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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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12 December 2020 |
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Main ID: |
NCT03798210 |
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Date of registration:
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07/01/2019 |
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Prospective Registration:
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No |
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Primary sponsor: |
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Public title:
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Lactobacillus Reuteri ATCC PTA 4659 in Ulcerative Colitis
COLUS |
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Scientific title:
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The Effect of Lactobacillus Reuteri ATCC PTA 4659 in Patients With Ulcerative Colitis |
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Date of first enrolment:
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January 1, 2017 |
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Target sample size:
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40 |
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Recruitment status: |
Recruiting |
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URL:
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https://clinicaltrials.gov/show/NCT03798210 |
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Study type:
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Interventional |
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Study design:
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Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Prevention. Masking: Triple (Participant, Care Provider, Investigator).
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Phase:
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Phase 2
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Countries of recruitment
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Sweden
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Contacts
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Name:
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Per M Hellström, Prof |
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Address:
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Telephone:
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+46 70 3727423 |
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Email:
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per.hellstrom@medsci.uu.se |
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Affiliation:
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Name:
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Per M Hellström, Prof |
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Address:
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Telephone:
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Email:
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Affiliation:
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Uppsala University |
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Name:
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Per M Hellström, Prof |
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Address:
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Telephone:
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+46 70 3727423 |
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Email:
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per.hellstrom@medsci.uu.se |
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Affiliation:
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Key inclusion & exclusion criteria
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Inclusion Criteria:
- 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 Criteria:
- 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
Age minimum:
18 Years
Age maximum:
80 Years
Gender:
All
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Health Condition(s) or Problem(s) studied
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Ulcerative Colitis Flare
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Intervention(s)
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Dietary Supplement: Placebo
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Dietary Supplement: Lactobacillus reuteri
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Primary Outcome(s)
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Rectal bleeding with Mayo score =5
[Time Frame: 12 months]
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Secondary Outcome(s)
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Increased CRP
[Time Frame: 12 months]
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Increased fecal calprotectin
[Time Frame: 12 months]
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Secondary ID(s)
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ATCC PTA 4659
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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