Intestinal FailureNCT07714499
Resting Energy Expenditure by Gastrointestinal Functional Status
A study testing Protocol-Defined Metabolic and Body Composition Assessment in people with Intestinal Failure and Short Bowel Syndrome, run by Institute of Oncology Ljubljana at 1 site in Slovenia.
Trial summary
This prospective, comparative interventional study will evaluate resting energy expenditure in adults with different gastrointestinal functional status. A total of 92 participants aged 18 to 65 years will be included: 30 healthy adults with normal gastrointestinal function and 62 patients with clinically confirmed… Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Intestinal Failure, Short Bowel Syndrome
- What is being tested?
- Protocol-Defined Metabolic and Body Composition Assessment
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 92 participants
- Where
- 1 siteSlovenia
- Study dates
- 1 Oct 2025to 1 Oct 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Group A - Healthy Controls:
- Age 18 to 65 years
- No diagnosed chronic diseases
- No hospitalization within the previous 30 days
- No acute illness within the previous 14 days
- Group B - Participants With Intestinal Failure:
Show all 9Show fewer
- Age 18 to 65 years
- Diagnostically confirmed intestinal failure
- Stable clinical condition
Who cannot join
- Uncontrolled hyperthyroidism or hypothyroidism
- Diabetes mellitus with poor glycemic control
- Adrenal gland disease
- Active inflammatory bowel disease, including Crohn's disease or ulcerative colitis
- Celiac disease
- Chronic pancreatitis
Show all 24Show fewer
- Active gastric or esophageal disease
- Irritable bowel syndrome with significant symptoms
- History of major abdominal surgery that permanently affects gastrointestinal function, except in participants with intestinal failure when this forms part of the condition under study
- Heart failure
- Active ischemic heart disease or recent myocardial infarction
- Chronic obstructive pulmonary disease
- Respiratory failure or need for long-term oxygen therapy
- Progressive neurodegenerative disease
- Dementia impairing the ability to participate
- Severe stroke with significant functional impairment
- Active tuberculosis
- HIV/AIDS with clinically significant immunosuppression
- Active systemic autoimmune disease
- Active malignant disease
- Advanced liver cirrhosis
- Chronic kidney disease
- Treatment with hemodialysis or peritoneal dialysis
- Pregnancy or breastfeeding
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Slovenia1 site, 1 recruiting
- Recruiting
Institute of Oncology Ljubljana
Ljubljana, 1000
Klemen Salmič, MSc, +386 1 587 9526, kschara@onko-i.si
About this study
Official title: Comparison of Resting Energy Expenditure According to Gastrointestinal Functional Status
This prospective, comparative interventional study will evaluate resting energy expenditure in adults with different gastrointestinal functional status. A total of 92 participants aged 18 to 65 years will be included: 30 healthy adults with normal gastrointestinal function and 62 patients with clinically confirmed intestinal failure. The intestinal failure group will include patients with short bowel syndrome and patients with other causes of intestinal failure.
Participants will be assigned to one of two protocol-defined groups according to their gastrointestinal functional status. Each participant will attend one study visit lasting approximately 90 to 120 minutes. The research procedures will include measurement of resting energy expenditure by indirect calorimetry after an overnight fast, assessment of body composition by dual-energy X-ray absorptiometry and bioelectrical impedance analysis, and blood sampling for inflammatory markers.
The primary objective is to compare resting energy expenditure between healthy participants and patients with intestinal failure and to determine whether resting energy expenditure differs according to the underlying cause of intestinal failure. Secondary objectives are to evaluate the associations between resting energy expenditure, lean body mass, fat mass, phase angle, and inflammatory markers. The results may contribute to more individualized nutritional management of patients with intestinal failure.
Read the detailed description
Intestinal failure is a condition in which the gastrointestinal tract is unable to provide adequate digestion and absorption of nutrients, electrolytes, and fluids. Patients may therefore require partial or complete parenteral nutrition. Their resting energy expenditure may be affected by the underlying cause of intestinal failure, changes in body composition, nutritional and metabolic status, and systemic inflammation. Accurate assessment of energy requirements is important for planning individualized nutritional support.
