Fecal Microbiota Transplantation in aGvHD After ASCT

• Sponsor: Medical University of Graz (Other)
• Overall Status: Recruiting
• CT.gov ID: NCT03819803
• Collaborator: (none)
• Enrollment: 15
• Location: 1
• Arm: 1
• Anticipated Duration (Months): 94
• Patients Per Site Per Month: 0.2

Study Details

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.

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

Study Design

• Study Type: Interventional
• Anticipated 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 treatmentPatients 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: Mar 1, 2017
• Anticipated Primary Completion Date: Mar 1, 2024
• Anticipated Study Completion Date: Dec 31, 2024

Arms and Interventions

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

Primary Outcome Measures

1. GI-aGvHD remission [90 days after first FMT]

   Sustained remission of GI-aGvHD (CR or PR)

Secondary Outcome Measures

1. GI-aGvHD remission [45, 180 and 365 days after first FMT]

   Sustained remission of GI-aGvHD (CR or PR)

2. Disease-free survival [180 and 365 days after first FMT]

   GI-aGvHD free survival

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

   Recurrence of GI-GvHD

4. Patient survival [180 and 365 days after first FMT]

   Survival (death or alive)

5. SUSAR (Suspected Unexpected Serious Adverse Reaction) [within 48 hours after a FMT]

   Number of lethal or non-lethal SUSAR's

6. SAE (Serious Adverse Event) [within 48 hours after a FMT]

   Number of lethal or non-lethal SAE's

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 70 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Locations

	Site	City	State	Country	Postal Code
1	Division of Gastroenterology and Hepatology, Department of Internal Medicine, Medical University of Graz	Graz	Styria	Austria	8036

Sponsors and Collaborators

• Medical University of Graz

Investigators

• Principal Investigator: Peter Prof. Dr. Neumeister, Department of Internal Medicine, Division of Hematology, Medical University of Graz

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Medical University of Graz
• ClinicalTrials.gov Identifier: NCT03819803
• Other Study ID Numbers: GI-aGvHD_01
• First Posted: Jan 29, 2019
• Last Update Posted: Apr 6, 2022
• Last Verified: Apr 1, 2022

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Graft vs Host Disease

Study Results

No Results Posted as of Apr 6, 2022