Accepts Healthy Volunteers
Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms
An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.
An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes.
Searching Both is inclusive of interventional and observational studies.
|Eligible Ages||18 Years and Over|
- - Adults with Crohn's Disease either with active disease or in remission phase.
- - Hospitalized patients - Patients with Crohn's disease <6 months - Patients with cancer - Patients with heart insufficiency - Patients with renal insufficiency - Patients with short bowel syndrome (SBS) - Patients with parenteral nutrition.
This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.
Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans.
Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data.
Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs.
Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.
The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.
The person who is responsible for the scientific and technical direction of the entire clinical study.
|Principal Investigator Affiliation||N/A|
Category of organization(s) involved as sponsor (and collaborator) supporting the trial.
The disease, disorder, syndrome, illness, or injury that is being studied.
|Crohn Disease, Malnutrition|
The study sample will comprise of 220 adults with proven Crohn's disease, either with active disease or in remission phase. A detailed medical and nutritional assessment will be implemented at baseline. Data regarding the hospitalizations, disease relapse, duration of remission and complications of all the patients will be collected one year after the baseline assessment. More specifically regarding the detailed assessment, firstly, gastroenterologists of the research team will complete a full medical record regarding the localization of the disease, activity of disease (active or remission), complications, comorbidities and medication. The activity of Crohn's disease will be assessed using the Harvey-Bradshaw Index (HBI). Blood will be collected for all patients with Crohn's Disease. Furthermore, in the Laboratory of Clinical Nutrition & Dietetics at Harokopio University, patients will participate in the following procedures:
- - Indirect calorimetry: Resting Energy Expenditure (REE) measurement will be performed (Ultima Series, Cosmed).
- - Anthropometry: Weight, height, waist and mid-arm circumference, and triceps skinfold will be measured.
- - Body composition analysis and bone density measurement: Total body Dual-energy X-Ray Absorptiometry (DXA) and Spine (Lunar DPX-MD, Madison, WI, USA) will be performed.
- - Muscle strength and performance status: Handgrip strength measurement based on certain protocol and the "Short Physical Performance Battery" (SPPB) tool will be implemented.
- - Dietary intake evaluation: A Food-Frequency Questionnaire (FFQ) and two non-consecutive 24h recalls (one weekday and one weekend day) will be recorded.
- - Physical activity assessment: Patients' physical activity levels will be assessed using the "Harokopio Physical Activity Questionnaire".
- - Fatigue and Quality of Life Assessment: Assessment of fatigue will be performed with "Fatigue Severity Scale" (FSS), when assessment of quality of life with be performed with "Food Related Quality of Life" (FR-QoL) and "Short Inflammatory Bowel Disease Questionnaire" (SIBDQ).
Contact a Trial Team
If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.