This is a prospective, comparative interventional study with two non-randomized, protocol-defined groups. Group A will include 30 healthy adults with normal gastrointestinal function. Group B will include 62 clinically stable patients with confirmed intestinal failure. Within Group B, approximately 38 participants will have short bowel syndrome and 24 will have other causes of type II or type III intestinal failure, including chronic intestinal dysmotility or extensive disease of the small intestinal mucosa.
The study intervention consists of metabolic, body-composition, and laboratory assessments performed according to a standardized research protocol. Each participant will complete the study during one visit at the Institute of Oncology Ljubljana. The visit will last approximately 90 to 120 minutes. Resting energy expenditure will be measured in the morning, after fasting, in a thermoneutral environment using indirect calorimetry. The indirect calorimetry measurement will last approximately 30 minutes and will determine oxygen consumption and carbon dioxide production.
Body composition will be assessed using dual-energy X-ray absorptiometry to measure lean body mass, fat mass, and bone mineral density. Bioelectrical impedance analysis will also be performed to determine phase angle as an indicator of cellular integrity and function. A blood sample will be collected to assess inflammatory markers, including C-reactive protein and calculated neutrophil-to-lymphocyte, platelet-to-lymphocyte, and lymphocyte-to-monocyte ratios.
Resting energy expenditure will be evaluated as an absolute value in kilocalories per day and in standardized forms, including adjustment for lean body mass, age, and sex. The primary analyses will compare resting energy expenditure between healthy participants and patients with intestinal failure and between patients with short bowel syndrome and patients with other causes of intestinal failure.
Secondary analyses will examine the associations between resting energy expenditure and body-composition parameters, phase angle, and inflammatory markers. The study is intended to improve understanding of metabolic requirements in intestinal failure and to support the development of more individualized nutritional recommendations for these patients.
- Conditions
- Intestinal Failure, Short Bowel Syndrome
- Being tested
- Protocol-Defined Metabolic and Body Composition Assessment
- Keywords
- Resting Energy Expenditure, Indirect Calorimetry, Body Composition, Dual-Energy X-Ray Absorptiometry
- Medical subject headings
- Intestinal Failure, Short Bowel Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Protocol-Defined Metabolic and Body Composition AssessmentDiagnostic test
Participants undergo a standardized research assessment during one study visit. Resting energy expenditure is measured by indirect calorimetry after fasting. Body composition is assessed by dual-energy X-ray absorptiometry and bioelectrical impedance analysis. Blood samples are collected for the assessment of inflammatory markers. These assessments are performed outside routine clinical care according to the study protocol.
| Study group | Role | What they receive |
|---|---|---|
| Healthy Controls | Active comparator | Adults with normal gastrointestinal function who serve as the comparison group. Participants undergo the protocol-defined metabolic, body-composition, and laboratory assessments during a single study visit, including indirect calorimetry after fasting, dual-energy X-ray absorptiometry, bioelectrical impedance analysis, and blood sampling for inflammatory markers. Receives: Diagnostic Test: Protocol-Defined Metabolic and Body Composition Assessment |
| Participants With Intestinal Failure | Experimental | Adults with clinically confirmed intestinal failure, including participants with short bowel syndrome and participants with other causes of intestinal failure. Participants undergo the protocol-defined metabolic, body-composition, and laboratory assessments during a single study visit, including indirect calorimetry after fasting, dual-energy X-ray absorptiometry, bioelectrical impedance analysis, and blood sampling for inflammatory markers. Receives: Diagnostic Test: Protocol-Defined Metabolic and Body Composition Assessment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Resting Energy Expenditure Measured by Indirect Calorimetry
Resting energy expenditure (REE) will be measured by indirect calorimetry in the morning after fasting and under thermoneutral conditions. The measurement will last approximately 30 minutes and REE will be expressed as an absolute value in kilocalories per day. REE will also be standardized according to lean body mass and evaluated according to age and sex. Values will be compared between healthy controls and participants with intestinal failure, as well as between participants with short bowel syndrome and participants with other causes of intestinal failure.
