NCT03214289

Fecal Microbiota Transplantation for Steroid Resistant and Steroid Dependent Gut Acute Graft Versus Host Disease

Status unknown Phase 1 Last updated 9 April 2018

What this trial tests

Phase 1 trial testing Fecal Microbiota Transplantation in Stem Cell Transplant Complications in 4 participants. Status unknown.

Timeline

12 July 2017

Primary endpoint
20 July 2019

20 December 2019

Quick facts

Lead sponsor	Sheba Medical Center
Phase	Phase 1
Status	Status unknown
Study type	INTERVENTIONAL
Allocation	na
Design	single group
Masking	none
Primary purpose	treatment
Enrollment	4
Start date	12 July 2017
Primary completion	20 July 2019
Estimated completion	20 December 2019
Sites	1 location across Israel

Drugs / interventions tested

• Fecal Microbiota Transplantation — full drug profile →

Conditions studied

• Stem Cell Transplant Complications — all drugs for Stem Cell Transplant Complications →
• Graft Versus Host Disease, Acute — all drugs for Graft Versus Host Disease, Acute →
• Fecal Microbiota Transplantation — all drugs for Fecal Microbiota Transplantation →

Sponsor

Sheba Medical Center

Who can join

Adults 18 to 75, any sex, with Stem Cell Transplant Complications or Graft Versus Host Disease, Acute. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

The investigators hypothesize that perturbations in the intestinal microbiota following allogeneic hematopoietic stem cell transplantation (HSCT) are essential for the development and propagation of acute graft-versus-host disease. Therefore, modification of HSCT recipients' gut microbiota using fecal transplantation from a healthy donor could be used to treat gut acute GVHD.

The study evaluates safety and feasibility of fecal microbiota transplantation with frozen capsules from healthy donors for the treatment of steroid resistant or steroid dependent acute graft-versus-host disease of the gut.

Publications & conference data

8 peer-reviewed publications reference this trial (live from Europe PMC):

1. The Influence of the Gut Microbiome on Cancer, Immunity, and Cancer Immunotherapy.
   Gopalakrishnan V, Helmink BA, Spencer CN, Reuben A, et al · · 2018 · cited 1012× · PMID 29634945 · DOI 10.1016/j.ccell.2018.03.015
2. Modulating the microbiome to improve therapeutic response in cancer.
   McQuade JL, Daniel CR, Helmink BA, Wargo JA. · · 2019 · cited 283× · PMID 30712808 · DOI 10.1016/s1470-2045(18)30952-5
3. Fecal microbiota transplantation beyond Clostridioides difficile infections.
   Wortelboer K, Nieuwdorp M, Herrema H. · · 2019 · cited 111× · PMID 31201141 · DOI 10.1016/j.ebiom.2019.05.066
4. Treatment and unmet needs in steroid-refractory acute graft-versus-host disease.
   Malard F, Huang XJ, Sim JPY. · · 2020 · cited 98× · PMID 32242050 · DOI 10.1038/s41375-020-0804-2
5. The Microbiome and Hematopoietic Cell Transplantation: Past, Present, and Future.
   Andermann TM, Peled JU, Ho C, Reddy P, et al · · 2018 · cited 84× · PMID 29471034 · DOI 10.1016/j.bbmt.2018.02.009
6. Long-term impact of fecal transplantation in healthy volunteers.
   Goloshchapov OV, Olekhnovich EI, Sidorenko SV, Moiseev IS, et al · · 2019 · cited 59× · PMID 31888470 · DOI 10.1186/s12866-019-1689-y
7. Current approaches to prevent and treat GVHD after allogeneic stem cell transplantation.
   Hamilton BK. · · 2018 · cited 52× · PMID 30504315 · DOI 10.1182/asheducation-2018.1.228
8. Intestinal Microbiota Influence Immune Tolerance Post Allogeneic Hematopoietic Cell Transplantation and Intestinal GVHD.
   Köhler N, Zeiser R. · · 2018 · cited 39× · PMID 30705680 · DOI 10.3389/fimmu.2018.03179