Defilipp, Zachariah and V. Damania, Ashish and Kim, Haesook T. and Chang, Chia-Chi and El-Jawahri, Areej and Mcafee, Steven L. and Bottoms, A. J. S. and Toncheva, Vesselina and Smith, Melissa M. and Dolaher, Maria and Perry, Lindsey and White, Meghan and Diana, Brittany and Connolly, Sheila and Dey, Bimalangshu R. and Frigault, Matthew J. and Newcomb, Richard A. and V. O'Donnell, Paul and Spitzer, Thomas R. and Mansour, Michael K. and Weber, Daniela and Ajami, Nadim J. and Hohmann, Elizabeth and Jenq, Robert R. and Chen, Yi-Bin (2024) Third-party fecal microbiota transplantation for high-risk treatment-naïve acute GVHD of the lower GI tract. BLOOD ADVANCES, 8 (9). pp. 2074-2084. ISSN 2473-9529, 2473-9537
Full text not available from this repository. (Request a copy)Abstract
Disruption of the intestinal microbiome is observed with acute graft-versus-host disease (GVHD) of the lower gastrointestinal (LGI) tract, and fecal microbiota transplantation (FMT) has successfully cured steroid-refractory cases. In this open-label, single -arm, pilot study, third-party, single -donor FMT was administered in combination with systemic corticosteroids to participants with high -risk acute LGI GVHD, with a focus on treatmentna & iuml;ve cases. Participants were scheduled to receive 1 induction dose (15 capsules per day for 2 consecutive days), followed by 3 weekly maintenance doses, consisting of 15 capsules per dose. The primary end point of the study was feasibility, which would be achieved if >= 80% of participants able to swallow >= 40 of the 75 scheduled capsules. Ten participants (9 treatmentna & iuml;ve; 1 steroid-refractory) were enrolled and treated. The study met the primary end point, with 9 of 10 participants completing all eligible doses. Organ-speci fic LGI complete response rate at day 28 was 70%. Initial clinical response was observed within 1 week for all responders, and clinical responses were durable without recurrent LGI GVHD in complete responders. Exploratory analyses suggest that alpha diversity increased after FMT. Although recipient microbiome composition never achieved a high degree of donor similarity, expansion of donor-derived species and increases in tryptophan metabolites and short-chain fatty acids were observed within the first 7 days after FMT. Investigation into the use of microbiome-targeted interventions earlier in the treatment paradigm for acute LGI GVHD is warranted. This trial was registered at www.ClinicalTrials.gov as #NCT04139577.
| Item Type: | Article |
|---|---|
| Uncontrolled Keywords: | VERSUS-HOST-DISEASE; SURVIVAL; SCORE |
| Subjects: | 600 Technology > 610 Medical sciences Medicine |
| Divisions: | Medicine > Lehrstuhl für Innere Medizin III (Hämatologie und Internistische Onkologie) |
| Depositing User: | Dr. Gernot Deinzer |
| Date Deposited: | 22 Jan 2026 07:35 |
| Last Modified: | 22 Jan 2026 07:35 |
| URI: | https://pred.uni-regensburg.de/id/eprint/65176 |
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