Clinical Trials Logo

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
See also
  Status Clinical Trial Phase
Active, not recruiting NCT03815851 - Relationship Between Prophylactic Drainage and Postoperative Complications (PPOI) in Crohn's Patients After Surgery N/A
Not yet recruiting NCT06100289 - A Study of Vedolizumab in Children and Teenagers With Ulcerative Colitis or Crohn's Disease Phase 3
Completed NCT02883452 - A Phase I Study to Evaluate Pharmacokinetics, Efficacy and Safety of CT-P13 Subcutaneous in Patients With Active Crohn's Disease and Ulcerative Colitis Phase 1
Recruiting NCT04777656 - Use of Crohn's Disease Exclusion Diet on Top of Standard Therapy Versus Standard Therapy Alone in Unstable Pediatric Crohn's Disease Patients. Phase 3
Terminated NCT03017014 - A Study to Assess Safety and Effectiveness of Adalimumab for Treating Children and Adolescents With Crohn's Disease in Real Life Conditions
Recruiting NCT06053424 - Positron Emission Tomography Study of Changes in [11C]AZ14132516 Uptake Following Administration of AZD7798 to Healthy Participants and Patients With Crohn's Disease Phase 1
Recruiting NCT05428345 - A Study of Vedolizumab SC Given to Adults With Moderate to Severe Ulcerative Colitis or Crohn's Disease in South Korea
Completed NCT02508012 - Medico-economic Evaluation of the Therapeutic Drug Monitoring of Anti-TNF-α Agents in Inflammatory Bowel Diseases N/A
Not yet recruiting NCT02858557 - The Effect of Diet on Microbial Profile and Disease Outcomes in Patients With Inflammatory Bowel Diseases N/A
Terminated NCT02882841 - MOlecular BIomarkers and Adherent and Invasive Escherichia Coli (AIEC) Detection Study In Crohn's Disease Patients N/A
Terminated NCT02417974 - Prevention of Recurrence of Crohn's Disease by Fecal Microbiota Therapy (FMT) Phase 2
Completed NCT02542917 - Home Versus Postal Testing for Faecal Calprotectin: a Feasibility Study
Completed NCT03010787 - A First Time in Human Study in Healthy Volunteers and Patients Phase 1
Active, not recruiting NCT02316678 - Patient Attitudes and Preferences for Outcomes of Inflammatory Bowel Disease Therapeutics N/A
Completed NCT02265588 - Healthy Approach to Physical and Psychological Problems in Youngsters With IBD (HAPPY-IBD). N/A
Completed NCT02197780 - Head-to-head Comparison of Two Fecal Biomarkers to Screen Children for IBD N/A
Completed NCT02154425 - A Multicenter, Postmarketing Study Evaluating the Concentration of Cimzia® in Mature Breast Milk of Lactating Mothers Phase 1
Completed NCT02193048 - Prospective Evaluation of a Scoring System in Patients Newly Diagnosed With Crohn's Disease
Recruiting NCT02395354 - Comparative Prospective Multicenter Randomized Study of Endoscopic Treatment of Stenosis in Crohn´s Disease N/A
Completed NCT01958827 - A Study of Adalimumab After Dose Escalation in Japanese Subjects With Crohn's Disease Phase 3