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

Shanghai Jiao Tong University

Status and phase: Completed; Phase 2

Conditions: Hematopoietic and Lymphoid Cell Neoplasm

Treatments: Biological: fecal microbiome transplantation

Study type: Interventional

Funder types: Other

Identifiers

NCT03812705

SHSYXY-FMT-GVHD-2018002

Details and patient eligibility

About

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.

Full 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.

Enrollment: 6 patients

Sex: All

Ages: 14 to 60 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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6 participants in 1 patient group

fecal microbiome transplantation

Experimental group

Description:

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.

Treatment:

Biological: fecal microbiome transplantation