Research Summary

Oral FMT Capsules Plus Enteral Nutrition Show Promise for Pediatric Crohn Disease

Kate Young

Key Highlights:

  • Oral FMT capsules combined with partial enteral nutrition (PEN 80%) were as effective as immunosuppressants plus PEN in inducing clinical and endoscopic remission in pediatric Crohn disease (CD).
  • The treatment significantly improved gut microbiota diversity and abundance, with successful implantation of six core beneficial bacterial genera.
  • The six functional bacterial genera identified may serve as potential biomarkers for diagnosis and therapeutic monitoring of pediatric CD.
  • Inflammatory markers (CRP, ESR, IL-6) decreased and anti-inflammatory IL-10 increased significantly post-FMT treatment.

In a prospective trial of pediatric patients with active Crohn disease, oral fecal microbiota transplantation (FMT) capsules combined with partial enteral nutrition (PEN 80%) demonstrated clinical efficacy comparable to standard treatment with immunosuppressants and PEN. By week 10, 76.5% of patients in the capsule group achieved clinical remission, with similar endoscopic remission rates and improvements in inflammatory markers, growth metrics, and microbial diversity. The study by Zou and colleagues also identified six core functional bacterial genera associated with treatment response and reduced inflammation.

This study addresses a critical therapeutic gap in pediatric Crohn disease (CD), where traditional immunosuppressive treatments pose risks of adverse events, tolerance, and recurrence. According to the study authors, microbiota-directed therapies such as FMT offer a promising, mechanistically rational approach. Oral FMT capsules particularly present a scalable delivery route for children, the authors found.

Researchers conducted an open-label, parallel-group trial at a single center, enrolling 33 pediatric patients aged 6-15 years with active CD. Seventeen patients received oral FMT capsules combined with PEN 80%, while 16 control patients received PEN 80% and immunosuppressive agents. The FMT capsules were administered in two courses, at weeks 0 and 5, totaling 120 capsules per patient. Clinical assessments included Pediatric Crohn's Disease Activity Index (PCDAI), Simple Endoscopic Score for Crohn's Disease, fecal calprotectin, C-reactive protein (CRP), erythrocyte sedimentation rate (ESR), and vitamin D levels. Microbiota composition was evaluated through 16S rRNA sequencing of stool samples collected at baseline, week 5, and week 10.

Both treatment groups showed comparable improvements by week 10 in clinical and endoscopic remission, with significant reductions in fecal calprotectin, CRP, ESR, and PCDAI scores in the capsule group. The mean height, weight, and BMI also improved significantly. Cytokine analysis revealed a notable increase in IL-10 and decrease in IL-6 levels in the FMT group. Microbiota analyses demonstrated enhanced alpha and beta diversity post-treatment, with microbiome composition trending toward that of healthy donors. Six beneficial genera—Agathobacter, Akkermansia, Roseburia, Blautia, Subdoligranulum, and Faecalibacterium—were markedly increased after treatment and inversely correlated with pro-inflammatory cytokines.

No serious adverse events occurred during the study. Mild-to-moderate constipation was the most common side effect, affecting 58.8% of FMT-treated patients, and resolved in most cases with dietary modifications or short-term laxative use.

Limitations of this study include the small sample size, lack of randomization, and an imbalance in treatment history between groups, as six refractory patients were included in the capsule group but not the control group.

“We observed bacterial implantation after oral administration of FMT capsules matched the clinical symptoms,” the study authors concluded. “Moreover, we identified six core functional genera that may be candidate biomarkers for distinguishing children with CD from healthy children.”

Reference:
Zou B, Liu S, Dong C, et al. Fecal microbiota transplantation restores gut microbiota diversity in children with active Crohn's disease: a prospective trial. J Transl Med. 2025;23(1):288. Published 2025 Mar 6. doi:10.1186/s12967-024-05832-1