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Olfactogustatory Perception, Eating Behaviour and Inflammation in Crohn's Disease (Smell&Crohn)

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ClinicalTrials.gov Identifier: NCT02859675
Recruitment Status : Recruiting
First Posted : August 9, 2016
Last Update Posted : August 15, 2019
Sponsor:
Information provided by (Responsible Party):
Centre Hospitalier Universitaire Dijon

Tracking Information
First Submitted Date July 28, 2016
First Posted Date August 9, 2016
Last Update Posted Date August 15, 2019
Actual Study Start Date October 7, 2013
Estimated Primary Completion Date July 2023   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: August 13, 2019)
Modification of sweet taste [ Time Frame: through the study completion up to 10 years ]
the measurement of detection thresholds consists in presenting to the participants in order of increasing concentrations, series of forced-choice triangular tests
Original Primary Outcome Measures
 (submitted: August 4, 2016)
  • Modification of sweet taste [ Time Frame: through the study completion up to 4 years ]
    the measurement of detection thresholds consists in presenting to the participants in order of increasing concentrations, series of forced-choice triangular tests
  • Modification of salty taste [ Time Frame: through the study completion up to 4 years ]
    the measurement of detection thresholds consists in presenting to the participants in order of increasing concentrations, series of forced-choice triangular tests
  • Modification of sour taste [ Time Frame: through the study completion up to 4 years ]
    the measurement of detection thresholds consists in presenting to the participants in order of increasing concentrations, series of forced-choice triangular tests
  • Modification of bitter taste [ Time Frame: through the study completion up to 4 years ]
    the measurement of detection thresholds consists in presenting to the participants in order of increasing concentrations, series of forced-choice triangular tests
  • Modification of umami taste [ Time Frame: through the study completion up to 4 years ]
    the measurement of detection thresholds consists in presenting to the participants in order of increasing concentrations, series of forced-choice triangular tests
Change History
Current Secondary Outcome Measures Not Provided
Original Secondary Outcome Measures Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Olfactogustatory Perception, Eating Behaviour and Inflammation in Crohn's Disease
Official Title Olfactogustatory Perception, Eating Behaviour and Inflammation in Crohn's Disease
Brief Summary This study will improve our understanding of the mechanisms underlying anorexia in persons with Crohn's disease flare-ups. The practical spin-off from this research is potentially very important for the management of nutritional disorders associated with the disease by guiding diets towards foods that correspond to patients' preferences and/or to modified tastes. In addition, the results could lead to the identification of sensory markers that herald an inflammatory flare-up of the disease.
Detailed Description Not Provided
Study Type Observational
Study Design Observational Model: Case-Only
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Non-Probability Sample
Study Population understanding of the mechanisms underlying anorexia in persons with Crohn's disease flare-ups
Condition
  • Crohn's Disease
  • Olfactogustatory Perception
Intervention
  • Other: triangular test
    metabolic state, impedance measurement, potential flavours evoked by sucrose,
  • Biological: blood sampling
    sampling of 2 mL
  • Other: Questionnaires
    Stunkard, PrefQuest
Study Groups/Cohorts
  • Crohn and anti-TNF treatment
    Tests at 3 or 4 weeks after the beginning of anti-TNF treatment
    Interventions:
    • Other: triangular test
    • Biological: blood sampling
    • Other: Questionnaires
  • Crohn and without anti-TNF treatment
    tests performed according to patient availability
    Interventions:
    • Other: triangular test
    • Biological: blood sampling
    • Other: Questionnaires
  • Control
    tests performed according to patient availability
    Interventions:
    • Other: triangular test
    • Biological: blood sampling
    • Other: Questionnaires
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Recruiting
Estimated Enrollment
 (submitted: August 13, 2019)
75
Original Actual Enrollment
 (submitted: August 4, 2016)
1
Estimated Study Completion Date December 2023
Estimated Primary Completion Date July 2023   (Final data collection date for primary outcome measure)
Eligibility Criteria

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
Sex/Gender
Sexes Eligible for Study: Female
Ages 18 Years to 60 Years   (Adult)
Accepts Healthy Volunteers Yes
Contacts
Contact: Laurent BRONDEL 06.77.10.86.53 ext 33 laurent.brondel@u-bourgogne.fr
Listed Location Countries France
Removed Location Countries  
 
Administrative Information
NCT Number NCT02859675
Other Study ID Numbers BRONDEL Ass INRA 2011
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement Not Provided
Responsible Party Centre Hospitalier Universitaire Dijon
Study Sponsor Centre Hospitalier Universitaire Dijon
Collaborators Not Provided
Investigators Not Provided
PRS Account Centre Hospitalier Universitaire Dijon
Verification Date August 2019