Skip to main content
OpenTrials
Completed

NCT Number: NCT07297238

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

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.

Completed

Looking for future studies?

Notify Me

Key information

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Jinling Hospital, Nanjing, China

Loading trial locations.

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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.

Other names: GLP-1RAs

Primary outcomes

  1. Serum Biomarkers of Intestinal Barrier Function

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

    Serum Citrulline(µmol/L)

Secondary outcomes

  1. Intestinal absorption of nutrients (protein)

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

    Intestinal nitrogen balance(Kjeldahl method for total nitrogen intake and excretion)

  2. Intestinal absorption of nutrients (carbohydrate)

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

    Fecal carbohydrate(Fecal pH measurement and analysis of fermentable substrates for indirect assessment)

  3. Intestinal absorption of nutrients (fat)

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

    Fat excretion rates(van de Kamer method for direct measurement of total fecal fat excretion)

  4. Nutritional status indicator

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

    Serum albumin (g/L) level

  5. PN Liberation Rate

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

    A 20% reduction in the weekly parenteral nutrition volume from baseline

  6. Quality of life score

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

    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.

Sponsors and collaborators

Lead sponsor

Jinling Hospital, China

Other

Registry information

Official study title

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

Important dates

Study start
2026
Primary completion
2026
Study completion
2026
First posted
Dec 22, 2025
Registry last updated
Jul 14, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.