None listed
Conditions
Brief summary
There are two parts to this protocol. 1. An observational study comparing characteristics of participants who had IBS with diarrhea or IBS (M) with and without SIBO. 2. A randomised dietary education trial where participants with SIBO receive education on either a low FODMAP diet or a diet low in FODMAP, fat, sugar and avoiding snacking. This registration is for the RCT only. We will be registering the observational study separately. Potential participants with IBS will be invited to participate. After signing a consent form participants will complete an IBS symptom severity scoring system (1), an IBS quality of life questionnaire (2), the hospital anxiety and depression index (3), a visual analogue scale for flatulence (0-100), a general health questionnaire, a physical activity questionnaire and “trigger” foods questionnaire online via REDCAP (Research electronic data capture), They will complete a separate food frequency questionnaires (FFQ) online (the DHQ measuring intake over the last year). Participants will complete anthropometric measures, and give urine, blood and fecal samples. They will be screened for SIBO using breath tests with 75g glucose in 200ml water as the substrate. A positive breath test is defined as an increase of =>12ppm hydrogen and methane from baseline. Blood samples will be analysed for serum B12, serum vitamin A, cholesterol, iron studies, and haemoglobin. For participants without SIBO this currently is the end of the study. We will be including their data within publications that may be produced as a part of the overall study. Should we recruit a sufficient sample this will be a large IBS population for which we will analyse the microbiome and metabolome using next generation sequencing techniques. Those with SIBO will have a one month “run in” period before being provided with the dietary education. Participants will be randomised to either a low FODMAP diet education or a low FODMAP plus low sugar, reduced fat and avoiding of snacking. Data will be recollected at 2 months after which time the participants will begin the food rechallenges. The final data collection point will be a six months after the commencement of dietary education when participants should have liberalised their diet according to their individual tolerances. Faecal samples and urine samples will be stored at -80C until processed and analysed. DNA will be extracted and sequenced using next generation sequencing techniques. Urine samples will be analysed for metabolites using liquid chromatography (LC/MS) and gas chromatography (GC/MS). Data generated from the microbiome and metabolome analysis will be analysed using a compositional data analysis techniques.
Interventions
Participants with small intestinal bacterial overgrowth (SIBO) will be randomized to one of two dietary education protocols. Either a low FODMAP (as per the Monash University low FODMAP app) or a low FODMAP, low sugar (<5% of total energy to come from free sugar), reduced fat diet (<25% of total energy) and instructed to avoiding snacking. In both diets participants are to avoid all high FODMAP foods.
There is a one month "run in" period before the participants receive their dietary education w
Participants with small intestinal bacterial overgrowth (SIBO) will be randomized to one of two dietary education protocols. Either a low FODMAP (as per the Monash University low FODMAP app) or a low FODMAP, low sugar (<5% of total energy to come from free sugar), reduced fat diet (<25% of total energy) and instructed to avoiding snacking. In both diets participants are to avoid all high FODMAP foods. There is a one month "run in" period before the participants receive their dietary education where participants will eat their usual diet.. This is to control for the natural variation in the microbiome. Participants will be seen by a NZ registered dietitian with 10 years experience. All dietary education sessions will be conducted with the dietitian individually. Participants in each group will receive an initial 1 hour session with the dietitian. At this session they will receive a written handout explaining the diet and containing lists of food and a separate recipe book. (The handouts will be different between groups.) They will have an optional second 30 minute education session in the intensive phase (this is when participant's are asked to significantly reduce all FODMAP molecules). After the 2 month data collection they will have a 30 minutes session with the dietitian on rechallenging foods to tolerance. This session will be accompanied by a second handout. They will have the option of another 1 session discussing the process of food rechallenges (four weeks after the initial rechallenge education).The overall duration of the intervention period is 6 months. All patient education will be conducted face to face in a healthcare setting at St Joseph's Hospital, London, Ontario. Timeline for diets Baseline to end of "run in" period; follow usual diet End of "run in" period to 2 month data collection: on the intensive phase of the diet 2 month to 6 month data collection: participants are rechallenging foods and then following the diet that they are able to tolerate. Adherence to the diet will be measured by 8 telephone diet recalls conducted by two nutrition students. They will be checking for evidence of high FODMAP food intake and reporting on this.
Sponsors
Michael Schultz
Study design
Allocation
Randomised controlled trial
Primary purpose
Treatment
Masking
Open (masking not used)
Eligibility
Sex/Gender
All
Age
18 Years to 65 Years
Healthy volunteers
No
Inclusion criteria
IBS (D) or IBS (M) according to Rome III and fluent in English
Exclusion criteria
Organic gastrointestinal disease (e.g. coeliac, IBD), Diabetes, Serious neurological or respiratory conditions Previous gastrointestinal surgery (except appendectomy), Pancreatitis, Previous radiotherapy to the abdominal area or chemotherapy, Pregnancy and lactation, Antibiotics or probiotics within the last 6 weeks,
Outcome results
None listed