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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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9 May 2022 |
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Main ID: |
NCT02469220 |
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Date of registration:
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08/06/2015 |
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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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Diet Treatment of Patients With Ulcerative Colitis in Remission
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Scientific title:
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Diet Treatment of Patients With Ulcerative Colitis in Remission |
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Date of first enrolment:
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July 1, 2018 |
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Target sample size:
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19 |
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Recruitment status: |
Completed |
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URL:
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https://clinicaltrials.gov/show/NCT02469220 |
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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: Basic Science. 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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Denmark
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Contacts
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Name:
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Jeanette Soerensen, PhD-student |
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Address:
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Telephone:
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Email:
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Affiliation:
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North Denmark Regional Hospital |
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Name:
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Anne L Krarup, PhD |
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Address:
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Telephone:
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Email:
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Affiliation:
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North Denmark Regional Hospital |
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Key inclusion & exclusion criteria
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Inclusion Criteria:
- Colitis ulcerosa in remission (calciprotectin<200 and normal sigmoidoscopy)
- ROM IV criteria fullfilled
- Stable medical therapy
Exclusion Criteria:
- Intake of a low FODMAP diet within the past 6 weeks prior to baseline
- Atypical colitis ulcerosa primarily right sided disease and calciprotectin >50 unless
normal sigmoidoscopy
- If diarrhea: Clostridium difficile infection
- Lactose intolerance
- Systemisk or local treatment for CU other than 5-aminosalicylicacid or biological
therapy
- Antibiotics within 6 weeks
- Pregnancy
- Activity in UC
- Coeliac disease
- Abnormal transglutaminase
- Eating disorder
- Special diet preventing the low FODMAP diet
- Other GI disease or other disease explaining symptoms
- Medication intake explaining symptoms
- Not able to follow protocol
Age minimum:
18 Years
Age maximum:
70 Years
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: Low FODMAP
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Dietary Supplement: Standardized FODMAP
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Primary Outcome(s)
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Gastrointestinal symptoms
[Time Frame: Week 8]
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Secondary Outcome(s)
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Change in Quality of life
[Time Frame: Week 8]
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Pain diary
[Time Frame: Daily during the study]
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Secondary ID(s)
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RHN_ALK_01
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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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