NCT03862079

Fecal Transplant +/- Gut Decontamination in Preventing Acute Graft Versus Host Disease in Patients Given Broad-Spectrum Antibiotics

Withdrawn Phase 2 Last updated 4 March 2020

What this trial tests

Phase 2 trial testing Best Practice in Graft-versus-host Disease Prevention. Withdrawn.

Timeline

1 June 2020

Primary endpoint
31 December 2021

31 December 2021

Quick facts

Lead sponsor	M.D. Anderson Cancer Center
Phase	Phase 2
Status	Withdrawn
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	none
Primary purpose	prevention
Start date	1 June 2020
Primary completion	31 December 2021
Estimated completion	31 December 2021
Sites	1 location across United States

Drugs / interventions tested

• Best Practice
• Fecal Microbiota Transplantation — full drug profile →
• Nystatin (nystatin) — full drug profile →
• Piperacillin-Tazobactam — full drug profile →

Conditions studied

• Graft-versus-host Disease Prevention — all drugs for Graft-versus-host Disease Prevention →

Sponsor

M.D. Anderson Cancer Center — full company profile →

Who can join

Adults 16 to 75, any sex, with Graft-versus-host Disease Prevention. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

This phase II trial studies how well a fecal microbiota transplant with or without total gut decontamination works in preventing graft versus host disease in patients exposed to broad-spectrum antibiotics. Fecal microbiota transplantation is the administration by enema of fecal matter (stool) that includes helpful bacteria from a normal, healthy donor. Total gut decontamination uses antibiotics to remove/reduce the amount of bacteria in the digestive system. It is not yet known if a fecal microbiota transplant with or without total gut decontamination works better in preventing graft versus host disease compared to standard immunosuppressive therapies (therapies that lower the normal function of the immune system).

Publications & conference data

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

1. 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
2. Prevention and Treatment of Acute Graft-versus-Host Disease in Children, Adolescents, and Young Adults.
   Gatza E, Reddy P, Choi SW. · · 2020 · cited 41× · PMID 31931115 · DOI 10.1016/j.bbmt.2020.01.004
3. Microbiota modification in hematology: still at the bench or ready for the bedside?
   Severyn CJ, Brewster R, Andermann TM. · · 2019 · cited 22× · PMID 31714965 · DOI 10.1182/bloodadvances.2019000365
4. 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
5. Microbiome Anomalies in Allogeneic Hematopoietic Cell Transplantation.
   Schwabkey ZI, Jenq RR. · · 2020 · cited 17× · PMID 31986084 · DOI 10.1146/annurev-med-052918-122440
6. Microbiota modification in hematology: still at the bench or ready for the bedside?
   Severyn CJ, Brewster R, Andermann TM. · · 2019 · cited 5× · PMID 31808861 · DOI 10.1182/hematology.2019000365