- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02859675
Olfactogustatory Perception, Eating Behaviour and Inflammation in Crohn's Disease (Smell&Crohn)
February 21, 2024 updated by: Centre Hospitalier Universitaire Dijon
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Observational
Enrollment (Actual)
62
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
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Dijon, France, 21079
- Centre Hospitalier Universitaire
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 60 years (Adult)
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
Description
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 Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
|
Crohn and anti-TNF treatment
Tests at 3 or 4 weeks after the beginning of anti-TNF treatment
|
metabolic state, impedance measurement, potential flavours evoked by sucrose,
sampling of 2 mL
Stunkard, PrefQuest
|
|
Crohn and without anti-TNF treatment
tests performed according to patient availability
|
metabolic state, impedance measurement, potential flavours evoked by sucrose,
sampling of 2 mL
Stunkard, PrefQuest
|
|
Control
tests performed according to patient availability
|
metabolic state, impedance measurement, potential flavours evoked by sucrose,
sampling of 2 mL
Stunkard, PrefQuest
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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
|
through the study completion up to 10 years
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
October 7, 2013
Primary Completion (Actual)
May 3, 2021
Study Completion (Actual)
May 3, 2021
Study Registration Dates
First Submitted
July 28, 2016
First Submitted That Met QC Criteria
August 4, 2016
First Posted (Estimated)
August 9, 2016
Study Record Updates
Last Update Posted (Estimated)
February 22, 2024
Last Update Submitted That Met QC Criteria
February 21, 2024
Last Verified
February 1, 2024
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- BRONDEL Ass INRA 2011
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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