Evidence map›Paper›PMID 40050917›Full record

Trial reportJournal of translational medicine2025

Fecal microbiota transplantation restores gut microbiota diversity in children with active Crohn's disease: a prospective trial.

Biao Zou, Shengxuan Liu, Chen Dong, Hexiao Shen, Yongling Lv, Jiayi He, Xuesong Li, Mengling Ruan, Zhihua Huang, Sainan Shu

2 registry-linked trialsAbstract readClinical Trial
In one paragraph

Trial report in Journal of translational medicine, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to 2 registered trials, which are not on this map. Cited by 14 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
14citing papers in PubMed, 1 pooled it
–field-weighted citation impact
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

NCT05321745 narecruitingnot on this map

Repeated and Periodic Fecal Microbiota Transplantation in Children With Active and Refractory Crohn's Disease

TypeinterventionalSponsorBiao ZouRan2022 to 2027Enrolled40ConditionsCrohn DiseaseArmsStandardized FMT
NCT05321758 narecruitingnot on this map

Repeated and Multiple Fecal Microbiota Transplantations Plus Partial Enteral Nutrition as the First-line Treatment in Active Pediatric Crohn's Disease

TypeinterventionalSponsorTongji HospitalRan2020 to 2027Enrolled50ConditionsCrohn DiseaseArmsFecal Microbiota Transplantation, Immunosuppressive Agents
3 · Its place in the literature

Who cites it

14 citing papers in PubMed, 1 synthesis or guideline pooled it.

  1. Pooled it
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  10. CD74Journal of translational medicine · 2025
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4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

10 authors.

Biao Zou *Pediatric Department, Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology, No. 1095, Jiefang Road, Wuhan, 430030, Hubei, China.
Shengxuan Liu *Pediatric Department, Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology, No. 1095, Jiefang Road, Wuhan, 430030, Hubei, China.
Chen DongPediatric Department, Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology, No. 1095, Jiefang Road, Wuhan, 430030, Hubei, China.
Hexiao ShenSchool of Life Science, Hubei University, Wuhan, 430030, Hubei, China.
Yongling LvSchool of Life Science, Hubei University, Wuhan, 430030, Hubei, China.
Jiayi HePediatric Department, Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology, No. 1095, Jiefang Road, Wuhan, 430030, Hubei, China.
Xuesong LiPediatric Department, Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology, No. 1095, Jiefang Road, Wuhan, 430030, Hubei, China.
Mengling RuanPediatric Department, Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology, No. 1095, Jiefang Road, Wuhan, 430030, Hubei, China.
Zhihua HuangPediatric Department, Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology, No. 1095, Jiefang Road, Wuhan, 430030, Hubei, China.
Sainan ShuPediatric Department, Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology, No. 1095, Jiefang Road, Wuhan, 430030, Hubei, China. snshu@tjh.tjmu.edu.cn.ORCID 0000-0001-6071-9656

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundClinical 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.

methodsIn 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.

resultsAt 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).

conclusionsOral 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 registrationClinicalTrials.gov, retrospectively registered, ID# NCT05321758, NCT05321745, date of registration: 2022-04-04.

Indexed as

Crohn DiseaseFecal Microbiota TransplantationGastrointestinal MicrobiomeAdolescentBiomarkersChildFecesFemaleHumansMaleProspective StudiesTreatment OutcomeBiomarkersChildrenCore functional generaCrohn’s diseaseEfficacy and safetyOral fecal microbiota capsules

Identifiers

PMID40050917
PMCPMC11887145

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Registered trials

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.