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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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22 August 2016 |
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Main ID: |
NCT02217722 |
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Date of registration:
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20/07/2014 |
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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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Use of the Ulcerative Colitis Diet for Induction of Remission
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Scientific title:
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An Open Label Non Randomized Pilot Study: Use of the Ulcerative Colitis Diet for Induction of Remission. |
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Date of first enrolment:
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October 2014 |
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Target sample size:
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9 |
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Recruitment status: |
Terminated |
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URL:
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https://clinicaltrials.gov/show/NCT02217722 |
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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: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
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Phase:
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N/A
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Countries of recruitment
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Israel
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Key inclusion & exclusion criteria
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Inclusion Criteria:
- Informed consent
- Established diagnosis of UC disease.
- Age: 5 - 18 years ( inclusive)
- Mild to moderate active disease, 10 = PUCAI =45.
- Stable medication (IMM/ 5ASA) use for the past 6 weeks.
- For patients who received antibiotic treatment: age 10-18 (inclusive).
Exclusion Criteria:
- Any proven infection such as positive stool culture, parasite or C.difficile.
- Use of Antibiotics
- Use of steroids in the previous two weeks only
- Patients that are refractory to full dose steroids ( 1 mg/kg/day)
- Past acute severe UC.
- Current Extra intestinal manifestation of UC.
- Pregnancy.
A subset of patients who are on steroids and relapse during steroids treatment =0.5 mg/kg
with mild to moderate disease activity will act as a second subset for this exploratory
study.
Age minimum:
5 Years
Age maximum:
18 Years
Gender:
Both
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Health Condition(s) or Problem(s) studied
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Ulcerative Colitis (UC)
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Intervention(s)
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Drug: Antibiotic cocktail
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Other: Ulcerative Colitis Diet
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Primary Outcome(s)
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Remission rate, defined as a PUCAI less than 10 at week 6.
[Time Frame: week 6]
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Secondary Outcome(s)
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Change in mean Calprotectin week 6
[Time Frame: week 6]
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Change in Mean PUCAI week 6.
[Time Frame: week 6]
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Secondary ID(s)
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0096-14-WOMC
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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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