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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

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.

Condition or disease Intervention/treatment
Crohn's Disease Olfactogustatory Perception Other: triangular test Biological: blood sampling Other: Questionnaires

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Study Type : Observational
Estimated Enrollment : 75 participants
Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Olfactogustatory Perception, Eating Behaviour and Inflammation in Crohn's Disease
Actual Study Start Date : October 7, 2013
Estimated Primary Completion Date : July 2023
Estimated Study Completion Date : December 2023

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Crohn's Disease

Group/Cohort Intervention/treatment
Crohn and anti-TNF treatment
Tests at 3 or 4 weeks after the beginning of anti-TNF treatment
Other: triangular test
metabolic state, impedance measurement, potential flavours evoked by sucrose,

Biological: blood sampling
sampling of 2 mL

Other: Questionnaires
Stunkard, PrefQuest

Crohn and without anti-TNF treatment
tests performed according to patient availability
Other: triangular test
metabolic state, impedance measurement, potential flavours evoked by sucrose,

Biological: blood sampling
sampling of 2 mL

Other: Questionnaires
Stunkard, PrefQuest

Control
tests performed according to patient availability
Other: triangular test
metabolic state, impedance measurement, potential flavours evoked by sucrose,

Biological: blood sampling
sampling of 2 mL

Other: Questionnaires
Stunkard, PrefQuest




Primary Outcome Measures :
  1. 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



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 60 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
understanding of the mechanisms underlying anorexia in persons with Crohn's disease flare-ups
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02859675


Contacts
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Contact: Laurent BRONDEL 06.77.10.86.53 ext 33 laurent.brondel@u-bourgogne.fr

Locations
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France
Centre Hospitalier Universitaire Recruiting
Dijon, France, 21079
Contact: Laurent BRONDEL    06 77 10 86 53 ext 33    laurent.brondel@u-bourgogne.fr   
Sponsors and Collaborators
Centre Hospitalier Universitaire Dijon

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Responsible Party: Centre Hospitalier Universitaire Dijon
ClinicalTrials.gov Identifier: NCT02859675     History of Changes
Other Study ID Numbers: BRONDEL Ass INRA 2011
First Posted: August 9, 2016    Key Record Dates
Last Update Posted: August 15, 2019
Last Verified: August 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
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Inflammation
Crohn Disease
Pathologic Processes
Inflammatory Bowel Diseases
Gastroenteritis
Gastrointestinal Diseases
Digestive System Diseases
Intestinal Diseases