An interventional study of Protocol-Defined Metabolic and Body Composition Assessment in Intestinal Failure and Short Bowel Syndrome, sponsored by Institute of Oncology Ljubljana. Recruiting at 1 site in Slovenia. Open to participants aged 18 Years to 65 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-07-20.
Sponsored by Institute of Oncology Ljubljana · Not applicable, Interventional, and Basic science
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.
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.
64 studies on the registry are indexed under Intestinal Failure; 17 are open to participants now.
This study's planned enrollment of 92 is above the median of 38 across 42 interventional studies indexed under Intestinal Failure.
Browse Intestinal Failure studies →Institute of Oncology Ljubljana is the lead sponsor of 81 studies on the registry; 26 are open to participants now.
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Group A - Healthy Controls:
Group B - Participants With Intestinal Failure:
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Chronic obstructive pulmonary disease: long-term lung disease that makes it hard to breathe out, including emphysema and chronic bronchitis.
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
A condition in which the immune system attacks the body’s own tissues, such as rheumatoid arthritis, lupus, psoriasis, type 1 diabetes or inflammatory bowel disease.
Immunotherapy studies often leave out active autoimmune disease, and some name exceptions, such as thyroid disease on replacement hormone. Check the exceptions this study lists.
COPD
Chronic obstructive pulmonary disease: long-term lung disease that makes it hard to breathe out, including emphysema and chronic bronchitis.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
HIV
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Clinically significant
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Immunosuppression
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Autoimmune disease
A condition in which the immune system attacks the body’s own tissues, such as rheumatoid arthritis, lupus, psoriasis, type 1 diabetes or inflammatory bowel disease.
Immunotherapy studies often leave out active autoimmune disease, and some name exceptions, such as thyroid disease on replacement hormone. Check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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.
Diagnostic Test: Protocol-Defined Metabolic and Body Composition Assessment
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.
Diagnostic Test: Protocol-Defined Metabolic and Body Composition Assessment
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.
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.
Time frame: During the single study visit; REE is assessed over approximately 30 minutes
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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: During the single study visit, lasting approximately 90 to 120 minutes
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Institute of Oncology Ljubljana