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

Led by Jinling Hospital, China · Updated on 2026-07-14

Participants Needed

Research Sites

4 weeks

Total Duration

AI-Summary

What this Trial Is 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.

CONDITIONS

Brief Title

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

Who Can Participate

Age: 18Years - 80Years

All Genders

Eligibility Criteria

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.

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

On this page

AI-Summary

What this Trial Is About

Brief Title

Who Can Participate

Eligibility Criteria

Not the Right Trial for You?

On this page

Who Can Participate

Eligibility Criteria