Washed Microbiota Transplantation for Malnutrition After Nonphysiological Reconstruction of the Upper Gastrointestinal Tract

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorThe Second Hospital of Nanjing Medical University

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

62 Participants
are divided into 2 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