Evidence map›Paper›PMID 42322204›Full record

Trial reportInflammatory bowel diseases2026

Modified Crohn's Disease Exclusion Diet and exclusive enteral nutrition (EEN) resolve oral dysbiosis in pediatric Crohn's disease: a prospective cohort study.

Gary P Moran, Adam McQuillan, Gwo-Tzer Ho, Robert J Whelan, Víctor Manuel Navas-López, Sally Lawrence, Helena Rolandsdotter, Ola Olen, Javier Martín-de-Carpi, Rotem Sigall Boneh and 2 more

Registry-linked trialAbstract readRandomized Controlled Trial
In one paragraph

Trial report in Inflammatory bowel diseases, 2026. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT02843100 (Modified Exclusive Enteral Nutrition With the Crohn's Disease Exclusion Diet for Induction and Maintenance of Remission and Re-biosis), which is not on this map. Not yet cited in PubMed.

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0cells of the map it votes in
0citing papers in PubMed
–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.

NCT02843100 nacompletednot on this map

Modified Exclusive Enteral Nutrition With the Crohn's Disease Exclusion Diet for Induction and Maintenance of Remission and Re-biosis

TypeinterventionalSponsorProf. Arie LevineRan2018 to 2022Enrolled63ConditionsCrohn's DiseaseArmsModified Exclusive Enteral Nutrition, Crohn's Disease Exclusion Diet, Partial Enteral Nutrition, Standard Exclusive Enteral Nutrition
3 · Its place in the literature

Who cites it

0 citing papers in PubMed.

No citing paper in PubMed yet.

4 · The record

Corrections and comments

5 · Who and what money

Authors and funding

12 authors.

Gary P MoranSchool of Dental Science, Trinity College Dublin and Dublin Dental University Hospital, Dublin D02 F859, Ireland.ORCID 0000-0003-0469-1788
Adam McQuillanSchool of Dental Science, Trinity College Dublin and Dublin Dental University Hospital, Dublin D02 F859, Ireland.
Gwo-Tzer HoSchool of Infection and Immunity, University of Glasgow, Glasgow G12 8TA, United Kingdom.ORCID 0000-0002-6014-372X
Robert J WhelanSchool of Infection and Immunity, University of Glasgow, Glasgow G12 8TA, United Kingdom.
Víctor Manuel Navas-LópezPediatric Gastroenterology and Nutrition Unit, Hospital Regional Universitario de Málaga, Biomedical Research Institute of Malaga (IBIMA), Málaga 29590, Spain.
Sally LawrenceDepartment of Pediatrics, Division of Gastroenterology, Hepatology and Nutrition, British Columbia Children's Hospital, University of British Columbia, Vancouver, BC V6H 3V4, Canada.
Helena RolandsdotterDepartment of Clinical Science and Education, Södersjukhuset, Karolinska Institutet, 171 77 Stockholm, Sweden.
Ola OlenDepartment of Gastroenterology, Sachs' Children and Youth Hospital, Södersjukhuset, 118 83 Stockholm, Sweden.
Javier Martín-de-CarpiDepartment of Pediatric Gastroenterology, Hepatology and Nutrition, Sant Joan de Déu Barcelona, 08950 Barcelona, Spain.
Rotem Sigall BonehPediatric Gastroenterology and Nutrition Unit, The E. Wolfson Medical Center, Holon, 58100, Israel.
Eytan WineDepartment of Pediatrics, University of Alberta, Edmonton, AB T6G 1C9, Canada.
Séamus HusseyDepartment of Paediatrics, University of Medicine and Health Sciences, RCSI Dublin and University College Dublin D02 YN77, Ireland.

Funding

Children's Health Foundation c/18/2Children's Health Foundation, Dublin, Ireland NCRC c/18/2
6 · The paper itself

Abstract

BACKGROUND AND

aimsChanges to the oral microbiome have been reported in patients with Crohn's disease (CD). The aim of this study was to determine the characteristics and dynamics of the oral microbiome in children randomized to 1 of 2 nutritional treatments for CD.

methodsParticipants (n = 54) in this randomized controlled trial (NCT02843100) received the Crohn's Disease Exclusion Diet (CDED) with either partial enteral nutrition (PEN; n = 28) or exclusive enteral nutrition (EEN; n = 26). The oral microbiome was assessed via swabs from the dorsum of the tongue and the buccal gingiva by 16S rRNA sequencing at 0, 2, 8, 14, 24, and 52 weeks.

resultsThere were no significant differences in primary or clinical outcomes between the 2 groups. Due to the COVID-19 pandemic, sampling by 24 weeks was limited to 34 participants. At week 0, moderate-severe disease activity (Pediatric Crohn's Disease Activity Index [PCDAI] > 30) was associated with decreased Porphyromonas, Haemophilus, Alloprevotella, Neisseria, and Bergeyella species and increased Actinomyces. As patients entered remission (PCDAI < 10), we observed a restoration in the abundance of these taxa. A modified oral dysbiosis index (MODI) was generated, capable of distinguishing mild from moderate-severe disease activity based on microbiome profiles. Dysbiosis decreased as treatment continued and patients entered remission. Patients on CDED exhibited more significant dysbiosis index changes at weeks 8-24, compared with the EEN group. Application of the index across published oral microbiome data sets validated its ability to discriminate health from CD.

conclusionOral microbiome changes in pediatric CD reflect disease activity and parallel therapeutic response to CDED and EEN over time. Additional validation of the proposed dysbiosis index should be undertaken in adequately powered future studies.

Indexed as

Crohn DiseaseDysbiosisEnteral NutritionMouthAdolescentChildCOVID-19FemaleHumansMaleMicrobiotaProspective StudiesCrohn's diseaseCrohn's Disease Exclusion Dietexclusive enteral nutritionoral microbiomepediatric

Identifiers

PMID42322204
PMCPMC13414547

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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.