Track this trial free. DataLookout checks ClinicalTrials.gov daily and emails you which fields changed on NCT03516461 (status, enrollment, completion dates, endpoints, sites) when this record is updated. Free accounts track up to 5 trials.

Track this trial

Fecal Microbiota Transplantation for Radiation Enteritis

StatusUnknown
PhaseNot applicable
Started
View on ClinicalTrials.gov ↗
Record status
This record was last updated March 30, 2025 (before its estimated July 1, 2025 completion). Its status may not reflect the trial's current state.

Record History

See every version on ClinicalTrials.gov ↗

  1. Changed Registry marked status Unknown (sponsor has not verified the record since Sep 2024); last known: Recruiting
  2. Re-verified, no change to tracked fieldsv7
  3. Enrollment target: 30 to 70v6 Show 7 more changesShow less
    • Primary and study completion dates: Dec 2020 to Jul 1, 2025
    • Primary endpoint revised
    • Interventions: Fecal Microbiota Transplantation (FMT) (Procedure), Selective Microbiota Transplantation (SMT) (Procedure) to Fecal Microbiota Transplantation (FMT) (Procedure)
    • Secondary endpoints revised (2)
    • Study description shortened, about 35 words
    • Collaborator revised
    • Study title expanded, about 1 word
  4. Eligibility criteria shortened, about 5 wordsv5
  5. Primary completion date: Jan 2019 to Dec 2020v4 Show 7 more changesShow less
    • Interventions: Selective Microbiota Transplantation (mini-FMT) (Procedure) to Fecal Microbiota Transplantation (FMT) (Procedure), Selective Microbiota Transplantation (SMT) (Procedure)
    • Secondary endpoints: 1 to 2
    • Study description expanded, about 32 words
    • Publications: 6 to 12
    • Study arms: 1 to 2
    • Eligibility criteria expanded, about 1 word
    • Study title shortened, about 1 word
Show 2 earlier versionsHide 2 earlier versions
  1. Re-verified, no change to tracked fieldsv3
  2. Interventions: Synthetic Microbiota Transplantation (Procedure) to Selective Microbiota Transplantation (mini-FMT) (Procedure)v2 Show 4 more changesShow less
    • Secondary endpoints: details revised at 1 of 1 entry
    • Publications: 5 to 6
    • Study title revised
    • Study description expanded, about 1 word
  1. 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  • Stopped: an ongoing trial was terminated, suspended or withdrawn.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.
Radiation enteritis is one of the most feared complications after abdominal or pelvic radiation therapy.The gut microbiota is considered to constitute a "microbial organ" which has pivotal roles in the intestinal diseases and body metabolism. Evidence from animal studies demonstrated the link between intestinal bacteria and radiation enteritis. This clinical trial aims to evaluate the efficacy and safety of fecal microbiota transplantation (FMT) for radiation enteritis.
Trial Details
NCT Number NCT03516461
Lead Sponsor The Second Hospital of Nanjing Medical University
Collaborators: Jiangxi Provincial Cancer Hospital
Conditions
(from sponsor)		 Radiation Enteritis
Enrollment 70 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov