Effect of GLP-1 on Intestinal Barrier Function in SBS-IF Patients: A Preliminary Exploration.
Therapeutic Efficacy of GLP-1 on Intestinal Barrier Function in Patients With Short Bowel Syndrome and Intestinal Failure: A Preliminary Randomized Controlled Trial
Jinling Hospital, China
20 participants
Jan 24, 2026
INTERVENTIONAL
Conditions
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.
Eligibility
Inclusion Criteria21
- 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.
- 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.
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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.
Locations(2)
View Full Details on ClinicalTrials.gov
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NCT07297238