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.
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;
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);
Parallel
washed microbiota transplantation
Other interventionEach patient will receive washed microbiota transplantation each day for three consecutive days. After WMT, participants will receive free diet plus home enteral nutrition (solution at a 750ml daily dosage that provides 750 kcal energy) at home for 8 weeks.
Changes of weight and height
Weight and height will be combined to report BMI in kg/m\^2.
Changes of the third lumbar vertebrae skeletal muscle mass and height
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
Changes of Patient-Generated Subjective Global Assessment (PG-SGA)
Patient-Generated Subjective Global Assessment (PG-SGA) includes patient-generated historical components (Weight History, Food Intake, Symptoms and Activities and Function) and the professional part (Diagnosis, Age, Metabolic stress, and Physical Exam).
Changes of the Gastrointestinal Symptom Rating Scale(GSRS)
GSRS is a 13-item test to make a comprehensive assessment of common gastrointestinal symptom and each item receives a value from 0 to 3, with higher value indicating worse gastrointestinal condition.
60-day readmission rate
The 60-day readmission is recorded and defined as nonelective readmission within 60 days after the treatment.
The incidence of treatment-related adverse events (AE) assessed by CTCAE, Version 5.0
The severity of AE was graded as mild (grade 1), moderate (grade 2), severe/disabling (grade 3), life threatening (grade 4), and death (grade 5). All AE were divided in definitely, probably and possibly related to treatment. The treatment-related AE we focused on included microbiota-related AEs (e.g., infection, diarrhea, abdominal pain, etc.) and route of delivery related AEs (e.g., nausea, vomiting, etc.).
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The Second Hospital of Nanjing Medical University
Lead sponsor
The First Affiliated Hospital of Guangdong Pharmaceutical University
Collaborator
Nanjing Medical University
Collaborator
Wuxi No. 2 People's Hospital
Collaborator
Jiangxi University of Chinese Medicine Affiliated Hospital
Collaborator
Hubei Hospital of Traditional Chinese Medicine
Collaborator
The Affiliated Hospital Of Southwest Medical University
Collaborator
Tang-Du Hospital
Collaborator
Huzhou Central Hospital
Collaborator
West China Fourth Hospital
Collaborator
The Affiliated People's Hospital of Ningbo University
Collaborator
Guangzhou First People Hospital of Guangzhou Medical University
Collaborator
The First Affiliated Hospital of Anhui University of Chinese Medicine
Collaborator
Beijing Rectum Hospital
Collaborator
Dazhou Central Hospital
Collaborator
The Second Affiliated Hospital of Dalian Medical University
Collaborator
Second Affiliated Hospital of Guangzhou Medical University
Collaborator
PLA No. 901 Hospital of the Joint Support Force
Collaborator
YI'AN PEOPLE'S HOSPITAL
Collaborator
Hunan Aerospace Hospital
Collaborator
Jiamusi City Hospital of Traditional Chinese Medicine
Collaborator
The First People's Hospital of Kunshan
Collaborator
LanZhou University
Collaborator
Jingxing xian yiyuan
Collaborator
TAIHE country people's hospital
Collaborator
Tailai County People's Hospital
Collaborator
Armed Police Characteristic Medical Center
Collaborator
First Affiliated Hospital Xi'an Jiaotong University
Collaborator
