- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03871634
Assessment of Nutritional Status of Patients With Crohn's Disease
Study Overview
Status
Detailed Description
The study sample will comprise of 250 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, MedGraphics Cardiorespiratory Diagnostics).
- Anthropometry: Weight, height, waist and mid-arm circumference, and triceps skinfold will be measured. Body mass index, mid-arm muscle circumference and area will be estimated using standard equations.
- 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. Data will be analyzed to estimate energy, macro- and micronutrients intake (Nutritionist Pro software, 2.2 version). Food group intake, meal patterns and MedDietScore will also be evaluated.
- 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).
In addition, patients' nutritional risk or nutritional status will be assessed through several previously validated tools like the Subjective Global Assessment, the Nutrition Risk Score 2002, the Malnutrition Universal Screening Tool, the efficacy of which will be tested in the present study. Patients will be also categorized according to GLIM criteria for the diagnosis of malnutrition.
Six months and twelve months after the baseline assessment of the study samples, data will be collected regarding the hospitalizations, disease relapse, duration of remission and complications of all the patients.
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
-
-
Kallithea
-
Athens, Kallithea, Greece, 17671
- Harokopio University
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
Inclusion Criteria:
- Adults with Crohn's Disease either with active disease or in remission phase.
Exclusion Criteria:
- 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.
Study Plan
How is the study designed?
Design Details
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Prevalence of malnutrition phenotypes
Time Frame: Baseline
|
Prevalence of different malnutrition phenotypes (e.g.
undernutrition, sarcopenia, sarcopenic obesity), in crohn disease patients either with active disease or in remission, by implementing a thorough nutritional assessment.
|
Baseline
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Validity test of available tools
Time Frame: Baseline
|
Test the sensitivity, specificity, positive and negative prognostic values of already available tools for nutritional screening or assessment against a combined index as the reference tool.
If no tool is estimated as valid, a new combination of nutritional, biochemical and/or clinical parameters will be synthesized and its validity as a new screening or assessment tool will be assessed for the detection of cirrhotic patients at risk of malnutrition or already malnourished.
|
Baseline
|
Collaborators and Investigators
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Digestive System Diseases
- Nervous System Diseases
- Neurologic Manifestations
- Gastrointestinal Diseases
- Overnutrition
- Nutrition Disorders
- Body Weight
- Gastroenteritis
- Intestinal Diseases
- Neuromuscular Manifestations
- Pathological Conditions, Anatomical
- Muscular Atrophy
- Atrophy
- Inflammatory Bowel Diseases
- Obesity
- Overweight
- Sarcopenia
- Crohn Disease
- Malnutrition
Other Study ID Numbers
- 122 (Council for Stem Cell Sciences and Technologies)
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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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