NCT06837194招募中不适用
The Efficacy of WMT Combined with Nutritional Support in the Treatment of Malnutrition Complicated by Gastroptosis: a Real-World Study
The Second Hospital of Nanjing Medical University1 个研究点 分布在 1 个国家目标入组 24 人开始时间: 2025年2月1日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 24
- 试验地点
- 1
- 主要终点
- The proportion of gastroptosis with degree relief after the procedure.
研究概览
简要总结
This is a observational study to explore the efficacy and safety of washed microbiota transplantation (WMT) combined with nutritional support for gastroptosis patients
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 100 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Subjects must meet all of the following inclusion criteria to enter the study:
- •Clinically diagnosed with gastroptosis;
- •Meets the diagnostic criteria for malnutrition (fulfilling any one of the following two criteria):
- •Weight loss (weight loss >5% within the last 6 months or >10% over more than 6 months);
- •Low BMI (BMI <18.5 kg/m² for individuals <70 years old; BMI <20 kg/m² for individuals ≥70 years old);
- •Males aged ≥18 years and non-pregnant, non-lactating females aged ≥18 years;
- •Willing to voluntarily sign a written informed consent form and agrees to follow medical advice for regular follow-up examinations and monitoring after the completion of treatment.
排除标准
- •Subjects meeting any of the following exclusion criteria must be excluded from the study:
- •Patients with severe depression, anxiety, or cognitive impairment that affects normal physician-patient communication and treatment planning;
- •Patients with poor compliance who cannot accept treatment regimens such as nasogastric enteral nutrition;
- •Anticipated survival time <3 months;
- •Clinically significant cardiovascular diseases, including heart failure (NYHA Class III-IV), uncontrolled coronary artery disease, cardiomyopathy, arrhythmia, history of myocardial infarction, hemodynamic instability at enrollment, unstable vital signs, or anticipated risk events during treatment;
- •Poor pulmonary function deemed by investigators to impact study treatment (e.g., acute exacerbation of COPD or requirement for long-term oral/intravenous corticosteroids [excluding inhaled corticosteroids]);
- •Active severe clinical infections (> Grade 2 per NCI-CTCAE v5.0), including patients with intestinal fungal, viral, or tuberculosis infections;
- •Inability to cooperate with intestinal tube placement or contraindications to intestinal tube placement;
- •Use of medications affecting or modulating gut microbiota within the past 48 hours;
- •Lack of legal capacity or restricted legal capacity;
- •Hematologic disorders unsuitable for blood draw examinations;
- •Other severe medical conditions deemed by investigators to preclude patient enrollment.
结局指标
主要结局
The proportion of gastroptosis with degree relief after the procedure.
时间窗: baseline, 12 weeks post transplantation
Detailed evaluation content of efficacy rate of degree: The ultrasound examination was divided into three levels of light, medium and heavy according to the specific value of the middle gastric angle below Iliac spines are connected, defined as a reduction of at least 50% in value or a reduction of degree.
次要结局
- The extent of change observed in gastrointestinal ultrasound (GIUS) of participants(baseline, 12 weeks post transplantation)
- change of the third lumbar vertebrae skeletal muscle mass and height(baseline, 12 weeks post transplantation)
- change of weight and height(baseline, 4 weeks, 8 weeks, 12 weeks post transplantation)
- change of the Gastrointestinal Symptom Rating Scale(GSRS)(baseline, 4 weeks, 8 weeks, 12 weeks post transplantation)
- The extent of change observed in Gastroparesis Cardinal Symptom Index(GCSI)of participants(baseline, 4 weeks, 8 weeks, 12 weeks post transplantation)
- The results of gastric fitted emptying rate data for 2 hours or 4 hours in the gastric emptying experiment with nuclide imaging(baseline, 12 weeks post transplantation)
- change of the 5-level EuroQoL Group's 5-dimension (EQ-5D-5L)(baseline, 4 weeks, 8 weeks, 12 weeks post transplantation)
- change of the Pittsburgh Sleep Quality Index (PSQI)(baseline, 4 weeks, 8 weeks, 12 weeks post transplantation)
- change of the Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-Fatigue)(baseline, 4 weeks, 8 weeks, 12 weeks post transplantation)
- The extent of change observed in transcranial Doppler (TCD) of participants(baseline, 12 weeks post transplantation)
- change of the Hamilton Anxiety Scale(HAMA)(baseline, 4 weeks, 8 weeks, 12 weeks post transplantation)
- change of the Hamilton Depression Scale(HAMD）(baseline, 4 weeks, 8 weeks, 12 weeks post transplantation)
- change of insulin-like growth factor I(IGF-I)(baseline, 12 weeks post transplantation)
- change of albumin and Prealbumin(baseline, 12 weeks post transplantation)
- change of cytokine(baseline, 12 weeks post transplantation)
- The changes in gut microbiota composition and metabolites before and after treatment(baseline, 12 weeks post transplantation)
- the incidence of treatment-related adverse events (AE) assessed by CTCAE, Version 5.0(12 weeks post transplantation)
研究者
Faming Zhang
Professor, Gastroenterology
The Second Hospital of Nanjing Medical University
研究点 (1)
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