Fecal Microbiota Transplantation for Steroid Resistant/Dependent Acute GI GVHD

NCT03812705 | Completed Phase 2 DMC

• 1 other identifier: SHSYXY-FMT-GVHD-2018002
• Study Type: interventional
• Target: 6
• Locations: 1 country
• Sites: 2

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.

Conditions

Hematopoietic and Lymphoid Cell Neoplasm

Keywords

allogeneic hematopoeitic stem cell transplantation; acute gastrointestinal graft versus host disease; fecal microbiome transplantation

Outcome Measures

Primary Outcomes (1)

• Response rate

  Response rate of acute gastrointestinal GVHD after FMT, including complete response and partial response.

  12 weeks within FMT

Secondary Outcomes (2)

• Time to response

  12 weeks within FMT

• Duration of response

  12 weeks within FMT

Study Arms (1)

fecal microbiome transplantation

EXPERIMENTAL

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

Interventions

fecal microbiome transplantation 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.

fecal microbiome transplantation

Eligibility Criteria

• Age: 14 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• Age\>= 14 yrs ≤60 yrs.
• Diagnosed with hematological diseases.
• Recipients of allogeneic peripheral blood stem cell transplantation.
• 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.
• Eastern Cooperative Oncology Group (ECOG) score ≤2;
• Signed consent form.

You may not qualify if:

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

Sponsors & Collaborators

• Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine: lead

Study Sites (2)

Shanghai Jiao Tong University Affilated First People's Hospital

Shanghai, Shanghai Municipality, 200080, China

Location

Shanghai Jiao Tong University Affilated Shanghai General Hospital

Shanghai, Shanghai Municipality, 200080, China

Location

MeSH Terms

Conditions

Hematologic Neoplasms

Interventions

Fecal Microbiota Transplantation

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Hematologic Diseases; Hemic and Lymphatic Diseases

Intervention Hierarchy (Ancestors)

Biological Therapy; Therapeutics

Study Officials

• Liping Wan, MD

  Shanghai Jiao Tong University Affiliated Shanghai General Hospiatal

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Chief physician

Model Details: fecal microbiome transplantation for patients with steroid resistant/dependent acute gastroinstestinal graft versus host disease

Study Record Dates

• First Submitted: January 19, 2019
• First Posted: January 23, 2019
• Study Start: December 13, 2018
• Primary Completion: March 30, 2024
• Study Completion: April 15, 2024
• Last Updated: April 23, 2024

Record last verified: 2024-04

Locations

CN (2)