Tritordeum-based Foods for IBS Symptoms (TritoinIBS)
Irritable Bowel Syndrome
About this trial
This is an interventional treatment trial for Irritable Bowel Syndrome focused on measuring IBS, Diarrhea, Diet, FODMAPs, Tritordeum, Intestinal permeability, Symptoms, Dysbiosis, Gluten
Eligibility Criteria
Inclusion Criteria:
- Rome IV criteria for IBS diarrhea variant (IBS-D).
- Low-lactose diet is allowed, provided that patients agree to keep this intake constant throughout the study period, except in the case of randomization in the treatment arm with a low-FODMAPs diet.
- The use of probiotic products is permitted, and patients who consume probiotic products must be instructed to continue taking the same amount previously taken throughout the study period.
- The drugs used to treat IBS, including antidepressants, will be admitted provided they are used regularly and have a stable dosage for at least one month prior to inclusion in the study.
- Patients must be willing to change their current diet to participate in the study for the whole study period.
Exclusion Criteria:
- Serious cardiac, hepatic, neurological or psychiatric diseases.
- GI diseases other than IBS (e.g., inflammatory bowel disease, celiac disease) that could explain current symptoms.
- Patients who previously had a low-content diet of particular substances (for example, low FODMAPs content, vegan diet, a gluten-free diet). - This last category of subjects will be able to return to the study provided they suspend the gluten-free diet until the symptoms reappear.
Sites / Locations
- IRCCS Saverio de Bellis
Arms of the Study
Arm 1
Arm 2
Arm 3
Experimental
Active Comparator
Active Comparator
Tritordeum-based Food (TBD)
Low-FODMAPs diet (LFD)
Specific dietary advice for IBS
A controlled TBD will be provided to each patient. The daily menu will be breakfast, mid-morning snacks, lunch, afternoon snacks, and dinner. This intervention diet implies that each patient in the study has to consume flour, bread, breakfast biscuits, taralli, and pasta prepared exclusively with Tritordeum. The diets will be designed by matching basal metabolism and daily energy consumption with anthropometric data of all patients to assign suitable and tailored dietary regimens. The software utilized to assess the daily intake of macronutrients (50% carbohydrates, 30% lipids, and 20% proteins) will be the same as LFD.
A personalized LFD will be assigned after reviewing a food diary and having a one-on-one personal consultation with a nutritionist. Diet will match the basal metabolic rate and daily energy expenditure. A detailed weekly structured menu based on three meals (breakfast, lunch, and dinner) and two snacks (morning and afternoon) will be provided. Patients also will receive a booklet detailing what foods are allowed, which foods to avoid and which foods to reduce based on the classifications used by Monash University and cut-off values for each FODMAPs subgroup. Nutritionists have already created a leaflet for patients in the study with details on where to buy specific products. Besides, nutritionists will guarantee adequate fiber intake, also offering advice on cooking without onions and garlic and other high-FODMAP foods. Drinking alcohol will not be recommended, although it is not high in FODMAPs.
According to NICE BDA Irritable bowel syndrome dietary advice, a controlled diet will be provided. All the food items (bread, pasta, "taralli" - local salty biscuits, and breakfast biscuits) will be prepared using durum wheat flour commercially available and anonymized to guarantee masking. Dietary recommendations include eating slowly, limiting alcohol, spicy food and fatty foods, caffeine, carbonated drinks; avoiding chewing gums and sweeteners containing polyols; small and frequent meals, stressful conditions.