Fecal microbiota transplantation restores gut microbiota diversity in children with active Crohn’s disease: a prospective trial
Abstract Background Clinical data on oral fecal microbiota transplantation (FMT), a promising therapy for Crohn’s disease (CD), are limited. Herein, we determined the short-term safety and feasibility of FMT for pediatric patients with active CD. Methods In this open-label, parallel-group, single-ce...
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BMC
2025-03-01
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| Series: | Journal of Translational Medicine |
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| Online Access: | https://doi.org/10.1186/s12967-024-05832-1 |
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| author | Biao Zou Shengxuan Liu Chen Dong Hexiao Shen Yongling Lv Jiayi He Xuesong Li Mengling Ruan Zhihua Huang Sainan Shu |
| author_facet | Biao Zou Shengxuan Liu Chen Dong Hexiao Shen Yongling Lv Jiayi He Xuesong Li Mengling Ruan Zhihua Huang Sainan Shu |
| author_sort | Biao Zou |
| collection | DOAJ |
| description | Abstract Background Clinical data on oral fecal microbiota transplantation (FMT), a promising therapy for Crohn’s disease (CD), are limited. Herein, we determined the short-term safety and feasibility of FMT for pediatric patients with active CD. Methods In this open-label, parallel-group, single-center prospective trial, patients with active CD were treated with oral FMT capsules combined with partial enteral nutrition (PEN) (80%). The control group comprised pediatric patients with active CD treated with PEN (80%) and immunosuppressants. Thirty-three patients (11.6 ± 1.82 years)—17 in the capsule and 16 in the control groups—were analyzed. Data regarding the adverse events, clinical reactions, intestinal microbiome composition, and biomarker parameters were collected and compared post-treatment. Results At week 10, the clinical and endoscopic remission rates did not differ between the two groups. By week 10, the mean fecal calprotectin level, C-reactive protein level, erythrocyte sedimentation rate, simple endoscopic score for CD, and pediatric CD activity index decreased significantly in the capsule group (all P < 0.05). The main adverse event was mild-to-moderate constipation. Core functional genera, Agathobacter, Akkermansia, Roseburia, Blautia, Subdoligranulum, and Faecalibacterium, were lacking pre-treatment. Post-treatment, the implantation rates of these core functional genera increased significantly, which positively correlated with the anti-inflammatory factor, interleukin (IL)-10, and negatively correlated with the pro-inflammatory factor, IL-6. The combination of these six functional genera distinguished healthy children from those with CD (area under the curve = 0.96). Conclusions Oral FMT capsules combined with PEN (80%) could be an effective therapy for children with active CD. The six core functional genera identified here may be candidate biomarkers for identifying children with CD. Trial registration: ClinicalTrials.gov, retrospectively registered, ID# NCT05321758, NCT05321745, date of registration: 2022-04-04. |
| format | Article |
| id | doaj-art-6f8228eee0ea49a282180705cbd96e8c |
| institution | OA Journals |
| issn | 1479-5876 |
| language | English |
| publishDate | 2025-03-01 |
| publisher | BMC |
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| series | Journal of Translational Medicine |
| spelling | doaj-art-6f8228eee0ea49a282180705cbd96e8c2025-08-20T01:57:25ZengBMCJournal of Translational Medicine1479-58762025-03-0123111410.1186/s12967-024-05832-1Fecal microbiota transplantation restores gut microbiota diversity in children with active Crohn’s disease: a prospective trialBiao Zou0Shengxuan Liu1Chen Dong2Hexiao Shen3Yongling Lv4Jiayi He5Xuesong Li6Mengling Ruan7Zhihua Huang8Sainan Shu9Pediatric Department, Tongji Hospital, Tongji Medical College, Huazhong University of Science and TechnologyPediatric Department, Tongji Hospital, Tongji Medical College, Huazhong University of Science and TechnologyPediatric Department, Tongji Hospital, Tongji Medical College, Huazhong University of Science and TechnologySchool of Life Science, Hubei UniversitySchool of Life Science, Hubei