Status:
UNKNOWN
Tritordeum-based Foods for IBS Symptoms
Lead Sponsor:
Azienda Ospedaliera Specializzata in Gastroenterologia Saverio de Bellis
Conditions:
Irritable Bowel Syndrome
Eligibility:
All Genders
18-65 years
Phase:
NA
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...
Detailed Description
A structured dietary approach could represent a reliable alternative strategy to treat patients with functional gastrointestinal disorders such as irritable bowel syndrome (IBS), mainly in its diarrhe...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
January 17 2022
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
March 1 2025
Estimated Enrollment :
135 Patients enrolled
Trial Details
Trial ID
NCT05307185
Start Date
January 17 2022
End Date
March 1 2025
Last Update
August 25 2023
Active Locations (1)
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1
IRCCS Saverio de Bellis
Castellana Grotte, Bari, Italy, 70013