Fecal Microbiota Transplantation in aGvHD After ASCT

• ClinicalTrials.gov Identifier: NCT03819803
• Recruitment Status: Recruiting
• First Posted: January 29, 2019
• Last Update Posted: April 6, 2022
• Sponsor: Medical University of Graz
• Information provided by (Responsible Party): Medical University of Graz

Tracking Information

• First Submitted Date: September 14, 2018
• First Posted Date: January 29, 2019
• Last Update Posted Date: April 6, 2022
• Actual Study Start Date: March 1, 2017
• Estimated Primary Completion Date: March 1, 2024 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (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: Same as current

Current Secondary Outcome Measures (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: Same as current
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• 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

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: Interventional
• Study Phase: Phase 3

Study Design

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

• Condition: Graft Versus Host Disease in GI Tract

Intervention

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

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

Recruitment Information

• Recruitment Status: Recruiting
• Estimated Enrollment (submitted: January 24, 2019): 15
• Original Estimated Enrollment: Same as current
• Estimated Study Completion Date: December 31, 2024
• Estimated Primary Completion Date: March 1, 2024 (Final data collection date for primary outcome measure)

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

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 18 Years to 70 Years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Contacts

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

• Listed Location Countries: Austria

Administrative Information

• NCT Number: NCT03819803
• Other Study ID Numbers: 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

• Plan to Share IPD: No

• Current Responsible Party: Medical University of Graz
• Original Responsible Party: Same as current
• Current Study Sponsor: Medical University of Graz
• Original Study Sponsor: Same as current
• Collaborators: Not Provided

Investigators

• 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: April 2022