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Fecal Microbiota Transplantation in aGvHD After ASCT

Primary Purpose

Graft Versus Host Disease in GI Tract

Status

Recruiting

Phase

Phase 3

Locations

Austria

Study Type

Interventional

Intervention

Fecal microbiota transplantation

About this trial

This is an interventional treatment trial for Graft Versus Host Disease in GI Tract

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

first episode of histologically confirmed, steroid-refractory GI-aGvHD
reduced bacterial diversity in the patient´s stool microbiota evidenced by 16s-rDNA measurement
eligibility for repeated colonoscopic procedures
informed consent

Exclusion Criteria:

complications during a previous colonoscopy
recurrent episode of GI-aGvHD
lacking cardiopulmonary fitness for repeated colonoscopic procedures
septic infection
acute extraintestinal organ failure (excluding bone marrow)
mechanical ileus

Sites / Locations

Division of Gastroenterology and Hepatology, Department of Internal Medicine, Medical University of GrazRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Steroid refractory GI-aGvHD

Arm Description

Patients with GI-aGvHD not sufficiently responding to GvHD therapy with corticosteroids. Intervention: Fecal microbiota transplantation

Outcomes

Primary Outcome Measures

GI-aGvHD remission

Sustained remission of GI-aGvHD (CR or PR)

Secondary Outcome Measures

GI-aGvHD remission

Sustained remission of GI-aGvHD (CR or PR)

Disease-free survival

GI-aGvHD free survival

Recurrence of GI-GvHD

Patient survival

Survival (death or alive)

SUSAR (Suspected Unexpected Serious Adverse Reaction)

Number of lethal or non-lethal SUSAR's

SAE (Serious Adverse Event)

Number of lethal or non-lethal SAE's

Full Information

NCT ID

NCT03819803

First Posted

September 14, 2018

Last Updated

April 5, 2022

Sponsor

Medical University of Graz

1. Study Identification

Unique Protocol Identification Number

NCT03819803

Brief Title

Fecal Microbiota Transplantation in aGvHD After ASCT

Official Title

Fecal Microbiota Transplantation in Patients With Acute Gastrointestinal Graft-versus-host-disease After Allogeneic Stem Cell Transplantation

Study Type

Interventional

2. Study Status

Record Verification Date

April 2022

Overall Recruitment Status

Recruiting

Study Start Date

March 1, 2017 (Actual)

Primary Completion Date

March 1, 2024 (Anticipated)

Study Completion Date

December 31, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Medical University of Graz

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

Brief Summary

Acute graft-versus-host-disease (aGvHD) is a typical complication after allogeneic hematopoetic stem cell transplantation (ASCT). About 30-60% of patients after ASCT are affected by aGvHD, which constitutes a relevant burden of morbidity and mortality in these patients. Fecal microbiota transplantation (FMT) is a therapeutic concept to treat intestinal dysbiosis of various origin by infusion of the stool microbiota of a healthy donor into the gastrointestinal tract (GI) of a patient. FMT can be performed endoscopically by colonoscopic deployment of the donor microbiota into the patient´s caecum and terminal ileum. Patients with gastrointestinal aGvHD (GI-aGvHD) are known to comprise a significant dysbiotic colonic microbiota that can be attenuated by FMT.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Graft Versus Host Disease in GI Tract

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 3

Interventional Study Model

Single Group Assignment

Model Description

Patients with acute gastrointestinal graft-versus-host disease refractory to steroid treatment

Masking

None (Open Label)

Allocation

N/A

Enrollment

15 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Steroid refractory GI-aGvHD

Arm Type

Experimental

Arm Description

Patients with GI-aGvHD not sufficiently responding to GvHD therapy with corticosteroids. Intervention: Fecal microbiota transplantation

Intervention Type

Biological

Intervention Name(s)

Fecal microbiota transplantation

Intervention Description

200 ml of a tested stool suspension of a healthy donor is instilled into the patient´s caecum or terminal ileum

Primary Outcome Measure Information:

Title

GI-aGvHD remission

Description

Sustained remission of GI-aGvHD (CR or PR)

Time Frame

90 days after first FMT

Secondary Outcome Measure Information:

Title

GI-aGvHD remission

Description

Sustained remission of GI-aGvHD (CR or PR)

Time Frame

45, 180 and 365 days after first FMT

Title

Disease-free survival

Description

GI-aGvHD free survival

Time Frame

180 and 365 days after first FMT

Title

Recurrence of GI-GvHD

Description

Recurrence of GI-GvHD

Time Frame

365 days after remission

Title

Patient survival

Description

Survival (death or alive)

Time Frame

180 and 365 days after first FMT

Title

SUSAR (Suspected Unexpected Serious Adverse Reaction)

Description

Number of lethal or non-lethal SUSAR's

Time Frame

within 48 hours after a FMT

Title

SAE (Serious Adverse Event)

Description

Number of lethal or non-lethal SAE's

Time Frame

within 48 hours after a FMT

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

70 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: first episode of histologically confirmed, steroid-refractory GI-aGvHD reduced bacterial diversity in the patient´s stool microbiota evidenced by 16s-rDNA measurement eligibility for repeated colonoscopic procedures informed consent Exclusion Criteria: complications during a previous colonoscopy recurrent episode of GI-aGvHD lacking cardiopulmonary fitness for repeated colonoscopic procedures septic infection acute extraintestinal organ failure (excluding bone marrow) mechanical ileus

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Walter DDr. Spindelboeck

Phone

0043 316 385 30195

walter.spindelboeck@medunigraz.at

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Peter Prof. Dr. Neumeister

Organizational Affiliation

Department of Internal Medicine, Division of Hematology, Medical University of Graz

Official's Role

Principal Investigator

Facility Information:

Facility Name

Division of Gastroenterology and Hepatology, Department of Internal Medicine, Medical University of Graz

City

Graz

State/Province

Styria

ZIP/Postal Code

8036

Country

Austria

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Walter Spindelboeck, DDr.

Phone

0043316385

Ext

30195

walter.spindelboeck@medunigraz.at

First Name & Middle Initial & Last Name & Degree

Walter Spindelboeck, DDr.

First Name & Middle Initial & Last Name & Degree

Peter Neumeister, Prof. Dr.

First Name & Middle Initial & Last Name & Degree

Christoph Högenauer, Prof. Dr.

12. IPD Sharing Statement

Plan to Share IPD

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Fecal Microbiota Transplantation in aGvHD After ASCT

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