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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02859675
Other study ID # BRONDEL Ass INRA 2011
Secondary ID
Status Completed
Phase
First received
Last updated
Start date October 7, 2013
Est. completion date May 3, 2021

Study information

Verified date February 2024
Source Centre Hospitalier Universitaire Dijon
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.


Recruitment information / eligibility

Status Completed
Enrollment 62
Est. completion date May 3, 2021
Est. primary completion date May 3, 2021
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Female
Age group 18 Years to 60 Years
Eligibility 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

Study Design


Intervention

Other:
triangular test
metabolic state, impedance measurement, potential flavours evoked by sucrose,
Biological:
blood sampling
sampling of 2 mL
Other:
Questionnaires
Stunkard, PrefQuest

Locations

Country Name City State
France Centre Hospitalier Universitaire Dijon

Sponsors (1)

Lead Sponsor Collaborator
Centre Hospitalier Universitaire Dijon

Country where clinical trial is conducted

France, 

Outcome

Type Measure Description Time frame Safety issue
Primary Modification of sweet taste the measurement of detection thresholds consists in presenting to the participants in order of increasing concentrations, series of forced-choice triangular tests through the study completion up to 10 years
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