UniversityPediatric Department, Tongji Hospital, Tongji Medical College, Huazhong University of Science and TechnologyPediatric Department, Tongji Hospital, Tongji Medical College, Huazhong University of Science and TechnologyPediatric Department, Tongji Hospital, Tongji Medical College, Huazhong University of Science and TechnologyPediatric Department, Tongji Hospital, Tongji Medical College, Huazhong University of Science and TechnologyPediatric Department, Tongji Hospital, Tongji Medical College, Huazhong University of Science and TechnologyAbstract Background Clinical data on oral fecal microbiota transplantation (FMT), a promising therapy for Crohn’s disease (CD), are limited. Herein, we determined the short-term safety and feasibility of FMT for pediatric patients with active CD. Methods In this open-label, parallel-group, single-center prospective trial, patients with active CD were treated with oral FMT capsules combined with partial enteral nutrition (PEN) (80%). The control group comprised pediatric patients with active CD treated with PEN (80%) and immunosuppressants. Thirty-three patients (11.6 ± 1.82 years)—17 in the capsule and 16 in the control groups—were analyzed. Data regarding the adverse events, clinical reactions, intestinal microbiome composition, and biomarker parameters were collected and compared post-treatment. Results At week 10, the clinical and endoscopic remission rates did not differ between the two groups. By week 10, the mean fecal calprotectin level, C-reactive protein level, erythrocyte sedimentation rate, simple endoscopic score for CD, and pediatric CD activity index decreased significantly in the capsule group (all P < 0.05). The main adverse event was mild-to-moderate constipation. Core functional genera, Agathobacter, Akkermansia, Roseburia, Blautia, Subdoligranulum, and Faecalibacterium, were lacking pre-treatment. Post-treatment, the implantation rates of these core functional genera increased significantly, which positively correlated with the anti-inflammatory factor, interleukin (IL)-10, and negatively correlated with the pro-inflammatory factor, IL-6. The combination of these six functional genera distinguished healthy children from those with CD (area under the curve = 0.96). Conclusions Oral FMT capsules combined with PEN (80%) could be an effective therapy for children with active CD. The six core functional genera identified here may be candidate biomarkers for identifying children with CD. Trial registration: ClinicalTrials.gov, retrospectively registered, ID# NCT05321758, NCT05321745, date of registration: 2022-04-04.https://doi.org/10.1186/s12967-024-05832-1Oral fecal microbiota capsulesCrohn’s diseaseEfficacy and safetyCore functional generaChildren |
| spellingShingle | Biao Zou Shengxuan Liu Chen Dong Hexiao Shen Yongling Lv Jiayi He Xuesong Li Mengling Ruan Zhihua Huang Sainan Shu Fecal microbiota transplantation restores gut microbiota diversity in children with active Crohn’s disease: a prospective trial Journal of Translational Medicine Oral fecal microbiota capsules Crohn’s disease Efficacy and safety Core functional genera Children |
| title | Fecal microbiota transplantation restores gut microbiota diversity in children with active Crohn’s disease: a prospective trial |
| title_full | Fecal microbiota transplantation restores gut microbiota diversity in children with active Crohn’s disease: a prospective trial |
| title_fullStr | Fecal microbiota transplantation restores gut microbiota diversity in children with active Crohn’s disease: a prospective trial |
| title_full_unstemmed | Fecal microbiota transplantation restores gut microbiota diversity in children with active Crohn’s disease: a prospective trial |
| title_short | Fecal microbiota transplantation restores gut microbiota diversity in children with active Crohn’s disease: a prospective trial |
| title_sort | fecal microbiota transplantation restores gut microbiota diversity in children with active crohn s disease a prospective trial |
| topic | Oral fecal microbiota capsules Crohn’s disease Efficacy and safety Core functional genera Children |
| url | https://doi.org/10.1186/s12967-024-05832-1 |
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