharides, disaccharides, monosaccharides and polyols) diet. It is a 3-phase diet which involves: • Phase 1 FODMAP restriction – restricting foods high or moderate in fructans (e.g., wheat products, onions), galacto-oligosaccharides (e.g., legumes), lactose (e.g., cows’ milk), excess fructose (e.g., honey), and polyols (e.g., pear, sugar-free gum); and swapping these for low FODMAP alternatives. • Phase 2 FODMAP reintroduction – continuing to follow a low FODMAP diet and completing a series of food challenges to help understand which foods and FODMAPs are tolerated and which trigger symptoms • Phase 3 FODMAP personalisation – including well tolerated foods and FODMAPs back into the diet, while restricting poorly tolerated foods and FODMAPs to a level needed to maintain symptom relief. The online diet program is a self-directed program implemented over 12 weeks, with an online therapist (dietitian) to guide participants through the program. The content of the online FODMAP diet program is organised into six Steps to be completed over the 12-week program duration and is delivered via the e-learning platform CANVAS. Participants are provided with a link to the CANVAS platform (and access to the online diet program) by the primary researcher. The program provides all the information that participants require to follow the 3-phase FODMAP diet. They are not provided with any food or meals as part of the online diet education program. Participants access each Step individually. They are instructed to complete one module per week over the 12-week course (i.e. 12 modules). The first two Steps are completed in weeks 1 and 2 (module 1 and 2). Step 1 provides a background understanding of IBS and the FODMAP diet and Step 2 describes Phase 1 of the FODMAP diet. Steps 3, 4 and 5 describe and guide participants through the implementation of the 3-phase FODMAP diet (Phase 1 restriction; Phase 2 reintroduction; and Phase 3 personalisation). Step 3 is completed weeks 3-6 (modules 3-6) and Steps 4 and 5 are completed weeks 7-11 (modules 7-11) of the program. Step 6 of the program is completed in the final week (week 12 - module 12) and provides information to empower participants to manage their IBS and their personalised FODMAP diet after the online program is finished. Each Step of the program consists of information provided as text, image-based information, and as downloadable handouts/worksheets. Some steps also include interactive activities (e.g. written reflection prompts, draggable questions and knowledge check questions). At the completion of each module participants will be directed to complete homework activities and questions and submit to the dietitian for feedback. Submission of homework activities and questions is required for access to successive modules. If participants do not complete a module and/or submit related homework, the program administrator (study primary researcher) will send a reminder one day and four days after the recommended date of completion. Participants will also be able to ask the dietitian questions at any time throughout the program. The therapist (dietitian) will respond to participant homework activities and questions within 2 days of submission. Feedback provided will be guided by a response message bank developed a priori by the primary researcher (JA) and the online therapist (dietitian) for the feasibility study.
Sponsors
Monash University
Study design
Allocation
Non-randomised trial
Primary purpose
Treatment
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
No
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
Outcome results
None listed