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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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6 June 2022 |
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Main ID: |
NCT02930564 |
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Date of registration:
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09/10/2016 |
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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 Challenge Study: A Dietary Personalization Protocol for Patients With Crohn's Disease and Deep Remission
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Scientific title:
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The Challenge Study: A Dietary Personalization Protocol for Patients With Crohn's Disease and Deep Remission |
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Date of first enrolment:
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January 2017 |
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Target sample size:
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10 |
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Recruitment status: |
Terminated |
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URL:
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https://clinicaltrials.gov/show/NCT02930564 |
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Study type:
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Interventional |
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Study design:
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Allocation: N/A. Intervention model: Single Group 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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Israel
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Contacts
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Name:
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Arie Levine, MD |
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Address:
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Telephone:
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Email:
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Affiliation:
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Pediatric Gastroenterology and Nutrition Unit, The E. Wolfson MC, Tel-Aviv University, Holon, Israel |
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Key inclusion & exclusion criteria
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Inclusion Criteria:
1. Established diagnosis of Crohn's disease.
2. Patients in sustained remission with PCDAI 0 > 6 months
3. Ages 8-20
4. Normal CRP (CRP<0.5), normal Calprotectin (<100)
5. Patients with uncomplicated disease
6. Signed informed consent
Exclusion Criteria:
1. Patients with active disease (PCDAI >10)
2. Pregnancy
3. Patients with complicated disease (B2, B3)
4. Patients with recent onset use of an immunomodulator <12 weeks, or dose change in past
12 weeks.
5. Patients with current use of biologics.
6. Elevated CRP or Calprotetcin>100 at screening.
Age minimum:
8 Years
Age maximum:
20 Years
Gender:
All
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Health Condition(s) or Problem(s) studied
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Crohn's Disease
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Intervention(s)
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Other: CDED + milk fat and gluten
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Primary Outcome(s)
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number of patients with calprotetctin elevation
[Time Frame: day 14 or 21]
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Secondary ID(s)
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0186-16-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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