NCT04285424

FMT for Steroid Resistant Gut Acute GVHD

Status unknown EARLY_PHASE1 Last updated 2 March 2020

What this trial tests

EARLY_PHASE1 trial testing Fecal Microbiota Transplantation in Stem Cell Transplant Complications in 30 participants. Status unknown.

Timeline

1 March 2020

Primary endpoint
31 December 2021

1 March 2022

Quick facts

Lead sponsor	Affiliated Hospital to Academy of Military Medical Sciences
Phase	EARLY_PHASE1
Status	Status unknown
Study type	INTERVENTIONAL
Allocation	na
Design	single group
Masking	none
Primary purpose	treatment
Enrollment	30
Start date	1 March 2020
Primary completion	31 December 2021
Estimated completion	1 March 2022
Sites	1 location across China

Drugs / interventions tested

• Fecal Microbiota Transplantation — full drug profile →

Conditions studied

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

Sponsor

Affiliated Hospital to Academy of Military Medical Sciences

Who can join

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

Sponsor's own description

The study aims to evaluate the safety and efficacy of fecal microbiota transplantation (FMT) for the treatment of steroid resistant graft-versus-host-disease (GVHD) of the gut. This strategy might offer a safe and effective therapeutic approach for these patients with a poor prognosis and limited therapeutic options.

Publications & conference data

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

1. Gut Microbiota Influence in Hematological Malignancies: From Genesis to Cure.
   Uribe-Herranz M, Klein-González N, Rodríguez-Lobato LG, Juan M, et al · · 2021 · cited 54× · PMID 33498529 · DOI 10.3390/ijms22031026
2. Roles of the intestinal microbiota and microbial metabolites in acute GVHD.
   Lin D, Hu B, Li P, Zhao Y, et al · · 2021 · cited 48× · PMID 34706782 · DOI 10.1186/s40164-021-00240-3
3. Gut microbiota, microbiota-derived metabolites, and graft-versus-host disease.
   Yue X, Zhou H, Wang S, Chen X, et al · · 2024 · cited 26× · PMID 38239049 · DOI 10.1002/cam4.6799
4. The Role of Fecal Microbiota Transplantation in the Treatment of Acute Graft-versus-Host Disease.
   Biliński J, Jasiński M, Basak GW. · · 2022 · cited 24× · PMID 35453587 · DOI 10.3390/biomedicines10040837
5. Interplay Between the Intestinal Microbiota and Acute Graft-Versus-Host Disease: Experimental Evidence and Clinical Significance.
   Hong T, Wang R, Wang X, Yang S, et al · · 2021 · cited 23× · PMID 33815399 · DOI 10.3389/fimmu.2021.644982
6. Treating From the Inside Out: Relevance of Fecal Microbiota Transplantation to Counteract Gut Damage in GVHD and HIV Infection.
   Ouyang J, Isnard S, Lin J, Fombuena B, et al · · 2020 · cited 20× · PMID 32850913 · DOI 10.3389/fmed.2020.00421
7. Applications of gut microbiota in patients with hematopoietic stem-cell transplantation.
   Yu J, Sun H, Cao W, Han L, et al · · 2020 · cited 19× · PMID 33292670 · DOI 10.1186/s40164-020-00194-y
8. The role of the intestinal microbiota in allogeneic HCT: clinical associations and preclinical mechanisms.
   Nguyen CL, Docampo MD, van den Brink MR, Markey KA. · · 2021 · cited 14× · PMID 33388483 · DOI 10.1016/j.gde.2020.11.007