Impact of Intestinal Virome on Pediatric Inflammatory Bowel Disease

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

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Key information

Conditions

Inflammatory Bowel Diseases Digestive System Diseases Gastroenteritis Gastrointestinal Diseases Intestinal Diseases

Age range

6 year–17 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Service de gastroentérologie nutrition, hépatologie pédiatrique - Hôpital Femme Mère Enfant groupement hospitalier Est - HCL

Bron, 69677, France

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Collection of stool and blood samples

Other

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.

Primary outcomes

Evaluation over time of change of the gut virome

Time frame: at the inclusion, 6 months and one year

Abundance 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
Evaluation over time of change of the gut virome

Time frame: at the inclusion, 6 months and one year

Measure of relative abundance: abundance of a given family or species relative to other species or families in the sample.

eukaryote versus prokaryote virus

Viral isolation, extraction, and amplification of viral nucleic acids from patient's stools.

Next generation sequencing Statistical analysis
Evaluation over time of change of the gut virome

Time frame: at the inclusion, 6 months and one year

Measure of alpha diversity by the Shannon index which takes into account the number of species present, but also the distribution of these species.

Viral isolation, extraction, and amplification of viral nucleic acids from patient's stools.

Next generation sequencing Statistical analysis

Sponsors and collaborators

Lead sponsor

Hospices Civils de Lyon

Other

Registry information

Acronym: IVOIRE

Important dates

Study start: 2019
Primary completion: 2022
Study completion: 2022
First posted: May 30, 2019
Registry last updated: Nov 29, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed