Tritordeum-based Foods for IBS Symptoms

NCT05307185 | Completed

• 1 other identifier: TRITOIBS22
• Study Type: interventional
• Target: 135
• Locations: 1 country
• Sites: 1

Brief Summary

People with irritable bowel syndrome (IBS), especially those with diarrhea (IBS-D), often describe worsening symptoms after eating certain foods. A structured dietary approach may represent a reliable strategy to improve their symptoms. In this framework, the diet low in oligosaccharides, disaccharides, monosaccharides, and fermentable polyols (FODMAPs - LFD) has been demonstrated to mitigate symptoms and reduce inflammatory status, increase vitamin D content, and affect the lipidomic profile. Unfortunately, adherence to LFD can be somewhat problematic, needing continuous nutritional support. Other dietary approaches with putative beneficial effects have been proposed to overcome these limitations. Among them, Tritordeum-based foods (TBD, bread, bakery products, and pasta) in substitution of other cereals seem to achieve promising results. TBD may represent a valid alternative, with high palatability, especially among Italian patients for whom pasta is considered one of the main assets of dietetic culture and easier to manage in their daily habits. Given these premises, this study aims to evaluate, in a randomized single-blinded controlled trial, the effects of 12-weeks of TBD compared with LFD and dietary advice of the same duration in improving the symptom profile well as the intestinal permeability and reducing putative dysbiosis of IBS-D patients. Along with the clinical study, an evaluation of gluten and proteomic composition will be performed to examine more in detail the intrinsic characteristics of Tritordeum.

Conditions

Irritable Bowel Syndrome

Keywords

IBS; Diarrhea; Diet; FODMAPs; Tritordeum; Intestinal permeability; Symptoms; Dysbiosis; Gluten

Outcome Measures

Primary Outcomes (1)

• Change in the total score of the irritable bowel syndrome - severity scoring system (IBS-SSS) questionnaire

  IBS-SSS contains 5 specific questions with instructions on how to score them. Each of the five questions (pain severity, pain frequency, abdominal distension severity, bowel movement satisfaction, quality of life) ranges from 0 to a maximum score of 100 using a visual analog scale (VAS), leading to a total possible score of 500. The primary outcome corresponds to a change in the total score of the IBS-SSS questionnaire at the end of the treatment period compared to baseline, and the proportion of patients who will achieve a difference in the total symptom score of IBS-SSS ≥50 after diet. Such difference is considered a significant clinical improvement.

  Before the start of the study (time 0) and after 90 days of treatment (time 90).

Secondary Outcomes (4)

• Change in the score of the single symptom items of the irritable bowel syndrome - severity scoring system (IBS-SSS) questionnaire

  Before the start of the study (time 0) and after 90 days of treatment (time 90).

• Change in the psychological symptom profile evaluated by Symptom Checklist-90- Revised (SCL-90-R)

  Before the start of the study (time 0) and after 90 days of treatment (time 90).

• Change in the intestinal permeabily parameters of sugar absorption test

  Before the start of the study (time 0) and after 90 days of treatment (time 90).

• Change in the markers of integrity of the intestinal barrier

  Before the start of the study (time 0) and after 90 days of treatment (time 90).

Study Arms (3)

Tritordeum-based Food (TBD)

EXPERIMENTAL

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.

Dietary Supplement: Tritordeum-based food

Low-FODMAPs diet (LFD)

ACTIVE COMPARATOR

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.

Dietary Supplement: Tritordeum-based food

Specific dietary advice for IBS

ACTIVE COMPARATOR

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.

Dietary Supplement: Tritordeum-based food

Interventions

Tritordeum-based food DIETARY_SUPPLEMENT

Diets will last 12 weeks with intermediate nutritional checks every four weeks before returning to the final study visit.

Low-FODMAPs diet (LFD); Specific dietary advice for IBS; Tritordeum-based Food (TBD)

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.
• Patients must be willing to change their current diet to participate in the study for the whole study period.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Azienda Ospedaliera Specializzata in Gastroenterologia Saverio de Bellis: lead

Study Sites (1)

IRCCS Saverio de Bellis

Castellana Grotte, Bari, 70013, Italy

Location

Related Publications (8)

• Tuck CJ, Reed DE, Muir JG, Vanner SJ. Implementation of the low FODMAP diet in functional gastrointestinal symptoms: A real-world experience. Neurogastroenterol Motil. 2020 Jan;32(1):e13730. doi: 10.1111/nmo.13730. Epub 2019 Sep 30.

