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

StatusRecruiting
PhaseNot applicable
Started
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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.

Record History

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  1. Trial status: Not Yet Recruiting to Recruiting
    • Primary endpoints: 2 to 3
    • Study site revised
    v5
  2. Primary endpoints: 3 to 2v4 Show 5 more changesShow less
    • Start date: Oct 12, 2024 to Oct 20, 2024
    • Secondary endpoints: 15 to 17
    • Collaborators: 11 to 27
    • Eligibility criteria expanded, about 5 words
    • Study description shortened, about 1 word
  3. Primary completion date: Jun 1, 2023 to Oct 31, 2025v3 Show 9 more changesShow less
    • Start date: Jul 1, 2022 to Oct 12, 2024
    • Primary endpoints: 2 to 3
    • Enrollment target: 56 to 62
    • Study completion date: Jul 1, 2023 to Oct 31, 2025
    • Eligibility criteria expanded, about 55 words
    • Secondary endpoints expanded, about 88 words
    • Study description expanded, about 15 words
    • Collaborators: 3 to 11
    • Study title expanded, about 3 words
  4. Re-verified, no change to tracked fieldsv2
  5. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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.
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
(from sponsor)		 Malnutrition, Gastroenterostomy
Related terms Cachexia, Malnutrition
Enrollment 62 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov