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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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4 March 2024 |
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Main ID: |
NCT02859675 |
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Date of registration:
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28/07/2016 |
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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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Olfactogustatory Perception, Eating Behaviour and Inflammation in Crohn's Disease
Smell&Crohn |
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Scientific title:
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Olfactogustatory Perception, Eating Behaviour and Inflammation in Crohn's Disease |
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Date of first enrolment:
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October 7, 2013 |
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Target sample size:
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62 |
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Recruitment status: |
Completed |
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URL:
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https://clinicaltrials.gov/ct2/show/NCT02859675 |
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Study type:
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Observational |
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Study design:
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Phase:
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Countries of recruitment
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France
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Key inclusion & exclusion criteria
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For patients :
Inclusion Criteria:
- Age between 18 and 60 years,
- Diagnosis of Crohn's disease according to clinical, endoscopic, histological,
radiological and biochemical criteria as defined by the European Consensus Conference,
- Men or women who have provided consent and willing to cooperate.
Exclusion Criteria:
- Chronic inflammatory intestinal disease (CIID) other than Crohn's disease:
haemorrhagic rectocolitis, undetermined colitis, microscopic colitis.
- Intercurrent disease (diabetes and metabolic disease, liver cirrhosis, progressive
cancer, acute or chronic infection, Human Immunodeficiency Virus HIV),
- Organ failure (respiratory, heart, or renal failure, neurological disorders),
- Intolerance to gluten,
- Treatments (other than those used for Crohn's disease) able to interfere with food
intake,
- Aversion to foods consumed or smelled,
- Poor understanding of cognitive tasks required.
- Crohn's disease complicated by an abscess or infectious complication
- Acute Crohn's disease defined by a CDAI score > 150
For Controls:
Inclusion Criteria:
- Adult person
- Without follow-up for a chronic pathology
- Having given its consent
Exclusion Criteria:
- Protected adult
- Person not affiliated to a social security system
- Pregnant or breastfeeding woman
- Active smoker
- No one who does not speak French
- Taking treatment that interferes with taste or acts on the central nervous system
Age minimum:
18 Years
Age maximum:
60 Years
Gender:
Female
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Health Condition(s) or Problem(s) studied
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Crohn's Disease
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Olfactogustatory Perception
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Intervention(s)
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Other: triangular test
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Other: Questionnaires
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Biological: blood sampling
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Primary Outcome(s)
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Modification of sweet taste
[Time Frame: through the study completion up to 10 years]
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Secondary ID(s)
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BRONDEL Ass INRA 2011
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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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