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NOT YET RECRUITING

NCT07297238

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

Sponsor: Jinling Hospital, China

View on ClinicalTrials.gov

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.

Official title: Therapeutic Efficacy of GLP-1 on Intestinal Barrier Function in Patients With Short Bowel Syndrome and Intestinal Failure: A Preliminary Randomized Controlled Trial

Key Details

Gender

All

Age Range

18 Years - 80 Years

Study Type

INTERVENTIONAL

Enrollment

Start Date

2026-01-01

Completion Date

2026-03-31

Last Updated

2025-12-22

Healthy Volunteers

Conditions

Short Bowel Syndrome (SBS)Intestinal Failure

Interventions

DRUG

GLP-1 Receptor Agonists

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.

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.

Locations (1)

Jinling Hospital

Nanning, China, China