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

Summary

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.

Conditions

• Malnutrition
• Gastroenterostomy

Interventions

OTHER

washed microbiota transplantation

Each 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.

Sponsors & Collaborators

• The First Affiliated Hospital of Guangdong Pharmaceutical University

  collaborator OTHER

• Nanjing Medical University

  collaborator OTHER

• Wuxi No. 2 People's Hospital

  collaborator OTHER

• Jiangxi University of Chinese Medicine Affiliated Hospital

  collaborator UNKNOWN

• Hubei Hospital of Traditional Chinese Medicine

  collaborator OTHER

• The Affiliated Hospital Of Southwest Medical University

  collaborator OTHER

• Tang-Du Hospital

  collaborator OTHER

• Huzhou Central Hospital

  collaborator OTHER

• West China Forth University Hospital，Sichuan University

  collaborator UNKNOWN

• The Affiliated People's hospital of Ningbo Univercity

  collaborator OTHER

• Guangzhou First People Hospital of Guangzhou Medical University

  collaborator UNKNOWN

• The First Affiliated Hospital of Anhui University of Chinese Medicine

  collaborator OTHER

• Beijing Rectum Hospital

  collaborator UNKNOWN

• Dazhou Central Hospital

  collaborator OTHER

• The Second Affiliated Hospital of Dalian Medical University

  collaborator OTHER

• Second Affiliated Hospital of Guangzhou Medical University

  collaborator OTHER

• The 901th Hospital of Joint Logistics Support Force of Chinese People's Liberation Army

  collaborator UNKNOWN

• YI'AN PEOPLE'S HOSPITAL

  collaborator UNKNOWN

• Hunan Aerospace Hospital

  collaborator UNKNOWN

• Jiamusi City Hospital of Traditional Chinese Medicine

  collaborator UNKNOWN

• The First People's Hospital of Kunshan

  collaborator OTHER

• LanZhou University

  collaborator OTHER

• Jingxing xian yiyuan

  collaborator UNKNOWN

• TAIHE country people's hospital

  collaborator UNKNOWN

• Tailai County People's Hospital

  collaborator UNKNOWN

• Armed Police Characteristic Medical Center

  collaborator UNKNOWN

• First Affiliated Hospital Xi'an Jiaotong University

  collaborator OTHER

• The Second Hospital of Nanjing Medical University

  lead OTHER

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2024-10-20

Primary Completion

2025-10-31

Completion

2025-10-31

Countries

• China

Study Locations