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Fecal Microbiota Transplantation in aGvHD After ASCT

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03819803
Recruitment Status : Recruiting
First Posted : January 29, 2019
Last Update Posted : April 6, 2022
Sponsor:
Information provided by (Responsible Party):
Medical University of Graz

Study Description
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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.


Condition or disease Intervention/treatment Phase
Graft Versus Host Disease in GI Tract Biological: Fecal microbiota transplantation Phase 3

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 15 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Intervention Model Description: Patients with acute gastrointestinal graft-versus-host disease refractory to steroid treatment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Fecal Microbiota Transplantation in Patients With Acute Gastrointestinal Graft-versus-host-disease After Allogeneic Stem Cell Transplantation
Actual Study Start Date : March 1, 2017
Estimated Primary Completion Date : March 1, 2024
Estimated Study Completion Date : December 31, 2024

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Bowel Movement

Arms and Interventions
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Arm Intervention/treatment
Experimental: Steroid refractory GI-aGvHD

Patients with GI-aGvHD not sufficiently responding to GvHD therapy with corticosteroids.

Intervention: Fecal microbiota transplantation

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


Outcome Measures
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Primary Outcome Measures :
  1. GI-aGvHD remission [ Time Frame: 90 days after first FMT ]
    Sustained remission of GI-aGvHD (CR or PR)


Secondary Outcome Measures :
  1. GI-aGvHD remission [ Time Frame: 45, 180 and 365 days after first FMT ]
    Sustained remission of GI-aGvHD (CR or PR)

  2. Disease-free survival [ Time Frame: 180 and 365 days after first FMT ]
    GI-aGvHD free survival

  3. Recurrence of GI-GvHD [ Time Frame: 365 days after remission ]
    Recurrence of GI-GvHD

  4. Patient survival [ Time Frame: 180 and 365 days after first FMT ]
    Survival (death or alive)

  5. SUSAR (Suspected Unexpected Serious Adverse Reaction) [ Time Frame: within 48 hours after a FMT ]
    Number of lethal or non-lethal SUSAR's

  6. SAE (Serious Adverse Event) [ Time Frame: within 48 hours after a FMT ]
    Number of lethal or non-lethal SAE's


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03819803


Contacts
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Contact: Walter DDr. Spindelboeck 0043 316 385 30195 walter.spindelboeck@medunigraz.at

Locations
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Austria
Division of Gastroenterology and Hepatology, Department of Internal Medicine, Medical University of Graz Recruiting
Graz, Styria, Austria, 8036
Contact: Walter Spindelboeck, DDr.    0043316385 ext 30195    walter.spindelboeck@medunigraz.at   
Sub-Investigator: Walter Spindelboeck, DDr.         
Principal Investigator: Peter Neumeister, Prof. Dr.         
Principal Investigator: Christoph Högenauer, Prof. Dr.         
Sponsors and Collaborators
Medical University of Graz
Investigators
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Principal Investigator: Peter Prof. Dr. Neumeister Department of Internal Medicine, Division of Hematology, Medical University of Graz
More Information
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Responsible Party: Medical University of Graz
ClinicalTrials.gov Identifier: NCT03819803    
Other Study ID Numbers: GI-aGvHD_01
First Posted: January 29, 2019    Key Record Dates
Last Update Posted: April 6, 2022
Last Verified: April 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Graft vs Host Disease
Immune System Diseases