Measured: During the single study visit; REE is assessed over approximately 30 minutes
Secondary outcomes (7)
Lean Body Mass Assessed by Dual-Energy X-Ray Absorptiometry
Lean body mass will be measured by dual-energy X-ray absorptiometry (DXA). The association between lean body mass and resting energy expenditure will be analyzed in all participants.
Measured: During the single study visit, lasting approximately 90 to 120 minutes
Fat Mass Assessed by Dual-Energy X-Ray Absorptiometry
Fat mass will be measured by dual-energy X-ray absorptiometry (DXA). The association between fat mass and resting energy expenditure will be analyzed in all participants.
Measured: During the single study visit, lasting approximately 90 to 120 minutes
Phase Angle Assessed by Bioelectrical Impedance Analysis
Phase angle will be measured by bioelectrical impedance analysis (BIA) as an indicator of cellular integrity and function. The association between phase angle and resting energy expenditure will be analyzed in healthy controls and participants with intestinal failure.
Measured: During the single study visit, lasting approximately 90 to 120 minutes
C-Reactive Protein
C-reactive protein concentration will be determined from a blood sample as a marker of systemic inflammation. Its association with resting energy expenditure will be analyzed in participants with intestinal failure.
Measured: During the single study visit, lasting approximately 90 to 120 minutes
Neutrophil-to-Lymphocyte Ratio
The neutrophil-to-lymphocyte ratio will be calculated from blood cell counts as a marker of systemic inflammation. Its association with resting energy expenditure will be analyzed in participants with intestinal failure.
Measured: During the single study visit, lasting approximately 90 to 120 minutes
Platelet-to-Lymphocyte Ratio
The platelet-to-lymphocyte ratio will be calculated from blood cell counts as a marker of systemic inflammation. Its association with resting energy expenditure will be analyzed in participants with intestinal failure.
Measured: During the single study visit, lasting approximately 90 to 120 minutes
Lymphocyte-to-Monocyte Ratio
The lymphocyte-to-monocyte ratio will be calculated from blood cell counts as a marker of systemic inflammation. Its association with resting energy expenditure will be analyzed in participants with intestinal failure.
Measured: During the single study visit, lasting approximately 90 to 120 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jul 2026
- Study start1 Oct 2025
- Primary completion1 Oct 2026 (estimated)
- Study completion1 Oct 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Intestinal FailureStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- Participants are enrolled non-randomly into one of two parallel groups based on their pre-existing gastrointestinal functional status: healthy controls with normal gastrointestinal function and patients with intestinal failure. Both groups undergo the same protocol-defined assessments during a single study visit, including indirect calorimetry, dual-energy X-ray absorptiometry, bioelectrical impedance analysis, and blood sampling for inflammatory markers.
- Masking
- None (open label)
- Enrolment
- 92 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Institute of Oncology Ljubljana
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07714499
- Sponsor's protocol ID
- ORI2025-12
- Status last verified
- Jul 2026
- First submitted
- 15 Jul 2026
- Last updated
- 20 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Resting Energy Expenditure According to Gastrointestinal Functional Status
- ClinicalTrials.gov ID
- NCT07714499
- Acronym / sponsor ID
- ORI2025-12
- Conditions
- Intestinal Failure, Short Bowel Syndrome
- Keywords
- Resting Energy Expenditure, Indirect Calorimetry, Body Composition, Dual-Energy X-Ray Absorptiometry
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 92 participants (estimated)
- Lead sponsor
- Institute of Oncology LjubljanaUniversity, hospital or other
- Study start
- 1 Oct 2025 (actual)
- Primary completion
- 1 Oct 2026 (estimated)
- Study completion
- 1 Oct 2026 (estimated)
- First posted
- 20 Jul 2026 (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.
