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. |
Register:
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ClinicalTrials.gov |
Last refreshed on:
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12 December 2020 |
Main ID: |
NCT01065571 |
Date of registration:
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04/02/2010 |
Prospective Registration:
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No |
Primary sponsor: |
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Public title:
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Effects of Carrageenan-Elimination Diet on Ulcerative Colitis Disease Activity
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Scientific title:
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Effects of Carrageenan-Elimination Diet on Ulcerative Colitis Disease Activity |
Date of first enrolment:
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January 2010 |
Target sample size:
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15 |
Recruitment status: |
Completed |
URL:
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https://clinicaltrials.gov/show/NCT01065571 |
Study type:
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Interventional |
Study design:
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Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Other. Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor).
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Phase:
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N/A
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Countries of recruitment
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United States
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Contacts
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Name:
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Joanne Tobacman, M.D. |
Address:
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Telephone:
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Email:
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Affiliation:
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University of Illinois at Chicago |
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Key inclusion & exclusion criteria
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Inclusion Criteria:
- Ulcerative colitis
- Adult
- In remission
- Required corticosteroids to induce remission
- Able to make food choices and follow diet
Exclusion Criteria:
- Not able to make food choices
Age minimum:
18 Years
Age maximum:
N/A
Gender:
All
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Health Condition(s) or Problem(s) studied
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Ulcerative Colitis
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Intervention(s)
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Dietary Supplement: carrageenan
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Other: dietary intervention with no-carrageenan diet
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Primary Outcome(s)
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Number of Relapses by Group
[Time Frame: up to one year of participation for each enrolled subject]
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Secondary Outcome(s)
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Serum Interleukin-6 (pg/ml)
[Time Frame: change in IL-6 between baseline and up to one year of study participation]
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Fecal Calprotectin (Microgram/Gram Stool)
[Time Frame: one year or relapse or withdrawal compared with baseline]
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Secondary ID(s)
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2009-0073
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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