Fecal Microbiota Transplantation for Steroid Resistant/Dependent Acute GI GVHD

Hematopoietic and Lymphoid Cell Neoplasm Clinical Trial

— FEMITGIGVHD  

Official title:

Fecal Microbiota Transplantation for the Treatment of Steroid Resistant/Dependent Acute Gastrointestinal Graft Versus Host Disease

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03812705
• Other study ID #: SHSYXY-FMT-GVHD-2018002
• Status: Completed
• Phase: Phase 2
• Start date: December 13, 2018
• Est. completion date: April 15, 2024

Study information

• Verified date: April 2024
• Source: Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 6
• Est. completion date: April 15, 2024
• Est. primary completion date: March 30, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 14 Years to 60 Years

Eligibility

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.

Related Conditions & MeSH terms

• Hematologic Neoplasms
• Hematopoietic and Lymphoid Cell Neoplasm

Intervention

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

Locations

Country	Name	City	State
China	Shanghai Jiao Tong University Affilated First People's Hospital	Shanghai	Shanghai
China	Shanghai Jiao Tong University Affilated Shanghai General Hospital	Shanghai	Shanghai

Sponsors (1)

Lead Sponsor	Collaborator
Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Response rate	Response rate of acute gastrointestinal GVHD after FMT, including complete response and partial response.	12 weeks within FMT
Secondary	Time to response	Time to response of acute gastrointestinal GVHD	12 weeks within FMT
Secondary	Duration of response	Duration of response of acute gastrointestinal GVHD	12 weeks within FMT