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OpenTrials
Completed

NCT Number: NCT02859675

Olfactogustatory Perception, Eating Behaviour and Inflammation in Crohn's Disease

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.

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Key information

Age range

18 year–60 year

Sex eligibility

Female

Study type

Observational

Primary location

Centre Hospitalier Universitaire

Dijon, 21079, France

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

triangular test

Other

metabolic state, impedance measurement, potential flavours evoked by sucrose,

Blood sampling

Biological

sampling of 2 mL

questionnaires

Other

Stunkard, PrefQuest

Primary outcomes

  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

Sponsors and collaborators

Lead sponsor

Centre Hospitalier Universitaire Dijon

Other

Registry information

Acronym: Smell&Crohn

Important dates

Study start
2013
Primary completion
2021
Study completion
2021
First posted
Aug 9, 2016
Registry last updated
Feb 22, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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