About this trial
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.
Eligibility criteria
Qualifiers
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;
Disqualifiers
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);
Trial design
Treatments tested in this trial
- washed microbiota transplantation
Treatment groups
Sponsors and collaborators
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