This prospective, comparative interventional study will evaluate resting energy expenditure in adults with different gastrointestinal functional status. A total of 92 participants aged 18 to 65 years will be included: 30 healthy adults with normal gastrointestinal function and 62 patients with clinically confirmed intestinal failure. The intestinal failure group will include patients with short bowel syndrome and patients with other causes of intestinal failure.
Participants will be assigned to one of two protocol-defined groups according to their gastrointestinal functional status. Each participant will attend one study visit lasting approximately 90 to 120 minutes. The research procedures will include measurement of resting energy expenditure by indirect calorimetry after an overnight fast, assessment of body composition by dual-energy X-ray absorptiometry and bioelectrical impedance analysis, and blood sampling for inflammatory markers.
The primary objective is to compare resting energy expenditure between healthy participants and patients with intestinal failure and to determine whether resting energy expenditure differs according to the underlying cause of intestinal failure. Secondary objectives are to evaluate the associations between resting energy expenditure, lean body mass, fat mass, phase angle, and inflammatory markers. The results may contribute to more individualized nutritional management of patients with intestinal failure.
Detailed description
Intestinal failure is a condition in which the gastrointestinal tract is unable to provide adequate digestion and absorption of nutrients, electrolytes, and fluids. Patients may therefore require partial or complete parenteral nutrition. Their resting energy expenditure may be affected by the underlying cause of intestinal failure, changes in body composition, nutritional and metabolic status, and systemic inflammation. Accurate assessment of energy requirements is important for planning individualized nutritional support.
This is a prospective, comparative interventional study with two non-randomized, protocol-defined groups. Group A will include 30 healthy adults with normal gastrointestinal function. Group B will include 62 clinically stable patients with confirmed intestinal failure. Within Group B, approximately 38 participants will have short bowel syndrome and 24 will have other causes of type II or type III intestinal failure, including chronic intestinal dysmotility or extensive disease of the small intestinal mucosa.
The study intervention consists of metabolic, body-composition, and laboratory assessments performed according to a standardized research protocol. Each participant will complete the study during one visit at the Institute of Oncology Ljubljana. The visit will last approximately 90 to 120 minutes. Resting energy expenditure will be measured in the morning, after fasting, in a thermoneutral environment using indirect calorimetry. The indirect calorimetry measurement will last approximately 30 minutes and will determine oxygen consumption and carbon dioxide production.
Body composition will be assessed using dual-energy X-ray absorptiometry to measure lean body mass, fat mass, and bone mineral density. Bioelectrical impedance analysis will also be performed to determine phase angle as an indicator of cellular integrity and function. A blood sample will be collected to assess inflammatory markers, including C-reactive protein and calculated neutrophil-to-lymphocyte, platelet-to-lymphocyte, and lymphocyte-to-monocyte ratios.
Resting energy expenditure will be evaluated as an absolute value in kilocalories per day and in standardized forms, including adjustment for lean body mass, age, and sex. The primary analyses will compare resting energy expenditure between healthy participants and patients with intestinal failure and between patients with short bowel syndrome and patients with other causes of intestinal failure.
Secondary analyses will examine the associations between resting energy expenditure and body-composition parameters, phase angle, and inflammatory markers. The study is intended to improve understanding of metabolic requirements in intestinal failure and to support the development of more individualized nutritional recommendations for these patients.
