Status:
COMPLETED
Analysis of Microbiota Changes Induced by Microencapsulated Sodium Butyrate in Patients With Inflammatory Bowel Disease
Lead Sponsor:
University of Padova
Conditions:
Inflammatory Bowel Diseases
Irritable Bowel Syndrome
Eligibility:
All Genders
18-75 years
Phase:
NA
Brief Summary
Inflammatory bowel disease (IBD) is characterized by severe inflammation of the small bowel and/or the colon leading to recurrent diarrhea and abdominal pain. Irritable Bowel Syndrome with diarrhea (...
Detailed Description
The IBDMicro is an interventional, randomized, double-blind, placebo-controlled study. A novel oral formulation of butyrate contained in a lipophilic microcapsule, that provides extensive capacity for...
Eligibility Criteria
Inclusion
- Patients with histologically confirmed diagnosis of Crohn disease (CD) or Ulcerative colitis (UC) in the last 6 months and undergoing followup colonoscopy.
Exclusion
- (a) prior proctocolectomy;
- (b) presence of IBD extraintestinal manifestation;
- (c) treatment with antibiotics in the last 60 days;
- (d) extensive surgical resection;
- (e) presence of stoma.
Key Trial Info
Start Date :
June 1 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 30 2022
Estimated Enrollment :
160 Patients enrolled
Trial Details
Trial ID
NCT04879914
Start Date
June 1 2020
End Date
September 30 2022
Last Update
November 3 2022
Active Locations (1)
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1
Edoardo Vinvenzo Savarino
Padua, Italy, 35128