NCT07714499 Resting Energy Expenditure by Gastrointestinal Functional Status
| NCT ID | NCT07714499 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Institute of Oncology Ljubljana |
| Condition | Intestinal Failure |
| Study Type | INTERVENTIONAL |
| Enrollment | 92 participants |
| Start Date | 2025-10-01 |
| Primary Completion | 2026-10-01 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 92 participants in total. It began in 2025-10-01 with a primary completion date of 2026-10-01.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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 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.
Eligibility Criteria
Inclusion Criteria: 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: * Age 18 to 65 years * Diagnostically confirmed intestinal failure * Stable clinical condition Exclusion Criteria: * 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 * 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
Contact & Investigator
Frequently Asked Questions
Who can join the NCT07714499 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 65 Years, studying Intestinal Failure. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT07714499 currently recruiting?
Yes, NCT07714499 is actively recruiting participants. Contact the research team at kschara@onko-i.si for enrollment information.
Where is the NCT07714499 trial being conducted?
This trial is being conducted at Ljubljana, Slovenia.
Who is sponsoring the NCT07714499 clinical trial?
NCT07714499 is sponsored by Institute of Oncology Ljubljana. The trial plans to enroll 92 participants.