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

Jinling Hospital, China

Status: Not yet enrolling

Conditions: Intestinal Failure; Short Bowel Syndrome (SBS)

Treatments: Drug: GLP-1 Receptor Agonists

Study type: Interventional

Funder types: Other

Identifiers

NCT07297238

2025-09-17

Details and patient eligibility

About

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.

Full 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.

Enrollment: 20 estimated patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

---

20 participants in 2 patient groups

Experimental arm

Experimental group

Description:

Participants received semaglutide as a subcutaneous injection (dosage form) at a dose of 0.25 mg (dosage) once weekly (frequency) for 28 days (duration).

Treatment:

Drug: GLP-1 Receptor Agonists

Control arm

No Intervention group

Description:

received appearance-matched placebo plus standard care, no additional semaglutide intervention therapy