Fecal Microbiota Transplantation for Steroid Resistant/Dependent Acute GI GVHD

NCT ID: NCT03812705

Last Updated: 2024-04-23

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 6 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-12-13
• Study Completion Date: 2024-04-15

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.

Conditions

Hematopoietic and Lymphoid Cell Neoplasm

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

fecal microbiome transplantation

Intervention Type: BIOLOGICAL

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.

Interventions

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.

Intervention Type: BIOLOGICAL

Eligibility 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.

• Minimum Eligible Age: 14 Years
• Maximum Eligible Age: 60 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine

OTHER

Sponsor Role: lead

Responsible Party

Liping Wan

Chief physician

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Liping Wan, MD

Role: PRINCIPAL_INVESTIGATOR

Shanghai Jiao Tong University Affiliated Shanghai General Hospiatal

Locations

Shanghai Jiao Tong University Affilated First People's Hospital

Shanghai, Shanghai Municipality, China

Shanghai Jiao Tong University Affilated Shanghai General Hospital

Shanghai, Shanghai Municipality, China

Countries

China

Other Identifiers

SHSYXY-FMT-GVHD-2018002

Identifier Type: -

Identifier Source: org_study_id