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Recruiting Not applicable NCT07297238

Effect of GLP-1 on Intestinal Barrier Function in SBS-IF Patients: A Preliminary Exploration.

No applicable phase (e.g. observational)
Conditions: Short Bowel Syndrome (SBS) Intestinal Failure

Sponsor: Jinling Hospital, China

trial.available_in: БГ
Overview
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.
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.
Who can participate
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.
Interventions
GLP-1 Receptor Agonists
DRUG
Locations 2
China (2)
Jinling Hospital
Nanjing , China
Jinling Hospital
Nanning , China
Technical details
Status
Recruiting
Phase
Not applicable
Study type
INTERVENTIONAL
Sex
Male and female
Minimum age
18 Years
Maximum age
80 Years
Healthy volunteers
No
Start date
24.01.2026
Completion date
31.05.2026
Registry ID
NCT07297238
Source
clinicaltrials.gov
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