Crohn's DiseaseNCT03871634
Assessment of Nutritional Status of Patients With Crohn's Disease
An observational study of Crohn's Disease and Malnutrition, run by Harokopio University at 1 site in Greece.
Trial summary
Good nutritional status of patients with Crohn's disease (CD) is associated with better outcome of the disease and better health-related quality of life. The prevalence of malnutrition in patients with Crohn's disease varies and is higher in patients with active disease. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Crohn's Disease, Malnutrition, Overweight and Obesity
- How many people
- 250 participants
- Where
- 1 siteGreece
- Study dates
- 18 Dec 2018to 31 Aug 2023
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: 250 adult patients with active Crohn's Disease or in remission phase
Who may be able to join
- Adults with Crohn's Disease either with active disease or in remission phase.
Who cannot join
- 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 locations and contacts
1 site in 1 country.
About this study
Good nutritional status of patients with Crohn's disease (CD) is associated with better outcome of the disease and better health-related quality of life. 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 250 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 as well as overweight and obesity. Finally, the effect of the nutritional status on the course of the disease will be investigated.
Read the 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.
- Medical subject headings
- Crohn Disease, Malnutrition, Overweight, Obesity, Sarcopenia
What is being measured
The primary outcome is the main question the study is designed to answer.
Prevalence of malnutrition phenotypes
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.
Measured: Baseline
Secondary outcomes (1)
Validity test of available tools
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.
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Mar 2019
- Study start18 Dec 2018
- Primary completion31 Dec 2020
- Study completion31 Aug 2023
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.
- 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 250 participants (actual)
Sponsor and investigators
- Lead sponsor
- Harokopio University
- Sponsor type
- University, hospital or other
- Collaborators
- Evangelismos Hospital, Sotiria General Hospital, General Hospital of Nikaia "Saint Panteleimon"
- Responsible party
- Principal investigator, Meropi Kontogianni, Harokopio University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03871634
- Sponsor's protocol ID
- 122
- Status last verified
- Sep 2023
- First submitted
- 9 Mar 2019
- Last updated
- 22 Sep 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Sep 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessment of Nutritional Status of Patients With Crohn's Disease
- ClinicalTrials.gov ID
- NCT03871634
- Acronym / sponsor ID
- 122
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 250 participants (actual)
- Lead sponsor
- Harokopio UniversityUniversity, hospital or other
- Collaborators
- Evangelismos Hospital, Sotiria General Hospital, General Hospital of Nikaia "Saint Panteleimon"
- Study start
- 18 Dec 2018 (actual)
- Primary completion
- 31 Dec 2020 (actual)
- Study completion
- 31 Aug 2023 (actual)
- First posted
- 12 Mar 2019 (actual)
- 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.
Good nutritional status of patients with Crohn's disease (CD) is associated with better outcome of the disease and better health-related quality of life. 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 250 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 as well as overweight and obesity. Finally, the effect of the nutritional status on the course of the disease will be investigated.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- 250 adult patients with active Crohn's Disease or in remission phase
Key inclusion criteria (1 listed)
- Adults with Crohn's Disease either with active disease or in remission phase.
Key exclusion criteria (7 listed)
- Hospitalized patients
- Patients with Crohn's disease <6 months
- Patients with cancer
- Patients with heart insufficiency
- Patients with renal insufficiency
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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.
1 secondary outcome
Validity test of available tools
Time frame: Baseline
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 Sep 2023.
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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 Malnutrition, run by Harokopio University at 1 site in Greece.
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 1 inclusion and 7 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 Sep 2023. 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 Greece. 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?
Prevalence of malnutrition phenotypes (time frame: Baseline). 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 Sep 2023.