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

NCT07297238 | Recruiting DMC

• 1 other identifier: 2025-09-17
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 2

Brief 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.

Conditions

Short Bowel Syndrome (SBS); Intestinal Failure

Keywords

GLP-1; short bowel syndrome; intestinal failure; Intestinal Barrier Function

Outcome Measures

Primary Outcomes (1)

• Serum Biomarkers of Intestinal Barrier Function

  Serum Citrulline（µmol/L）

  the initiation of enrollment and upon completion of the 28-days treatment period

Secondary Outcomes (6)

• Intestinal absorption of nutrients (protein)

  the initiation of enrollment and upon completion of the 28-days treatment period

• Intestinal absorption of nutrients (carbohydrate)

  the initiation of enrollment and upon completion of the 28-days treatment period

• Intestinal absorption of nutrients (fat)

  the initiation of enrollment and upon completion of the 28-days treatment period

• Nutritional status indicator

  the initiation of enrollment and upon completion of the 28-days treatment period

• PN Liberation Rate

  the initiation of enrollment and upon completion of the 28-days treatment period

Study Arms (2)

Experimental arm

EXPERIMENTAL

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

Drug: GLP-1 Receptor Agonists

Control arm

NO INTERVENTION

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

Interventions

GLP-1 Receptor Agonists DRUG

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.

Also known as: GLP-1RAs

Experimental arm

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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;

Sponsors & Collaborators

• Jinling Hospital, China: lead

Study Sites (2)

Jinling Hospital

Nanjing, China, 210002, China

RECRUITING

Jinling Hospital

Nanning, China, 210002, China

RECRUITING

Related Publications (14)

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MeSH Terms

Conditions

Short Bowel Syndrome; Intestinal Failure

Interventions

Glucagon-Like Peptide-1 Receptor Agonists

Condition Hierarchy (Ancestors)

Malabsorption Syndromes; Intestinal Diseases; Gastrointestinal Diseases; Digestive System Diseases; Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Hypoglycemic Agents; Physiological Effects of Drugs; Pharmacologic Actions; Chemical Actions and Uses

Study Officials

• Xinying Wang, MD

  Jinling Hospital, China

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Xin Qi, MD

CONTACT

+86 18088680475; qixin199604@126.com

Xinying Wang, MD

CONTACT

+86 13913028866; wangxinying@nju.edu.cn

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Prof

Study Record Dates

• First Submitted: September 19, 2025
• First Posted: December 22, 2025
• Study Start: January 24, 2026
• Primary Completion (Estimated): May 30, 2026
• Study Completion (Estimated): May 31, 2026
• Last Updated: April 23, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

CN (2)