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治験 NCT07297238（対象：短腸症候群 (SBS)、腸不全）は募集準備中です。詳細は治験レーダーのタイル表示と AI 発見ツールで確認するか、ここで質問してください。 | ||
Effect of GLP-1 on Intestinal Barrier Function in SBS-IF Patients: A Preliminary Exploration. 20 無作為化
Therapeutic Efficacy of GLP-1 on Intestinal Barrier Function in Patients With Short Bowel Syndrome and Intestinal Failure: A Preliminary Randomized Controlled Trial
- 2025-09-17
short bowel syndrome
intestinal failure
Intestinal Barrier Function
| 参加グループ/群 | 介入/治療法 |
|---|---|
実験的Experimental 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. |
非介入Control arm received appearance-matched placebo plus standard care, no additional semaglutide intervention therapy | 該当なし |
| 評価指標 | 指標の説明 | 時間枠 |
|---|---|---|
Serum Biomarkers of Intestinal Barrier Function | Serum Citrulline（µmol/L） | the initiation of enrollment and upon completion of the 28-days treatment period |
| 評価指標 | 指標の説明 | 時間枠 |
|---|---|---|
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 |
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, ChinaChina