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Resting Energy Expenditure Comparison in Normal and Intestinal Failure Gastrointestinal Functional Status

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Study Aim

This study aims to compare the Resting Energy Expenditure, measured through Indirect Calorimetry, between healthy individuals and those with intestinal failure, including those with short bowel syndrome, under fasting and thermoneutral conditions.

What is being tested

Protocol-Defined Metabolic and Body Composition Assessment

+ Protocol-Defined Metabolic and Body Composition Assessment

Diagnostic Test
Who is being recruted

Digestive System Diseases+6

+ Gastrointestinal Diseases

+ Intestinal Diseases

From 18 to 65 Years
+33 Eligibility Criteria
See all eligibility criteria
How is the trial designed

Basic Science Study

Interventional
Study Start: October 2025
See protocol details

Summary

Principal SponsorInstitute of Oncology Ljubljana
Study ContactKlemen Schara, MScMore contacts
Last updated: July 20, 2026
Sourced from a government-validated database.Claim as a partner

Study start date: October 1, 2025

Actual date on which the first participant was enrolled.

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.

Principal SponsorInstitute of Oncology Ljubljana
Study ContactKlemen Schara, MScMore contacts
Last updated: July 20, 2026
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details

92 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Basic Science Study

Basic science studies help researchers understand how the body works or how a disease develops. They don't test treatments, but they build the foundation for future therapies.



Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria

Any sex

Biological sex of participants that are eligible to enroll.

From 18 to 65 Years

Range of ages for which participants are eligible to join.

Healthy volunteers allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

Digestive System DiseasesGastrointestinal DiseasesIntestinal DiseasesMalabsorption SyndromesPathologic ProcessesPostoperative ComplicationsPathological Conditions, Signs and SymptomsIntestinal FailureShort Bowel Syndrome

Criteria

9 inclusion criteria required to participate
Stable clinical condition

Diagnostically confirmed intestinal failure

Group A - Healthy Controls

No hospitalization within the previous 30 days

Show More Criteria

24 exclusion criteria prevent from participating
Active ischemic heart disease or recent myocardial infarction

Chronic kidney disease

Advanced liver cirrhosis

Dementia impairing the ability to participate

Show More Criteria

Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.
Treatment Groups
Study Objectives

2 intervention groups are designated in this study

This study does not include a placebo group 

Treatment Groups

Group I

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.

Group II

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.

Study Objectives

Primary Objectives

Secondary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 1 location

Recruiting

Institute of Oncology Ljubljana

Ljubljana, SloveniaOpen Institute of Oncology Ljubljana in Google Maps
Recruiting
One Study Center