NCT04285424

Brief Summary

The study aims to evaluate the safety and efficacy of fecal microbiota transplantation (FMT) for the treatment of steroid resistant graft-versus-host-disease (GVHD) of the gut. This strategy might offer a safe and effective therapeutic approach for these patients with a poor prognosis and limited therapeutic options.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
30

participants targeted

Target at P50-P75 for early_phase_1

Timeline
Completed

Started Mar 2020

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 20, 2020

Completed
6 days until next milestone

First Posted

Study publicly available on registry

February 26, 2020

Completed
4 days until next milestone

Study Start

First participant enrolled

March 1, 2020

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2021

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2022

Completed
Last Updated

March 2, 2020

Status Verified

February 1, 2020

Enrollment Period

1.8 years

First QC Date

February 20, 2020

Last Update Submit

February 27, 2020

Conditions

Stem Cell Transplant ComplicationsAcute Graft-Versus-Host DiseaseFecal Microbiota Transplantation

Outcome Measures

Primary Outcomes (1)

  • Gut acute Graft-versus-Host Disease (aGvHD) response.

    Participants will be evaluated within 7 days following transplantation for response to therapy.

    1 day to 7 days following FMT

Secondary Outcomes (5)

  • Non-serious adverse events

    1,3,5,7 days following FMTs

  • aGvHD severity

    1,3,5,7 days following FMT

  • Number of participants with infectious disorders

    1,3,5,7 days following FMT

  • Number of multidrug resistant bacteria in faeces

    1,3,5,7 days following FMT

  • Change in microbiota composition after FMT

    1,3,5,7 days months following FMT

Study Arms (1)

HSCT patients with acute steroid-resistant GI-related GVHD

EXPERIMENTAL

Patients will receive 500ml fecal microbiota which were sprayed evenly on the entire colon through colonscopy or duodenal nutrition tube injection which collected from one unrelated healthy donors. Patients receiving FMT treatment will be followed for at least 1,3,5,7 days.Stool, blood and colonic mucosa samples will be serially collected and tested (before pre-treatment, 1,3,5,7 days after FMT).

Biological: Fecal Microbiota Transplantation

Interventions

Fecal Microbiota TransplantationBIOLOGICAL

The fecal collection produced from a single healthy donor, unrelated to the patients

HSCT patients with acute steroid-resistant GI-related GVHD

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • \. Adults(ages are elder than 18 years and younger than 75 years) who developed gut acute Graft-versus-Host Disease(aGVHD) after allogeneic hematopoietic stem cell transplantation(HSCT) and were resistant to a first line therapy with steroids.
  • \. patients who were diagnosed as Stage 3 or 4 Gastro-intestinal Acute Graft-versus-Host(GI-aGVHD) with the symptoms such as diarrhea or abdominal pain.
  • \. Participants who accepted the FMT treatment. 4. Signature of informed and written consent by the subject.

You may not qualify if:

  • \. patients who were diagnosed as Stage 1 or 2 Gastro-intestinal Acute Graft-versus-Host(GI-aGVHD) 2. patients with unstable vital signs or severe cardiac and pulmonary disorder. 3. patients who were failure to cooperate endoscopy examination. 4. patients who were younger than 18 years or pregnant. 5. patients who were poor compliance to FMT treatment. 6. patients who were not able to give informed consent.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Affiliated Hospital to Academy of Military Medical Sciences

Beijing, Beijing Municipality, China

RECRUITING

MeSH Terms

Interventions

Fecal Microbiota Transplantation

Intervention Hierarchy (Ancestors)

Biological TherapyTherapeutics

Central Study Contacts

Min Min, MD

CONTACT

13426165452minmin823@sina.com

Yan Liu, MD

CONTACT

1391179828813911798288@163.com

Study Design

Study Type
interventional
Phase
early phase 1
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 20, 2020

First Posted

February 26, 2020

Study Start

March 1, 2020

Primary Completion

December 31, 2021

Study Completion

March 1, 2022

Last Updated

March 2, 2020

Record last verified: 2020-02

Locations

CN(1)