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Fecal Microbiota Transplantation for Steroid Resistant/Dependent Acute GI GVHD

NCT03812705 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 6

Last updated 2024-04-23

No results posted yet for this study

Summary

The purpose of this study is to evaluate the efficacy and safety of fecal microbiome transplantation in patients with steroid resistant/dependent acute gastrointestinal graft-versus-host disease (GVHD). The patient will cease antibiotics treatment 1 day before FMT, and stop taking food 6 hours before FMT. Patients will be given Ondansetron intravenously 1 hour before FMT. Patients will be injected 200\~300 ml fecal microbiome fluid to left colon by Colonoscopy or duodenum through duodenal tube by gastroscopy. If patient's condition is stable or improved within 1 week, second FMT may be performed 1 week later, up to 4 times will be performed if patient response. If patient's condition is not improved after the second FMT, ceasing FMT.

Conditions

  • Hematopoietic and Lymphoid Cell Neoplasm

Interventions

BIOLOGICAL

fecal microbiome transplantation

1. Stop antibiotics treatment 1 day before fecal microbiome transplantation; 2. Fasting food 6 hours before fecal microbiome transplantation; 3. Give Ondansetron intravenously 1 hour before fecal microbiome transplantation for vomiting prevention; 4. Perform fecal microbiome transplantation under colonoscopy or gastroscopy; 5. Perform up to 4 times if patient response; 6. Stop if no response after twice fecal microbiome transplantation.

Sponsors & Collaborators

  • Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine

    lead OTHER

Principal Investigators

  • Liping Wan, MD · Shanghai Jiao Tong University Affiliated Shanghai General Hospiatal

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
14 Years
Max Age
60 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-12-13
Primary Completion
2024-03-30
Completion
2024-04-15

Countries

  • China

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03812705 on ClinicalTrials.gov