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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: |
NCT02538354 |
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Date of registration:
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20/08/2015 |
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Prospective Registration:
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Yes |
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Primary sponsor: |
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Public title:
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The Effect of Riboflavin in Crohn's Disease
RISE-UP |
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Scientific title:
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The Effect of Riboflavin Supplementation on Faecalibacterium Prausnitzii in Crohn's Disease |
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Date of first enrolment:
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March 2016 |
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Target sample size:
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70 |
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Recruitment status: |
Completed |
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URL:
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https://clinicaltrials.gov/show/NCT02538354 |
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Study type:
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Interventional |
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Study design:
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Allocation: Non-Randomized. Intervention model: Parallel Assignment. Primary purpose: Other. Masking: None (Open Label).
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Phase:
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N/A
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Countries of recruitment
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Netherlands
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Key inclusion & exclusion criteria
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Inclusion Criteria:
- Crohn's disease patients
- Age 18-65 years
- Concomitant medication for Crohn's disease is allowed in all groups
Exclusion Criteria:
- Swallowing disorders
- Pregnancy and lactation
- Use of antibiotic drugs, probiotics (i.e.Yakult, Vifit, Activia etc) or specific
prebiotic supplements in the 3 weeks prior to the riboflavin intervention
- Use of Methotrexate drugs
- Colonoscopy and colon cleansing in last 3 months
- Use of a vitamin B2 supplement, or multivitamin complexes containing vitamin B (i.e.
vitamin B-complex) in the 3 weeks prior to the riboflavin intervention
- Severe Crohn's disease (HBI > 12)
Age minimum:
18 Years
Age maximum:
65 Years
Gender:
All
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Health Condition(s) or Problem(s) studied
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Crohn Disease
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Intervention(s)
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Dietary Supplement: Riboflavin supplementation
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Primary Outcome(s)
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F. Prausnitzii (FISH Analysis).
[Time Frame: Different time points up to 6 weeks from start study: Day0, Day7, Day28]
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Secondary ID(s)
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Protocol ID
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METc 2014/291
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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