  PMID: 31571351 BACKGROUND

• Linsalata M, Riezzo G, Orlando A, D'Attoma B, Prospero L, Tutino V, Notarnicola M, Russo F. The Relationship between Low Serum Vitamin D Levels and Altered Intestinal Barrier Function in Patients with IBS Diarrhoea Undergoing a Long-Term Low-FODMAP Diet: Novel Observations from a Clinical Trial. Nutrients. 2021 Mar 21;13(3):1011. doi: 10.3390/nu13031011.

  PMID: 33801020 BACKGROUND

• Orlando A, Tutino V, Notarnicola M, Riezzo G, Linsalata M, Clemente C, Prospero L, Martulli M, D'Attoma B, De Nunzio V, Russo F. Improved Symptom Profiles and Minimal Inflammation in IBS-D Patients Undergoing a Long-Term Low-FODMAP Diet: A Lipidomic Perspective. Nutrients. 2020 Jun 2;12(6):1652. doi: 10.3390/nu12061652.

  PMID: 32498383 BACKGROUND

• Avila CM, Rodriguez-Suarez C, Atienza SG. Tritordeum: Creating a New Crop Species-The Successful Use of Plant Genetic Resources. Plants (Basel). 2021 May 20;10(5):1029. doi: 10.3390/plants10051029.

  PMID: 34065483 BACKGROUND

• Vaquero L, Comino I, Vivas S, Rodriguez-Martin L, Gimenez MJ, Pastor J, Sousa C, Barro F. Tritordeum: a novel cereal for food processing with good acceptability and significant reduction in gluten immunogenic peptides in comparison with wheat. J Sci Food Agric. 2018 Apr;98(6):2201-2209. doi: 10.1002/jsfa.8705. Epub 2017 Nov 9.

  PMID: 28963718 BACKGROUND

• Rotondi Aufiero V, Fasano A, Mazzarella G. Non-Celiac Gluten Sensitivity: How Its Gut Immune Activation and Potential Dietary Management Differ from Celiac Disease. Mol Nutr Food Res. 2018 May;62(9):e1700854. doi: 10.1002/mnfr.201700854. Epub 2018 Apr 20.

  PMID: 29578652 BACKGROUND

• Barmeyer C, Schumann M, Meyer T, Zielinski C, Zuberbier T, Siegmund B, Schulzke JD, Daum S, Ullrich R. Long-term response to gluten-free diet as evidence for non-celiac wheat sensitivity in one third of patients with diarrhea-dominant and mixed-type irritable bowel syndrome. Int J Colorectal Dis. 2017 Jan;32(1):29-39. doi: 10.1007/s00384-016-2663-x. Epub 2016 Sep 30.

  PMID: 27695975 BACKGROUND

• Russo F, Riezzo G, Linsalata M, Orlando A, Tutino V, Prospero L, D'Attoma B, Giannelli G. Managing Symptom Profile of IBS-D Patients With Tritordeum-Based Foods: Results From a Pilot Study. Front Nutr. 2022 Feb 15;9:797192. doi: 10.3389/fnut.2022.797192. eCollection 2022.

  PMID: 35242794 BACKGROUND

MeSH Terms

Conditions

Irritable Bowel Syndrome; Diarrhea; Dysbiosis

Condition Hierarchy (Ancestors)

Colonic Diseases, Functional; Colonic Diseases; Intestinal Diseases; Gastrointestinal Diseases; Digestive System Diseases; Signs and Symptoms, Digestive; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Pathologic Processes

Study Officials

• Francesco Russo, MD

  National Institute for Digestive Diseases IRCCS " Saverio de Bellis"

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: The investigator, but not the patients will know the real identity of the treatment assignment (food preparation and packaging will be unlabelled and not recognizable).
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Coordinating Medical Director Functional GI Disorders Research Group

Model Details: Multi-disciplinary, single-blind, parallel-group randomized controlled trial design

Study Record Dates

• First Submitted: March 23, 2022
• First Posted: April 1, 2022
• Study Start: January 17, 2022
• Primary Completion: December 31, 2024
• Study Completion: March 30, 2025
• Last Updated: March 25, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

IT (1)