Fecal Microbial Transplant Effect on Clinical Outcomes and Fecal Microbiome in Active Crohnʼs Disease

TLDR

Crohn’s disease is a chronic idiopathic inflammatory intestinal disorder associated with fecal dysbiosis. The study aimed to evaluate fecal microbial transplant as a therapeutic option for pediatric Crohn’s disease by enrolling nine adolescents with mild‑to‑moderate disease. FMT was administered via nasogastric tube and patients were monitored at 2, 6, and 12 weeks with clinical indices, inflammatory markers, and safety assessments. FMT was well tolerated, engrafted in 7 of 9 patients, and produced clinical remission in 7 of 9 at 2 weeks and in 5 of 9 at 6 and 12 weeks, while non‑engrafting patients showed minimal improvement. Further prospective studies are needed to confirm the safety and efficacy of FMT in Crohn’s disease.

Abstract

Crohn's disease (CD) is a chronic idiopathic inflammatory intestinal disorder associated with fecal dysbiosis. Fecal microbial transplant (FMT) is a potential therapeutic option for individuals with CD based on the hypothesis that changing the fecal dysbiosis could promote less intestinal inflammation.Nine patients, aged 12 to 19 years, with mild-to-moderate symptoms defined by Pediatric Crohn's Disease Activity Index (PCDAI of 10-29) were enrolled into a prospective open-label study of FMT in CD (FDA IND 14942). Patients received FMT by nasogastric tube with follow-up evaluations at 2, 6, and 12 weeks. PCDAI, C-reactive protein, and fecal calprotectin were evaluated at each study visit.All reported adverse events were graded as mild except for 1 individual who reported moderate abdominal pain after FMT. All adverse events were self-limiting. Metagenomic evaluation of stool microbiome indicated evidence of FMT engraftment in 7 of 9 patients. The mean PCDAI score improved with patients having a baseline of 19.7 ± 7.2, with improvement at 2 weeks to 6.4 ± 6.6 and at 6 weeks to 8.6 ± 4.9. Based on PCDAI, 7 of 9 patients were in remission at 2 weeks and 5 of 9 patients who did not receive additional medical therapy were in remission at 6 and 12 weeks. No or modest improvement was seen in patients who did not engraft or whose microbiome was most similar to their donor.This is the first study to demonstrate that FMT for CD may be a possible therapeutic option for CD. Further prospective studies are required to fully assess the safety and efficacy of the FMT in patients with CD.