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Trial record 27 of 89 for:    Recruiting Studies | fecal microbiota transplantation

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

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.

Condition or disease Intervention/treatment Phase
Hematopoietic and Lymphoid Cell Neoplasm Biological: fecal microbiome transplantation Phase 2

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 30 participants
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
Official Title: Fecal Microbiota Transplantation for the Treatment of Steroid Resistant/Dependent Acute Gastrointestinal Graft Versus Host Disease
Actual Study Start Date : December 13, 2018
Estimated Primary Completion Date : December 31, 2021
Estimated Study Completion Date : December 31, 2022

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Bowel Movement

Arm Intervention/treatment
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.
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.




Primary Outcome Measures :
  1. Response rate [ Time Frame: 12 weeks within FMT ]
    Response rate of acute gastrointestinal GVHD after FMT, including complete response and partial response.


Secondary Outcome Measures :
  1. Time to response [ Time Frame: 12 weeks within FMT ]
    Time to response of acute gastrointestinal GVHD

  2. Duration of response [ Time Frame: 12 weeks within FMT ]
    Duration of response of acute gastrointestinal GVHD



Information from the National Library of Medicine

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Ages Eligible for Study:   14 Years to 60 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03812705


Contacts
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Contact: Liping Wan, MD 862137798075 wanliping924@hotmail.com
Contact: Kun Zhou, MD 862137798987 zhkzhw@163.com

Locations
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China, Shanghai
Shanghai Jiao Tong University Affilated First People's Hospital Recruiting
Shanghai, Shanghai, China, 200080
Contact: Xingpeng Wang, M.D, Ph.D    63069298    sfph_edu2@163.com   
Contact: Yanhong Zhu, M.S    63240090 ext 6213    sfph_edu2@shmu.edu.cn   
Sub-Investigator: Liping Wan, M.D., Ph.D.         
Shanghai Jiao Tong University Affilated Shanghai General Hospital Recruiting
Shanghai, Shanghai, China, 200080
Contact: Xingpeng Wang, M.D, Ph.D    63069298    sfph_edu2@163.com   
Contact: Yanhong Zhu, M.S    63240090 ext 6213    sfph_edu2@shmu.edu.cn   
Principal Investigator: Liping Wan, M.D., Ph.D.         
Sponsors and Collaborators
Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine
Investigators
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Principal Investigator: Liping Wan, MD Shanghai Jiao Tong University Affiliated Shanghai General Hospiatal

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Responsible Party: Liping Wan, Chief physician, Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine
ClinicalTrials.gov Identifier: NCT03812705     History of Changes
Other Study ID Numbers: SHSYXY-FMT-GVHD-2018002
First Posted: January 23, 2019    Key Record Dates
Last Update Posted: January 23, 2019
Last Verified: January 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Liping Wan, Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine:
allogeneic hematopoeitic stem cell transplantation
acute gastrointestinal graft versus host disease
fecal microbiome transplantation
Additional relevant MeSH terms:
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Hematologic Neoplasms
Neoplasms by Site
Neoplasms
Hematologic Diseases