Status:
UNKNOWN
Lactobacillus Reuteri ATCC PTA 4659 in Ulcerative Colitis
Lead Sponsor:
Uppsala University
Conditions:
Ulcerative Colitis Flare
Eligibility:
All Genders
18-80 years
Phase:
PHASE2
Brief Summary
Explorative investigation to study the effect of the endogenous bacterium Lactobacillus reuteri ATCC PTA 4659 as a nutrient additive against relapse in ulcerative colitis. Forty patients will be studi...
Detailed Description
Research question To study whether dietary supplementation with L. reuteri ATCC PTA 4659 (Lr4659) is safe and can reduce the relapse rate and have a positive effect in patients with ulcerative colitis...
Eligibility Criteria
Inclusion
- Diagnosis of UC confirmed by biopsy
- Mayo full score \< 2
- Total or left-sided UC
- Stable diagnose of UC \>1 year
- History of more than 1 yearly recurrence
- Current remission period exceeding 2 months
- 18-75 years of age
- Baseline 5-ASA ≤2g daily
- Mentally fit to participate
- Informed consent obtained
Exclusion
- Crohn's disease
- Ulcerative proctitis
- Infective colitis
- Liver disease
- Current use of probiotics
- Current medication acetylsalicylic acid (ASA), non-steroidal antiinflammatory drugs (NSAID), corticosteroids, anticoagulants, serotonin-selective re-uptake inhibitors (SSRI), serotonin-noradrenaline re-uptake inhibitors (SNRI), azathioprine (AZA), 6-mercaptopurin (6-MP), thioguanin (TG), anti-TNF-alpha biologicals
- Participation in other clinical trials
Key Trial Info
Start Date :
January 1 2017
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
March 1 2019
Estimated Enrollment :
40 Patients enrolled
Trial Details
Trial ID
NCT03798210
Start Date
January 1 2017
End Date
March 1 2019
Last Update
January 14 2019
Active Locations (1)
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1
Uppsala University
Uppsala, Sweden, 75185