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Fecal Microbiota Transplantation in aGvHD After ASCT

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ClinicalTrials.gov Identifier: NCT03819803
Recruitment Status : Recruiting
First Posted : January 29, 2019
Last Update Posted : January 29, 2019
Sponsor:
Information provided by (Responsible Party):
Medical University of Graz

Tracking Information
First Submitted Date  ICMJE September 14, 2018
First Posted Date  ICMJE January 29, 2019
Last Update Posted Date January 29, 2019
Actual Study Start Date  ICMJE March 1, 2017
Estimated Primary Completion Date March 1, 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: January 24, 2019)
GI-aGvHD remission [ Time Frame: 90 days after first FMT ]
Sustained remission of GI-aGvHD (CR or PR)
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE
 (submitted: January 24, 2019)
  • GI-aGvHD remission [ Time Frame: 45, 180 and 365 days after first FMT ]
    Sustained remission of GI-aGvHD (CR or PR)
  • Disease-free survival [ Time Frame: 180 and 365 days after first FMT ]
    GI-aGvHD free survival
  • Recurrence of GI-GvHD [ Time Frame: 365 days after remission ]
    Recurrence of GI-GvHD
  • Patient survival [ Time Frame: 180 and 365 days after first FMT ]
    Survival (death or alive)
  • SUSAR (Suspected Unexpected Serious Adverse Reaction) [ Time Frame: within 48 hours after a FMT ]
    Number of lethal or non-lethal SUSAR's
  • SAE (Serious Adverse Event) [ Time Frame: within 48 hours after a FMT ]
    Number of lethal or non-lethal SAE's
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Fecal Microbiota Transplantation in aGvHD After ASCT
Official Title  ICMJE Fecal Microbiota Transplantation in Patients With Acute Gastrointestinal Graft-versus-host-disease After Allogeneic Stem Cell Transplantation
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.

Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE 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
Condition  ICMJE Graft Versus Host Disease in GI Tract
Intervention  ICMJE 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
Study Arms  ICMJE Experimental: Steroid refractory GI-aGvHD

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

Intervention: Fecal microbiota transplantation

Intervention: Biological: Fecal microbiota transplantation
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: January 24, 2019)
15
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE December 31, 2020
Estimated Primary Completion Date March 1, 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 70 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Walter DDr. Spindelboeck 0043 316 385 30195 walter.spindelboeck@medunigraz.at
Listed Location Countries  ICMJE Austria
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03819803
Other Study ID Numbers  ICMJE GI-aGvHD_01
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Medical University of Graz
Study Sponsor  ICMJE Medical University of Graz
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Peter Prof. Dr. Neumeister Department of Internal Medicine, Division of Hematology, Medical University of Graz
PRS Account Medical University of Graz
Verification Date January 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP