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Impact of Intestinal Virome on Pediatric Inflammatory Bowel Disease

Impact of Intestinal Virome on Pediatric Inflammatory Bowel Disease

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT03967236
Acronym
IVOIRE
Enrollment
20
Registered
2019-05-30
Start date
2019-07-10
Completion date
2022-02-28
Last updated
2022-11-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Inflammatory Bowel Diseases

Brief summary

Over the last few years, dysbiosis has emerged as a possible trigger of gut inflammation in inflammatory bowel disease (IBD) and a promising therapeutic target. The complex diversity of microbiota was initially highlighted by the powerful new tools in genetics, including next-generation sequencing (NGS). NGS permitted to decipher the composition of bacterial intestinal communities, but also that of the gut virome. Since then, the evidence of a dynamic instability of the enteric virome in IBD has grown considerably. IBD patients present an expansion of bacteriophages (Caudovirales) associated with decreased bacterial diversity. Moreover, gut virome richness seems to differ between Crohn's disease (CD) and ulcerative colitis (UC) patients. These insights open the gate of new diagnostic, predictive, and therapeutic approaches. However, little is known about pediatric IBD gut virome in terms of variability and evolution under the influence of different treatments (exclusive enteral nutrition, immunosuppressive therapy and biologics). The aim of this study is to evaluate the gut family viral diversity and relative abundance of eukaryotes and prokaryotes in paediatric IBD patients

Interventions

OTHERCollection of stool and blood samples

For each visit, stool and blood samples will be collected during a pediatric gastroenterology day hospital stay. This collection of stool and blood specific IVOIRE study is carried out in the context of examination already planned for the usual care of the patient.

Sponsors

Hospices Civils de Lyon
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
6 Years to 17 Years
Healthy volunteers
No

Inclusion criteria

* Age: 6-17 years * Follow-up in pediatric gastroenterology for inflammatory bowel disease : * Crohn's disease * Hemorrhagic rectocolitis * Introduction of anti-TNFa treatment in the Pediatric Gastroenterology Day Hospital of the Hôpital Femme Mère Enfant service in Lyon * Collection of the non-opposition of at least one of the holders of the parental authority present and the child in the medical file

Exclusion criteria

* Refusal to participate in the study * Antibiotherapy in the 4 weeks preceding the sampling * Patient with ileostomy or colostomy. * Patient who has undergone extensive bowel resection. * History of intestinal surgery (except appendectomy) * Patient subject to a legal protection measure

Design outcomes

Primary

MeasureTime frameDescription
Evaluation over time of change of the gut viromeat the inclusion, 6 months and one yearAbundance measure: number of sequences generated for a given family or species. Viral isolation, extraction, and amplification of viral nucleic acids from patient's stools. Next generation sequencing Statistical analysis

Countries

France

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026