Objective To assess the efficacy and safety of fecal microbiota transplantation (FMT) in the treatment of gastrointestinal graft-versus-host disease (GI-GvHD) after allogeneic hematopoietic stem cell transplantation (allo-HSCT).

Methods 25 patients with steroid-refractory GI-GvHD were enrolled in this study from 2017-2023, 1-3 doses of 4.5-8.0 U/dose fecal microbiota were infused via nasal-jejunal tube or fecal capsules. Then, the curative effect and side effects after FMT were observed.

Results

  • 25 steroid-refractory GI-GvHD patients were composed of 12 males and 13 females, mean age of 34.8 years.21 patients received haplo-HSCT, 4 received MSD-HSCT. ATG + CsA + MMF + short-term MTX were applied to prevent GvHD disease. Among them, 7 patients accompanied with liver GvHD and 11 with skin GvHD. The average onset time of GI-GvHD was +69.3d after HSCT. All patients were evaluated as grade IV GI-GvHD, and the abdominal pain score was 4 points.

  • FMT via nasal-jejunal tube wastaken in 12 patients and the rest were fecal capsules. Among the patients, 12 underwent one session of FMT, 10 underwent two sessions, and 3 underwent three sessions. Following FMT, out of the 25 patients, 21 achieved complete remission (CR) (84.0%), with symptoms such as abdominal pain, diarrhea, and bloody stools resolved. Partial remission (PR) was observed in 1 patient (4.0%), whose diarrhea volume and frequency did not meet the criteria for CR. Progressive disease (PD) occurred in 3 patients (12.0%), presenting with persistent bloody stools, cramping abdominal pain.

  • We measured the peripheral blood Treg cell counts in 16 patients who achieved CR. Prior to FMT, these patients exhibited low peripheral blood Treg cell levels. Post-FMT, their Treg cell counts significantly increased (P< 0.01), which correlated positively with the improvement in GI-GvHD symptoms.

  • We performed 16s rRNA sequencing of the gut microbiota in 16 patients during both the onset of GI-GvHD and after achieving CRof GI-GvHD. The results demonstrated that gut microbiota diversity was significantly reduced during active GI-GvHD. Following FMT and attainment of CR, the diversity of the gut microbiota showed marked improvement (P< 0.01).

  • Inthe 25 patients, 3 experienced PD, presenting with nausea, vomiting, and persistent bloody stools. These symptoms showed no improvement despite symptomatic treatment. Additionally, 6 patients who achieved CRexhibited nausea and vomiting, which were effectively controlled with symptomatic treatment. None of the patients developed FMT-related infections.

ConclusionFecal microbiota transplantation was effective and safe for steroid-refractory GI-GvHD patients after allo-HSCT.

Key wordsAllogeneic hematopoietic stem cell transplantation; Steroid-refractory gastrointestinal graft-versus-host disease；Fecal microbiota transplantation

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2025
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