Intestinal Failure, Short Bowel Syndrome (SBS)
Conditions
Keywords
GLP-1, short bowel syndrome, intestinal failure, Intestinal Barrier Function
Brief summary
Eligible patients were randomized into two groups: the GLP-1 group and the control group. The control group received a placebo along with standard care, without any additional GLP-1-based intervention. The GLP-1 group, in addition to standard care, received a subcutaneous injection of a GLP-1 analog (semaglutide injection) strictly according to the drug manufacturer's instructions. The initial dose of semaglutide was 0.25 mg once weekly. Treatment was continued over a 28-days period. Primary and secondary outcomes will be collected.
Detailed description
Eligible patients with short bowel syndrome and intestinal failure were randomly assigned to one of two groups: the GLP-1 group or the control group. The control group received a placebo along with standard care. The GLP-1 group, in addition to standard care, was administered a GLP-1 analog (semaglutide injection) via subcutaneous injection strictly according to the manufacturer's instructions, with an initial dose of semaglutide of 0.25 mg once weekly. Primary and secondary outcomes will be collected.
Interventions
GLP-1 receptor agonists (semaglutide) are medications that mimic the action of the native human hormone glucagon-like peptide-1 (GLP-1). The recommended dosage is 0.25 mg administered subcutaneously once weekly.
Sponsors
Jinling Hospital, China
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
* Participants voluntarily provided written informed consent for this trial; * Aged 18 to 80 years, inclusive, regardless of gender; * With stable vital signs; * Diagnosis of SBS-IF, confirmed by existing medical/surgical records, receiving parenteral nutrition (PN) due to surgical resection of the small intestine (\<200 cm from the duodenojejunal flexure), and meeting one of the following criteria: * Colon continuity maintained without jejunal/ileal stoma (Type II or III); * Presence of a jejunostomy or ileostomy (Type I); * Expected requirement of PN for more than 4 weeks, with an average PN caloric intake ≥80%; * Ability to comply with the medication dosing and visit schedule; * Capacity to accurately describe symptoms, absence of severe infections or respiratory insufficiency, and willingness to cooperate proactively; * No history of allergic diseases, non-allergic constitution, and no hypersensitivity to any component of semaglutide injection; * No history of drug abuse; * Not pregnant or lactating; no pregnancy plans within one month after the trial (applies to both female and male participants); * No participation in any other drug trials (including the investigational product in this study) within three months prior to enrollment.
Exclusion criteria
* Individuals who do not meet the inclusion criteria or are deemed ineligible by the investigator; * Poor general condition, inability to accurately describe symptoms, presence of severe infection, respiratory insufficiency, or other conditions that may hinder active cooperation; * History of allergic diseases, allergic constitution, or hypersensitivity to drugs structurally related to the investigational product; * Patients with malignancy at any site; * Those with psychiatric disorders, inability to cooperate, or impaired consciousness; * Patients with contraindications to the investigational drug (including personal or family history of medullary thyroid carcinoma or multiple endocrine neoplasia type 2); * Immunodeficiency, or current use of immunosuppressants or corticosteroids; * Immediate family members of the sponsor, investigator, or study staff directly involved in the trial; * Any other condition considered by the investigator as grounds for exclusion.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Serum Biomarkers of Intestinal Barrier Function | the initiation of enrollment and upon completion of the 28-days treatment period | Serum Citrulline（µmol/L） |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Intestinal absorption of nutrients (protein) | the initiation of enrollment and upon completion of the 28-days treatment period | Intestinal nitrogen balance（Kjeldahl method for total nitrogen intake and excretion） |
| Intestinal absorption of nutrients (carbohydrate) | the initiation of enrollment and upon completion of the 28-days treatment period | Fecal carbohydrate（Fecal pH measurement and analysis of fermentable substrates for indirect assessment） |
| Intestinal absorption of nutrients (fat) | the initiation of enrollment and upon completion of the 28-days treatment period | Fat excretion rates（van de Kamer method for direct measurement of total fecal fat excretion） |
| Nutritional status indicator | the initiation of enrollment and upon completion of the 28-days treatment period | Serum albumin (g/L) level |
| PN Liberation Rate | the initiation of enrollment and upon completion of the 28-days treatment period | A 20% reduction in the weekly parenteral nutrition volume from baseline |
| Quality of life score | the initiation of enrollment and upon completion of the 28-days treatment period | Quality of life was assessed using the SF-36 score from the date of randomization until the end of the 4-week intervention weeks. SF-36 consists of eight dimensions, each of which is measured on a scale of 0-100, with higher scores indicating a better quality of life. |
Countries
China
Contacts
PRINCIPAL_INVESTIGATORXinying Wang, MD
Jinling Hospital, China
Outcome results
None listed