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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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20 June 2016 |
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Main ID: |
NCT02426567 |
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Date of registration:
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17/04/2015 |
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Prospective Registration:
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No |
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Primary sponsor: |
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Public title:
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The Impact of "Crohn's Disease-TReatment-with-EATing" Diet and Exclusive Enteral Nutrition on Healthy Gut Bacteria
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Scientific title:
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An Exploratory Study on the Impact of a Food-based Restrictive Diet (Crohn's Disease-TReatment-with EATing/CD-TREAT Diet) and Liquid Exclusive Enteral Nutrition (EEN) on Healthy Gut Microbiota Composition and Metabolic Activity |
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Date of first enrolment:
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November 2014 |
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Target sample size:
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28 |
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Recruitment status: |
Completed |
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URL:
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https://clinicaltrials.gov/show/NCT02426567 |
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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: Crossover Assignment, Masking: Open Label, Primary Purpose: Basic Science
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Phase:
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N/A
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Countries of recruitment
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United Kingdom
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Contacts
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Name:
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Konstantinos Gerasimidis, BSc MSc 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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University of Glasgow |
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Key inclusion & exclusion criteria
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Inclusion Criteria:
1. Healthy adult people
2. Normal weight (Body Mass Index: 18-25kg/m^2)
3. Stable weight the past month
Exclusion Criteria:
1. Acute or chronic illness (defined as illness which requires regular visits to health
services)
2. Positive or negative energy balance (recent weight gain or loss, ±2 Kg the past
month)
3. History of gut surgery
4. Use of antibiotics or steroids the last 3 months
Age minimum:
18 Years
Age maximum:
N/A
Gender:
Both
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Health Condition(s) or Problem(s) studied
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Dietary Modification
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Crohn's Disease
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Intervention(s)
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Other: Crohn's Disease TReatment-with-EATing diet (CD-TREAT diet)
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Other: Exclusive Enteral Nutrition (EEN)
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Primary Outcome(s)
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Gut Bacterial Composition
[Time Frame: 12 months]
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Gut Bacterial Metabolites
[Time Frame: 12 months]
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Secondary Outcome(s)
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Dietary Intake
[Time Frame: 12 months]
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Secondary ID(s)
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200130161
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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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