Semaglutide (GLP-1) to support gut barrier function in short bowel syndrome with intestinal failure
Therapeutic Efficacy of GLP-1 on Intestinal Barrier Function in Patients With Short Bowel Syndrome and Intestinal Failure: A Preliminary Randomized Controlled Trial
This test sees if a weekly semaglutide injection helps the gut lining in adults with short bowel syndrome and intestinal failure who rely on parenteral (IV) nutrition.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 20 (estimated) |
| Ages | 18 Years to 80 Years |
| Sex | All |
| Sponsor | Jinling Hospital, China Academic / other |
| Locations | 2 sites (Nanjing, China and 1 other locations) |
| Trial ID | NCT07297238 on ClinicalTrials.gov |
What this trial studies
Eligible adults with short bowel syndrome and intestinal failure are randomized to receive either weekly subcutaneous semaglutide (starting 0.25 mg once weekly) plus standard care or placebo plus standard care for 28 days. Primary and secondary outcomes related to intestinal barrier function and clinical status are collected during and after treatment. Dosing follows the manufacturer's instructions and participants attend scheduled visits for safety monitoring and symptom reporting. The trial is conducted at two Jinling Hospital sites in China.
Who should consider this trial
Good fit: Adults aged 18–80 with documented short bowel syndrome and intestinal failure who receive ≥80% of calories from parenteral nutrition, expect PN for more than 4 weeks, and can comply with dosing and visits.
Not a fit: Patients with severe infections, respiratory insufficiency, known hypersensitivity to semaglutide, inability to comply with study procedures, or those not dependent on parenteral nutrition are unlikely to receive benefit.
Why it matters
Potential benefit: If successful, semaglutide could strengthen the intestinal barrier and potentially reduce complications or dependence on parenteral nutrition for people with short bowel syndrome.
How similar studies have performed: Direct evidence for GLP-1 analogs like semaglutide in SBS is limited and exploratory, while GLP-2 analogs such as teduglutide have previously shown benefit in reducing parenteral support.
Eligibility criteria
Show full inclusion / exclusion 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.
Where this trial is running
Nanjing, China and 1 other locations
- Jinling Hospital — Nanjing, China, China (Recruiting)
- Jinling Hospital — Nanning, China, China (Recruiting)
Study contacts
- Principal investigator: Xinying Wang, MD — Jinling Hospital, China
- Study coordinator: Xin Qi, MD
- Email: qixin199604@126.com
- Phone: +86 18088680475
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.