Status:
COMPLETED
Low FODMAPs Diet vs. Specific Dietary Advice in Patients With IBS Diarrheal Variant
Lead Sponsor:
Azienda Ospedaliera Specializzata in Gastroenterologia Saverio de Bellis
Conditions:
Irritable Bowel Syndrome
Eligibility:
All Genders
18-65 years
Phase:
NA
Brief Summary
A reduced content of FODMAPs (fermentable oligosaccharides, disaccharides, monosaccharides, and polyols) in the diet may be beneficial for patients with IBS diarrheal variant, but so far few randomize...
Detailed Description
Irritable Bowel Syndrome (IBS) is a functional gastrointestinal disease (GI) affecting 10% -20% of the population and is composed of abdominal pain/discomfort, in combination with alterations of the s...
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, gluten-free diet). - This last category of subjects will be able to return to the study provided they suspend the gluten-free diet until thes symptoms reappear.
Key Trial Info
Start Date :
February 5 2018
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 31 2020
Estimated Enrollment :
62 Patients enrolled
Trial Details
Trial ID
NCT03423069
Start Date
February 5 2018
End Date
December 31 2020
Last Update
March 22 2022
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
IRCCS Saverio de Bellis
Castellana Grotte, Bari, Italy, 70013