Fecal microbiota transplantation restores gut microbiota diversity in children with active Crohn's disease: a prospective trialOriginal paper
Karen Pendergrass is a microbiome researcher specializing in microbiome-targeted interventions (MBTIs). She systematically analyzes scientific literature to identify microbial patterns, develop hypotheses, and validate interventions. As the founder of the Microbiome Signatures Database, she bridges microbiome research with clinical practice. In 2012, based on her own investigative research, she became the first documented case of FMT for Celiac Disease, four years before the first published case study.
Read MoreWhat was studied?
This trial tested whether oral fecal microbiota transplant capsules could safely treat active Crohn's disease in children. It was an open-label, single-center prospective study run in Wuhan, China, from 2022 to 2023. The capsule group took oral freeze-dried donor stool capsules combined with partial enteral nutrition at 80 percent of calories. The control group received partial enteral nutrition plus immunosuppressants. Capsules were given in periodic courses at weeks 0 and 5. Researchers tracked clinical scores, inflammatory markers, and stool 16S rRNA sequencing at weeks 0, 5, and 10.
Who was studied?
The study enrolled 33 children with active Crohn's disease, mean age 11.6 years. Seventeen received oral transplant capsules and 16 served as controls. Active disease was defined by a pediatric activity index above 10, endoscopic score above 3, and elevated fecal calprotectin. Cases ranged from mild to severe activity. Stool donors were healthy children of similar age. Fifty-eight fecal samples from the capsule group, including 16 from healthy donors, were sequenced across the timepoints.
What were the most important findings?
By week 10, clinical remission reached 76.5 percent in the capsule group versus 75 percent in controls, with no significant difference. Fecal calprotectin, C-reactive protein, sedimentation rate, and endoscopic and activity scores all dropped significantly in the capsule group. Before treatment, six beneficial genera were depleted: Agathobacter, Akkermansia, Roseburia, Blautia, Subdoligranulum, and Faecalibacterium. After capsules, these genera colonized significantly and microbial diversity approached healthy-donor levels. These genera correlated positively with anti-inflammatory IL-10 and negatively with IL-6. Combined, they distinguished children with Crohn's from healthy children with an area under the curve of 0.96 to 0.98. The main adverse event was mild-to-moderate constipation.
What are the greatest implications of this study?
Oral transplant capsules plus enteral nutrition may offer children with Crohn's disease a less invasive alternative to immunosuppressants, matching their remission rates in this small trial. The six core functional genera could serve as candidate biomarkers for diagnosis and treatment response. The findings are early and limited. The sample was small, non-randomized, and included refractory patients only in the capsule group, so bias is possible and causation cannot be claimed.