Short Bowel Syndrome Clinical Trials

Find Short Bowel Syndrome Clinical Trials Near You

Comparison of Resting Energy Expenditure According to Gastrointestinal Functional Status

Status: Recruiting
Location: See location...
Intervention Type: Diagnostic test
Study Type: Interventional
Study Phase: Not Applicable
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
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 65
Healthy Volunteers: t
View:

⁃ 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

Locations
Other Locations
Slovenia
Institute of Oncology Ljubljana
RECRUITING
Ljubljana
Contact Information
Primary
Klemen Schara, MSc
kschara@onko-i.si
+38631630065
Time Frame
Start Date: 2025-10-01
Estimated Completion Date: 2026-10-01
Participants
Target number of participants: 92
Treatments
Active_comparator: Healthy Controls
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.
Experimental: Participants With Intestinal Failure
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.
Related Therapeutic Areas
Sponsors
Leads: Institute of Oncology Ljubljana

This content was sourced from clinicaltrials.gov

Similar Clinical Trials