None listed
Conditions
Brief summary
The aim is to compare the effectiveness of two widely used diets: (1) the RPAH low chemical elimination diet, and (2) the low FODMAP diet. Patients will be randomly allocated to a 3-week period on one of these diets, after which they will cross-over for a further 3 weeks on the other diet. The main outcome measure will be symptom response. In addition to keeping a standard daily food & symptom diary, participants will be asked to complete questionnaires before, during and after the intervention period to assess impact on quality of life. Their dietary intake will also be analysed by a dietitian to ensure ongoing nutritional adequacy.
Interventions
Randomised cross-over comparison of low-chemical (low salicylates, amines, glutamates, additives) with a low FODMAP (low fermentable oligo, di, mono-saccharides and polyols) diets. Each diet will run for 3 weeks and be administered by a dietitian. No washout period is required. Improvement in symptoms would be expected to some extent after 3 weeks and participants will be allowed time at the end of the second diet (where they will maintain a low chemical diet (and low FODMAP if indicated).
Randomised cross-over comparison of low-chemical (low salicylates, amines, glutamates, additives) with a low FODMAP (low fermentable oligo, di, mono-saccharides and polyols) diets. Each diet will run for 3 weeks and be administered by a dietitian. No washout period is required. Improvement in symptoms would be expected to some extent after 3 weeks and participants will be allowed time at the end of the second diet (where they will maintain a low chemical diet (and low FODMAP if indicated). If no improvement after 6 weeks, participants will be returned to a normal diet. Food diaries will be utilised throughout the protocol to monitor adherence and nutritional adequacy. As part of the study, participants would consult the dietitian at randomisation, and prior to cross-over (each 30-60min). Email and phone access to the dietitian is provided ongoing.
Sponsors
Royal Prince Alfred Hospital Allergy Unit
Study design
Allocation
Randomised controlled trial
Intervention model
Crossover
Primary purpose
Treatment
Masking
Open (masking not used)
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
Functional bowel disorder
Exclusion criteria
Active asthma, past asthma triggered by food or drinks, history of laryngeal oedema or anaphylactoid reactions, or other gastrointestinal disorders (e.g. inflammatory bowel disease, coeliac disease)
Outcome results
None listed