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Washed Microbiota Transplantation for the Treatment of Oncotherapy-Related Intestinal Complications

StatusRecruiting
PhaseNot applicable
Started
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Record status
This record was last updated March 6, 2025 (before its estimated May 2025 completion). Its status may not reflect the trial's current state.

Record History

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  1. Enrollment target: 40 to 200
    • Interventions: Washed Microbiota Transplantation (WMT) (Procedure) to Washed Microbiota Transplantation (WMT) (Other)
    • Study arms: 1 to 2
    v3
  2. Primary and study completion dates: Oct 2022 to May 2025
    • Start date: Oct 16, 2020 to Jan 26, 2021
    • Study description expanded, about 1 word
    v2
  3. 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  • Stopped: an ongoing trial was terminated, suspended or withdrawn.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.
Gut microbiota, known as "unrecognized organs", is closely related to the occurrence and development of tumors. Cancer is thought to occur secondary to local chronic inflammation. And some bacteria, such as Helicobacter pylori, also have direct genotoxicity, changing intracellular signaling pathways and thus causing abnormal cell growth. Systemic intestinal dysbiosis may lead to cancer, and fecal microbiota transplantation (FMT) can be a new weapon in anti-cancer treatment.Washed microbiota transplantation (WMT), a new stage of FMT, is based on the automatic microfiltration machine (GenFMTer, Nanjing, China) and the following repeated centrifugation plus suspension with support from specific facilities. The investigators conducted a prospective, one-arm, open-label study on the efficacy and safety of WMT in the treatment of oncotherapy-related complications. This study aimed to exploring the therapeutic potential of WMT in the treatment of oncotherapy-related intestinal complications and improving the quality of life of patients.
Trial Details
NCT Number NCT04721041
Lead Sponsor The Second Hospital of Nanjing Medical University
Conditions
(from sponsor)		 Intestinal Complications, Cancer
Related terms Neoplasms
Enrollment 200 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov