RecruitingNot ApplicableNCT07297238

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


Sponsor

Jinling Hospital, China

Enrollment

20 participants

Start Date

Jan 24, 2026

Study Type

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

Min Age: 18 YearsMax Age: 80 Years

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

DRUGGLP-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.


Locations(2)

Jinling Hospital

Nanjing, China, China

Jinling Hospital

Nanning, China, China

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NCT07297238


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