None listed
Conditions
Brief summary
The low FODMAP diet is an effective symptom management approach for 50-75% of individuals with irritable bowel syndrome (IBS), leaving 25-50% as non-responders. Determining predictors of treatment response at the individual level during all three-phases of the low FODMAP diet are lacking. The aim was to investigate predictors of symptom response to the low FODMAP diet in patients with IBS. Adult IBS participants undertook the low FODMAP diet via one-on-one dietetic education including elimination, reintroduction and personalisation phases. Predictor variables included levels of depressive, anxiety, and extraintestinal somatic symptoms, stress, treatment beliefs and expectations, behavioural avoidance, and illness perceptions. Symptom severity and quality of life were the outcome variables. Questionnaires assessing psychological predictors, symptoms and QoL were completed at five timepoints: pre-dietitian (week 0), immediately post-dietitian, at the end of the elimination (week 5), reintroduction (week 13) and personalisation (week 25) phases. Statistical analyses will assess the predictive relationships between psychological predictors and symptom severity.
Interventions
The intervention is the low fermentable oligosaccharides, disaccharides, monosaccharides and polyols (FODMAP) diet.
The intervention will be delivered via online (60-45 minute zooms) one-on-one consults with a dietitian who has experience with gastrointestinal disorders and delivery of the low FODMAP diet.
Consults will be conducted at 3 timepoints: week 0 (pre-Phase 1), week 5 (following completion of Phase 1), week 13 (following completion of Phase 2 and prior to commencing Phase 3).
The edu
The intervention is the low fermentable oligosaccharides, disaccharides, monosaccharides and polyols (FODMAP) diet. The intervention will be delivered via online (60-45 minute zooms) one-on-one consults with a dietitian who has experience with gastrointestinal disorders and delivery of the low FODMAP diet. Consults will be conducted at 3 timepoints: week 0 (pre-Phase 1), week 5 (following completion of Phase 1), week 13 (following completion of Phase 2 and prior to commencing Phase 3). The education will follow the FODMAP implementation guidelines including elimination, reintroduction and personalisation phases. Phase 1 Elimination: The education will focus on foods within the patients’ diets that are known to be high in FODMAPs and offering an explanation as to why these foods cause the symptoms related to irritable bowel syndrome (IBS). The patient will be instructed to follow a low FODMAP diet and the dietitian will provide resources that are suitable to the patient they are seeing (e.g. low FODMAP shopping lists, meal plan, food swaps). The elimination period will be followed for 4-weeks. Phase 2 Reintroduction: Education will focus on continuation of the low FODMAP diet with reintroduction of FODMAPs, where FODMAP-containing foods are used as challenges. Challenge foods are consumed in increasing amounts over 3 days. A symptom diary is kept to document symptoms and responses to each food, to allow determination of the individuals’ threshold to that FODMAP. A three-day washout of the low FODMAP diet is followed before another challenge occurs. The reintroduction phase will be followed for 2-months. Phase 3 Personalisation: Education will focus on including higher FODMAP containing foods that did not induce symptoms in the diet whilst maintaining symptom relief and increasing variety in the diet. The personalisation phase will be followed for 3-months. The total duration of the study participation and 3-phase intervention is 25 weeks. Adherence is monitored via completion of food frequency questionnaire at each timepoint and attendance at each of the 3 dietetic consults.
Sponsors
La Trobe University
Study design
Allocation
Non-randomised trial
Intervention model
Single group
Primary purpose
Treatment
Masking
Open (masking not used)
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
Adults who has not yet seen a dietitian for IBS management who had symptoms characterised by the Rome IV criteria, good English literacy skills, stable medication use or stable ongoing psychological therapies in the 12 weeks prior to commencing the study.
Exclusion criteria
Pregnant women, paediatrics (<18 years old) and those with gastrointestinal symptoms not pertaining to the Rome IV criteria (such as inflammatory bowel disease, coeliac or dyspepsia).
Outcome results
None listed