Study design
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Participants are enrolled non-randomly into one of two parallel groups based on their pre-existing gastrointestinal functional status: healthy controls with normal gastrointestinal function and patients with intestinal failure. Both groups undergo the same protocol-defined assessments during a single study visit, including indirect calorimetry, dual-energy X-ray absorptiometry, bioelectrical impedance analysis, and blood sampling for inflammatory markers.
| Arm | Type | Receives |
|---|---|---|
| Healthy Controls | Active comparator | Diagnostic Test: Protocol-Defined Metabolic and Body Composition AssessmentAdults with normal gastrointestinal function who serve as the comparison group. Participants undergo the protocol-defined metabolic, body-composition, and laboratory assessments during a single study visit, including indirect calorimetry after fasting, dual-energy X-ray absorptiometry, bioelectrical impedance analysis, and blood sampling for inflammatory markers. |
| Participants With Intestinal Failure | Experimental | Diagnostic Test: Protocol-Defined Metabolic and Body Composition AssessmentAdults with clinically confirmed intestinal failure, including participants with short bowel syndrome and participants with other causes of intestinal failure. Participants undergo the protocol-defined metabolic, body-composition, and laboratory assessments during a single study visit, including indirect calorimetry after fasting, dual-energy X-ray absorptiometry, bioelectrical impedance analysis, and blood sampling for inflammatory markers. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Age 18 to 65 years
- No diagnosed chronic diseases
- No hospitalization within the previous 30 days
- No acute illness within the previous 14 days
- Age 18 to 65 years
Key exclusion criteria (24 listed)
- Uncontrolled hyperthyroidism or hypothyroidism
- Diabetes mellitus with poor glycemic control
- Adrenal gland disease
- Active inflammatory bowel disease, including Crohn's disease or ulcerative colitis
- Celiac disease
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Protocol-Defined Metabolic and Body Composition AssessmentParticipants undergo a standardized research assessment during one study visit. Resting energy expenditure is measured by indirect calorimetry after fasting. Body composition is assessed by dual-energy X-ray absorptiometry and bioelectrical impedance analysis. Blood samples are collected for the assessment of inflammatory markers. These assessments are performed outside routine clinical care according to the study protocol. | Diagnostic test | Healthy Controls, Participants With Intestinal Failure |
Primary outcome
Resting Energy Expenditure Measured by Indirect Calorimetry
Time frame: During the single study visit; REE is assessed over approximately 30 minutes
Resting energy expenditure (REE) will be measured by indirect calorimetry in the morning after fasting and under thermoneutral conditions. The measurement will last approximately 30 minutes and REE will be expressed as an absolute value in kilocalories per day. REE will also be standardized according to lean body mass and evaluated according to age and sex. Values will be compared between healthy controls and participants with intestinal failure, as well as between participants with short bowel syndrome and participants with other causes of intestinal failure.
7 secondary outcomes
Lean Body Mass Assessed by Dual-Energy X-Ray Absorptiometry
Time frame: During the single study visit, lasting approximately 90 to 120 minutes
Fat Mass Assessed by Dual-Energy X-Ray Absorptiometry
Time frame: During the single study visit, lasting approximately 90 to 120 minutes
Phase Angle Assessed by Bioelectrical Impedance Analysis
Time frame: During the single study visit, lasting approximately 90 to 120 minutes
C-Reactive Protein
Time frame: During the single study visit, lasting approximately 90 to 120 minutes
Neutrophil-to-Lymphocyte Ratio
Time frame: During the single study visit, lasting approximately 90 to 120 minutes
Platelet-to-Lymphocyte Ratio
Time frame: During the single study visit, lasting approximately 90 to 120 minutes
Lymphocyte-to-Monocyte Ratio
Time frame: During the single study visit, lasting approximately 90 to 120 minutes
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Jul 2026.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Protocol-Defined Metabolic and Body Composition Assessment in people with Intestinal Failure and Short Bowel Syndrome, run by Institute of Oncology Ljubljana at 1 site in Slovenia.
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 9 inclusion and 24 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: looking for participants now, as of the sponsor's last update on 20 Jul 2026. 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 Slovenia. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Klemen Schara, MSc (+38631630065, kschara@onko-i.si), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Resting Energy Expenditure Measured by Indirect Calorimetry (time frame: During the single study visit; REE is assessed over approximately 30 minutes). 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 20 Jul 2026.