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

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

      • 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

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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