Clinical Trial

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

Recruiting
View on ClinicalTrials.gov →
Record status
This record was last updated July 10, 2025 (before its estimated October 31, 2025 completion). Its status may not reflect the trial's current state.
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.
Protocol Amendment History 4 amendments
This ClinicalTrials.gov record has been amended 4 times since 2022-06-26; most recent amendment 2025-07-06.
Status change: Not Yet Recruiting → Recruiting 2025-07-06
Trial Details
NCT Number NCT05439135
Lead Sponsor The Second Hospital of Nanjing Medical University
Collaborators: The First Affiliated Hospital of Guangdong Pharmaceutical University, Nanjing Medical University, Wuxi No. 2 People's Hospital, Jiangxi University of Chinese Medicine Affiliated Hospital, Hubei Hospital of Traditional Chinese Medicine, The Affiliated Hospital Of Southwest Medical University, Tang-Du Hospital, Huzhou Central Hospital, West China Fourth Hospital, The Affiliated People's Hospital of Ningbo University, Guangzhou First People Hospital of Guangzhou Medical University, The First Affiliated Hospital of Anhui University of Chinese Medicine, Beijing Rectum Hospital, Dazhou Central Hospital, The Second Affiliated Hospital of Dalian Medical University, Second Affiliated Hospital of Guangzhou Medical University, PLA No. 901 Hospital of the Joint Support Force, YI'AN PEOPLE'S HOSPITAL, Hunan Aerospace Hospital, Jiamusi City Hospital of Traditional Chinese Medicine, The First People's Hospital of Kunshan, LanZhou University, Jingxing xian yiyuan, TAIHE country people's hospital, Tailai County People's Hospital, Armed Police Characteristic Medical Center, First Affiliated Hospital Xi'an Jiaotong University
Conditions Malnutrition, Gastroenterostomy
Enrollment 62 participants
Start Date 2024-10-20
Primary Completion 2025-10-31 (estimated)
Study Completion 2025-10-31 (estimated)
Updated on ClinicalTrials.gov 2025-07-10