Assessment of Nutritional Status of Patients With Crohn's Disease

Study Purpose

Good nutritional status of patients with Crohn's disease (CD) is associated with better outcome of the disease. The prevalence of malnutrition in patients with Crohn's disease varies and is higher in patients with active disease. Available studies in the literature have assessed the nutritional status of patients with Crohn's disease. However, sample size of available studies is small and highly heterogeneous, and most patients are hospitalized with active disease. The aim of the present study is a thorough assessment of nutritional status of 220 patients either with active Crohn's disease or in remission of the disease using multiple widely available tools and methods, in order to assess their accuracy and estimate the prevalence of multiple malnutrition phenotypes such as undernutrition, sarcopenia, sarcopenic obesity and cachexia. Finally, the effect of the nutritional status on the course of the disease will be investigated.

Recruitment Criteria

Accepts Healthy Volunteers

Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms

No
Study Type

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.

Observational
Eligible Ages 18 Years and Over
Gender All
More Inclusion & Exclusion Criteria

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.

Trial Details

Trial ID:

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.

NCT03871634
Phase

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.

Lead Sponsor

The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.

Harokopio University
Principal Investigator

The person who is responsible for the scientific and technical direction of the entire clinical study.

N/A
Principal Investigator Affiliation N/A
Agency Class

Category of organization(s) involved as sponsor (and collaborator) supporting the trial.

OtherOtherOtherOther
Overall Status Recruiting
Countries Greece
Conditions

The disease, disorder, syndrome, illness, or injury that is being studied.

Crohn Disease, Malnutrition
Additional Details

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 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 and meal patterns 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 ESPEN's (European Society of Parenteral and Enteral Nutrition) recent malnutrition diagnostic criteria. The full assessment will be repeated only for patients who will change medications. Three months, six months, nine 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.

Contact a Trial Team

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International Sites

Harokopio University, Athens, Kallithea, Greece

Status

Recruiting

Address

Harokopio University

Athens, Kallithea, 17671

Site Contact

Meropi D Kontogianni

mkont@hua.gr

00302109549359

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