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Effect of GLP-1 on Intestinal Barrier Function in SBS-IF Patients: A Preliminary Exploration. 20 Randomized

Not yet recruiting
Clinical Trial NCT07297238 is an interventional study for Short Bowel Syndrome (SBS), Intestinal Failure and is currently not yet recruiting. Enrollment is planned to begin on 1 January 2026 and continue until the study accrues 20 participants. Led by Jinling Hospital, China, this study is expected to complete by 31 March 2026. The latest data from ClinicalTrials.gov was last updated on 22 December 2025.
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...Show More
Detailed 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 o...Show More
Official Title

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

Conditions
Short Bowel Syndrome (SBS)Intestinal Failure
Publications
Scientific articles and research papers published about this clinical trial:
Other Study IDs
  • 2025-09-17
NCT ID Number
NCT07297238
Start Date (Actual)
2026-01-01
Last Update Posted
2025-12-22
Completion Date (Estimated)
2026-03-31
Enrollment (Estimated)
20
Study Type
Interventional
PHASE
N/A
Status
Not yet recruiting
Keywords
GLP-1
short bowel syndrome
intestinal failure
Intestinal Barrier Function
Primary Purpose
Treatment
Design Allocation
Randomized
Interventional Model
Parallel
Masking
Single
Arms / Interventions
Participant Group/ArmIntervention/Treatment
ExperimentalExperimental arm
Participants received semaglutide as a subcutaneous injection (dosage form) at a dose of 0.25 mg (dosage) once weekly (frequency) for 28 days (duration).
GLP-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.
No InterventionControl arm
received appearance-matched placebo plus standard care, no additional semaglutide intervention therapy
N/A
Primary Outcome Measures
Outcome MeasureMeasure DescriptionTime Frame
Serum Biomarkers of Intestinal Barrier Function
Serum Citrulline（µmol/L）
the initiation of enrollment and upon completion of the 28-days treatment period
Secondary Outcome Measures
Outcome MeasureMeasure DescriptionTime Frame
Intestinal absorption of nutrients (protein)
Intestinal nitrogen balance（Kjeldahl method for total nitrogen intake and excretion）
the initiation of enrollment and upon completion of the 28-days treatment period
Intestinal absorption of nutrients (carbohydrate)
Fecal carbohydrate（Fecal pH measurement and analysis of fermentable substrates for indirect assessment）
the initiation of enrollment and upon completion of the 28-days treatment period
Intestinal absorption of nutrients (fat)
Fat excretion rates（van de Kamer method for direct measurement of total fecal fat excretion）
the initiation of enrollment and upon completion of the 28-days treatment period
Nutritional status indicator
Serum albumin (g/L) level
the initiation of enrollment and upon completion of the 28-days treatment period
PN Liberation Rate
A 20% reduction in the weekly parenteral nutrition volume from baseline
the initiation of enrollment and upon completion of the 28-days treatment period
Quality of life score
Quality of life was assessed using the SF-36 score from the date of randomization until the end of the 4-week intervention weeks. SF-36 consists of eight dimensions, each of which is measured on a scale of 0-100, with higher scores indicating a better quality of life.
the initiation of enrollment and upon completion of the 28-days treatment period
Participation Assistant
Eligibility Criteria

Eligible Ages
Adult, Older Adult
Minimum Age
18 Years
Eligible Sexes
All

  • 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.

  • 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.
Jinling Hospital, China logoJinling Hospital, China
Study Responsible Party
Wang Xinying, Principal Investigator, Prof, Jinling Hospital, China
Study Central Contact
Contact: Xin Qi, MD, +86 18088680475, [email protected]
Contact: Xinying Wang, MD, +86 13913028866, [email protected]
1 Study Locations in 1 Countries

China

Jinling Hospital, Nanning, China, 210002, China