Therapeutic Efficacy of GLP-1 on Intestinal Barrier Function in Patients With Short Bowel Syndrome and Intestinal Failure: A Preliminary Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 20
- 试验地点
- 2
- 主要终点
- Serum Biomarkers of Intestinal Barrier Function
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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.
研究组 & 干预措施
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).
干预措施: GLP-1 Receptor Agonists (Drug)
Control arm
received appearance-matched placebo plus standard care, no additional semaglutide intervention therapy
结局指标
主要结局
Serum Biomarkers of Intestinal Barrier Function
时间窗: the initiation of enrollment and upon completion of the 28-days treatment period
Serum Citrulline（µmol/L）
次要结局
- 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)
- Nutritional status indicator(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)
- PN Liberation Rate(the initiation of enrollment and upon completion of the 28-days treatment period)
- Quality of life score(the initiation of enrollment and upon completion of the 28-days treatment period)
研究者
Wang Xinying
Prof
Jinling Hospital, China