An Open-label, Multicenter, Randomized Clinical Trial for Malnutrition After Nonphysiological Reconstruction of the Upper Gastrointestinal Tract: Washed Microbiota Transplantation Via Mid-gut Tube Versus Colonic Transendoscopic Enteral Tube
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 62
- 试验地点
- 1
- 主要终点
- Changes of weight and height
研究概览
简要总结
This is a prospective, randomized, multicenter study to evaluate WMT in improving nutritional status in malnourished patients who underwent nonphysiological reconstruction of the upper gastrointestinal tract. In this multicenter trial, sixty-two patients will be enrolled in forteen Chinese sites. Participants will be randomized at a ratio of 1:1 to receive three WMTs through either mid-gut tube or colonic TET. After WMT, each participant will receive free diet plus home enteral nutrition. Home enteral nutrition should last for 2 months at home, with blood, urine and stool samples taken and stored at baseline and 2 months after WMT.
详细描述
Background: Malnutrition is a common complication of nonphysiological reconstruction of the upper gastrointestinal tract. The potential of washed microbiota transplantation (WMT) in improving nutritional status have been reported. The surgery procedure alters the anatomy and physiology of the digestive tract, which might impact the efficacy and safety of WMT when choosing different delivery way. This study aims to explore the optimal delivery of WMT in malnourished patients after rerouting of the upper gastrointestinal tract.
Methods and design: This multicenter, open-label, and randomized controlled trial will be conducted at forteen hospitals in China. Enteral nutrition (EN) will be administrated at enrollment. Participants will be then randomized at a ratio of 1:1 to receive three WMTs through either mid-gut tube or colonic transendoscopic enteral tubing (TET). Then the patients will receive free diet coupled with home enteral nutrition (HEN) for 8 weeks in both groups, with blood, urine and stool samples taken and stored at baseline and 2 months after WMT. The observation duration is 8 weeks. The primary endpoint is nutritional status of the patients. The nutritional status data obtained at baseline and 8 weeks after discharge includes body mass index (BMI) and skeletal muscle index (SMI). The secondary endpoints are nutritional assessment, nutrition-based laboratory indices, 60-day readmission rate, quality of life, gastrointestinal symptom scale, the safety of WMT and further analysis of the biological specimens.
Conclusion: It is estimated that WMT would help improve nutrition status. Moreover, this trial has the potential to identify the optimal delivery of WMT for patients undergoing nonphysiological reconstruction of the upper gastrointestinal tract.
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
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients undergone nonphysiological reconstruction of the gastrointestinal tract (such as Billroth-II, Roux-en-Y, Child, Whipple reconstruction)
- •Aged over 18 years old;
- •Malnutrition is assessed by Nutritional Risk Screening 2002 score≥3 and Patient Generated Subjective Global Assessment (PG-SGA) score≥4;
- •Written informed consent;
排除标准
- •Expected survival time < 3 months;
- •Still on anti-tumor therapy or it is expected during the visit;
- •Complicated with ascites or edema caused by malnutrition;
- •Known organic gastrointestinal disease (e.g., gastrointestinal infection, inflammatory bowel disease, or radiation enteritis);
- •Undergone other gastrointestinal surgery (e.g., enterectomy, enterostomy, or gastrostomy) except appendectomy or anal fistula surgery;
- •Complicated with contraindications of enteral nutrition such as ileus, active gastrointestinal bleeding, and shock;
- •Cannot tolerate gastroscopy or colonoscopy;
- •Severe comorbidities (e.g., diabetes, cardiopulmonary failure, severe liver or or kidney diseases);
- •Complicated with other wasting diseases (e.g., active tuberculosis, hyperthyroidism, diabetes, HIV, active hepatitis, hip fracture, craniocerebral injury, etc.);
- •A history of anti-infective treatment within 30 days before enrollment; or need anti-infective treatment at the time of enrollment; or unwilling to stop taking drugs that affect gut microbes, such as probiotics;
- •Can not tolerate oral enteral nutrition;
- •Women who are pregnant or breastfeeding;
- •Participating in another clinical trial;
- •Deemed unsuitable for inclusion by the investigators.
结局指标
主要结局
Changes of weight and height
时间窗: baseline, 8 weeks post transplantation
Weight and height will be combined to report BMI in kg/m\^2.
Changes of the third lumbar vertebrae skeletal muscle mass and height
时间窗: baseline, 8 weeks post transplantation
The third lumbar vertebrae skeletal muscle mass represents the sum of the cross-sectional areas of the skeletal muscles at the L3 level, including the psoas major, the erector spinae, the quadratus lumborum, the musculus transversus abdominis, the obliquus externus abdominis and the obliquus internus abdominis. Skeletal muscle mass and height will be combined to report the third lumbar vertebrae skeletal muscle mass index(L3 SMI) in cm\^2/m\^2.
Changes of weight
时间窗: baseline, 8 weeks post transplantation
Changes of weight and height
时间窗: baseline, 8 weeks post transplantation
Weight and height will be combined to report BMI in kg/m\^2.
Changes of the third lumbar vertebrae skeletal muscle mass and height
时间窗: baseline, 8 weeks post transplantation
The third lumbar vertebrae skeletal muscle mass represents the sum of the cross-sectional areas of the skeletal muscles at the L3 level, including the psoas major, the erector spinae, the quadratus lumborum, the musculus transversus abdominis, the obliquus externus abdominis and the obliquus internus abdominis. Skeletal muscle mass and height will be combined to report the third lumbar vertebrae skeletal muscle mass index(L3 SMI) in cm\^2/m\^2.
次要结局
- Changes of Patient-Generated Subjective Global Assessment (PG-SGA)(baseline, 8 weeks post transplantation)
- Changes of the Gastrointestinal Symptom Rating Scale(GSRS)(baseline, 4 weeks, 8 weeks post transplantation)
- 60-day readmission rate(From enrollment to the end of treatment at 8 weeks)
- The incidence of treatment-related adverse events (AE) assessed by CTCAE, Version 5.0(From enrollment to the end of treatment at 8 weeks)
- Changes of the 5-level EuroQoL Group's 5-dimension (EQ-5D-5L)(baseline, 4 weeks, 8 weeks post transplantation)
- Changes of the Pittsburgh Sleep Quality Index (PSQI)(baseline, 4 weeks, 8 weeks post transplantation)
- Changes of the Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-Fatigue)(baseline, 4 weeks, 8 weeks post transplantation)
- The difference of the gut microbiota composition before and after washed microbiota transplantation(baseline, 8 weeks post transplantation)
- Change of insulin-like growth factor I(IGF-I)(baseline, 8 weeks post transplantation)
- Changes of hemoglobin(baseline, 8 weeks post transplantation)
- Changes of albumin(baseline, 8 weeks post transplantation)
- Changes of prealbumin(baseline, 8 weeks post transplantation)
- Changes of cholesterol(baseline, 8 weeks post transplantation)
- Changes of transferrin(baseline, 8 weeks post transplantation)
- Changes of C-reactive protein(baseline, 8 weeks post transplantation)
- Changes of full spectrum of bile acidsare(baseline, 8 weeks post transplantation)
- Changes of glucose breath testing(baseline, 8 weeks post transplantation)
研究者
Faming Zhang
Associate professor, Gastroenterology
The Second Hospital of Nanjing Medical University