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Fecal Microbiota Transplantation for Steroid Resistant/Dependent Acute GI GVHD (FEMITGIGVHD)

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ClinicalTrials.gov Identifier: NCT03812705
Recruitment Status : Recruiting
First Posted : January 23, 2019
Last Update Posted : January 23, 2019
Sponsor:
Information provided by (Responsible Party):
Liping Wan, Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine

Tracking Information
First Submitted Date  ICMJE January 19, 2019
First Posted Date  ICMJE January 23, 2019
Last Update Posted Date January 23, 2019
Actual Study Start Date  ICMJE December 13, 2018
Estimated Primary Completion Date December 31, 2021   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: January 19, 2019)
Response rate [ Time Frame: 12 weeks within FMT ]
Response rate of acute gastrointestinal GVHD after FMT, including complete response and partial response.
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE
 (submitted: January 19, 2019)
  • Time to response [ Time Frame: 12 weeks within FMT ]
    Time to response of acute gastrointestinal GVHD
  • Duration of response [ Time Frame: 12 weeks within FMT ]
    Duration of response of acute gastrointestinal GVHD
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Fecal Microbiota Transplantation for Steroid Resistant/Dependent Acute GI GVHD
Official Title  ICMJE Fecal Microbiota Transplantation for the Treatment of Steroid Resistant/Dependent Acute Gastrointestinal Graft Versus Host Disease
Brief 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.
Detailed Description

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).

Inclusion criteria:

  1. Age>= 14 yrs ≤60 yrs.
  2. Diagnosed with hematological diseases.
  3. Recipients of allogeneic peripheral blood stem cell transplantation.
  4. Steroid resistant/dependent acute intestinal graft-versus-host disease (GVHD) within 100 days post-transplantation. The definition of steroid resistant/dependent acute intestinal GVHD is progression within 3 days of starting treatment or an incomplete response by 7 days or recurrence after initial dose reduction.
  5. ECOG score ≤2;
  6. signed consent form.

Exclusion criteria:

  1. Complicated with uncontrolled severe infection except intestine and colon.
  2. High risk of hemorrhage, dysfunction of coagulation, active gastrointestinal hemorrhage;
  3. Absolute neutrophil count (ANC) <0.5×10e9/L or platelet count (PLT) < 20×10e9/L
  4. Severe organ dysfunction, including heart failure, respiratory failure, renal failure, epilepsy or central nervous system dysfunction.
  5. Participating other clinical trials.
  6. Pregnant women.

Treatment:

  1. Stop antibiotics treatment 1 day before FMT;
  2. Fasting food 6 hours before FMT;
  3. Give Ondansetron intravenously 1 hour before FMT for vomiting prevention;
  4. Injection of 200~300 ml fecal microbiome fluid to left colon by Colonoscopy or duodenum through duodenum tube by gastroscopy;
  5. 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;
  6. If patient's condition is not improved after the second FMT, stop FMT.

Major endpoint Response rate of acute gastrointestinal GVHD with 12 weeks after FMT, including complete response and partial response.

Minor endpoints:

  1. Time to response of acute gastrointestinal GVHD;
  2. Duration of response of acute gastrointestinal GVHD.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Intervention Model: Single Group Assignment
Intervention Model Description:
fecal microbiome transplantation for patients with steroid resistant/dependent acute gastroinstestinal graft versus host disease
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Hematopoietic and Lymphoid Cell Neoplasm
Intervention  ICMJE 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.
Study Arms  ICMJE Experimental: fecal microbiome transplantation
  1. Perform fecal microbiome transplantation to patient under colonoscopy or gastroscopy: injection of 200~300 ml fecal microbiome fluid as fecal microbiome transplantation to left colon by Colonoscopy or duodenum through duodenum tube by gastroscopy;
  2. If patient's condition is stable or improved within 1 week, second fecal microbiome transplantation may be performed 1 week later, up to 4 times will be performed if patient response;
  3. If patient's condition is not improved after the second fecal microbiome transplantation, stop fecal microbiome transplantation.
Intervention: Biological: fecal microbiome transplantation
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: January 19, 2019)
30
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE December 31, 2022
Estimated Primary Completion Date December 31, 2021   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  1. Age>= 14 yrs ≤60 yrs.
  2. Diagnosed with hematological diseases.
  3. Recipients of allogeneic peripheral blood stem cell transplantation.
  4. Steroid resistant/dependent acute intestinal graft-versus-host disease (GVHD) within 100 days post-transplantation. The definition of steroid resistant/dependent acute intestinal GVHD is progression within 3 days of starting treatment or an incomplete response by 7 days or recurrence after initial dose reduction.
  5. Eastern Cooperative Oncology Group (ECOG) score ≤2;
  6. Signed consent form.

Exclusion Criteria:

  1. Complicated with uncontrolled severe infection except intestine and colon.
  2. High risk of hemorrhage, dysfunction of coagulation, active gastrointestinal hemorrhage;
  3. Absolute neutrophil count (ANC) <0.5×10e9/L or platelet count (PLT) < 20×10e9/L
  4. Severe organ dysfunction, including heart failure, respiratory failure, renal failure, epilepsy or central nervous system dysfunction.
  5. Participating other clinical trials.
  6. Pregnant women.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 14 Years to 60 Years   (Child, Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Liping Wan, MD 862137798075 wanliping924@hotmail.com
Contact: Kun Zhou, MD 862137798987 zhkzhw@163.com
Listed Location Countries  ICMJE China
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03812705
Other Study ID Numbers  ICMJE SHSYXY-FMT-GVHD-2018002
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Liping Wan, Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine
Study Sponsor  ICMJE Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Liping Wan, MD Shanghai Jiao Tong University Affiliated Shanghai General Hospiatal
PRS Account Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine
Verification Date January 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP