Status:
COMPLETED
Lactobacillus Rhamnosus GG (ATCC 53103) in Mild-moderately Active UC Patients
Lead Sponsor:
San Giovanni Addolorata Hospital
Collaborating Sponsors:
Onlus S. Andrea
Conditions:
Ulcerative Colitis Chronic Mild
Ulcerative Colitis Chronic Moderate
Eligibility:
All Genders
18-65 years
Phase:
PHASE1
PHASE2
Brief Summary
This study is a randomized double-blind clinical trial that intends to evaluate the efficacy and safety of LGG administration at two different doses, for 1 month, in ulcerative colitis (UC) patients w...
Detailed Description
Probiotic bacteria have been proposed as therapeutic option in several pathologic conditions, but their utilization is often not evidence-based driven. In inflammatory bowel disease (IBD), consistent ...
Eligibility Criteria
Inclusion
- firm diagnosis of UC (clinical, endoscopic and histological criteria) from at least 1 year
- mild-moderate clinical activity (Clinical Mayo score 2-4)
- patient taking oral mesalamine
- Informed consent obtained and signed at the screening visit (T-1)
Exclusion
- Pregnant women
- Serious co-morbidities (i.e. autoimmune pathologies, cancer, chronic infectious conditions, immunocompromised patients)
- Patients at first diagnosis of UC
- Patients with current immunosuppressive and/or biologic therapy for IBD, or who had immunosuppressive and/or biologic therapy for IBD in the last year
- Patients with current oral and/or topical steroid therapy, or who had oral steroid therapy for disease flare in the last 6 months
- Patients with current topical UC therapy (suppositories, enemas, foams)
- Patients with current antibiotic/probiotic therapy, or who had antibiotic/probiotic therapy in the last 3 months
Key Trial Info
Start Date :
September 30 2019
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 31 2022
Estimated Enrollment :
76 Patients enrolled
Trial Details
Trial ID
NCT04102852
Start Date
September 30 2019
End Date
January 31 2022
Last Update
October 26 2022
Active Locations (1)
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1
S. Giovanni Addolorata Hospital
Roma, Italy, 00184