Crohn's DiseaseSmell&CrohnNCT02859675
Olfactogustatory Perception, Eating Behaviour and Inflammation in Crohn's Disease
An observational study of Crohn's Disease and Olfactogustatory Perception, run by Centre Hospitalier Universitaire Dijon at 1 site in France.
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… Read more about this study
- Who is it for?
- Ages 18 to 60 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Crohn's Disease, Olfactogustatory Perception
- What is being tested?
- triangular test, blood sampling and Questionnaires
- How many people
- 62 participants
- Where
- 1 siteFrance
- Study dates
- 7 Oct 2013to 3 May 2021
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 60 years
- Women only
- Healthy volunteers accepted
- Adult
Study population: understanding of the mechanisms underlying anorexia in persons with Crohn's disease flare-ups
Who may be able to join
- 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.
- Adult person
- Without follow-up for a chronic pathology
- Having given its consent
Who cannot join
- 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,
Show all 16Show fewer
- 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:
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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.
- Conditions
- Crohn's Disease, Olfactogustatory Perception
- Being tested
- triangular test, blood sampling, Questionnaires
- Medical subject headings
- Crohn Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
triangular testOther
metabolic state, impedance measurement, potential flavours evoked by sucrose,
blood samplingBiological
sampling of 2 mL
QuestionnairesOther
Stunkard, PrefQuest
| Study group | Role | What they receive |
|---|---|---|
| Crohn and anti-TNF treatment | Tests at 3 or 4 weeks after the beginning of anti-TNF treatment Receives: Other: triangular test; Biological: blood sampling; Other: Questionnaires | |
| Crohn and without anti-TNF treatment | tests performed according to patient availability Receives: Other: triangular test; Biological: blood sampling; Other: Questionnaires | |
| Control | tests performed according to patient availability Receives: Other: triangular test; Biological: blood sampling; Other: Questionnaires |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: through the study completion up to 10 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Aug 2016 (estimated)
- Study start7 Oct 2013
- Primary completion3 May 2021
- Study completion3 May 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Crohn's DiseaseStudies of the same condition, open and under way.
- More trials run by Centre Hospitalier Universitaire DijonThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 62 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Universitaire Dijon
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02859675
- Sponsor's protocol ID
- BRONDEL Ass INRA 2011
- Acronym
- Smell&Crohn
- Status last verified
- Feb 2024
- First submitted
- 28 Jul 2016
- Last updated
- 22 Feb 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Olfactogustatory Perception, Eating Behaviour and Inflammation in Crohn's Disease
- ClinicalTrials.gov ID
- NCT02859675
- Acronym / sponsor ID
- Smell&Crohn / BRONDEL Ass INRA 2011
- Conditions
- Crohn's Disease, Olfactogustatory Perception
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 62 participants (actual)
- Lead sponsor
- Centre Hospitalier Universitaire DijonUniversity, hospital or other
- Study start
- 7 Oct 2013 (actual)
- Primary completion
- 3 May 2021 (actual)
- Study completion
- 3 May 2021 (actual)
- First posted
- 9 Aug 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Crohn and anti-TNF treatment | – | Other: triangular test, Biological: blood sampling, Other: QuestionnairesTests at 3 or 4 weeks after the beginning of anti-TNF treatment |
| Crohn and without anti-TNF treatment | – | Other: triangular test, Biological: blood sampling, Other: Questionnairestests performed according to patient availability |
| Control | – | Other: triangular test, Biological: blood sampling, Other: Questionnairestests performed according to patient availability |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- understanding of the mechanisms underlying anorexia in persons with Crohn's disease flare-ups
Key inclusion criteria (6 listed)
- 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.
- Adult person
- Without follow-up for a chronic pathology
Key exclusion criteria (16 listed)
- 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,
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| triangular testmetabolic state, impedance measurement, potential flavours evoked by sucrose, | Other | Control, Crohn and anti-TNF treatment, Crohn and without anti-TNF treatment |
| blood samplingsampling of 2 mL | Biological | Control, Crohn and anti-TNF treatment, Crohn and without anti-TNF treatment |
| QuestionnairesStunkard, PrefQuest | Other | Control, Crohn and anti-TNF treatment, Crohn and without anti-TNF treatment |
Primary outcome
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Feb 2024.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Crohn's Disease and Olfactogustatory Perception, run by Centre Hospitalier Universitaire Dijon at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 16 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 22 Feb 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Modification of sweet taste (time frame: through the study completion up to 10 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Feb 2024.