Clinical trial NCT03967236: Impact of Intestinal Virome on Pediatric Inflammatory Bowel Disease
Official title: Impact of Intestinal Virome on Pediatric Inflammatory Bowel Disease
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Inflammatory Bowel Diseases
Lead sponsor: Hospices Civils de Lyon
Sponsor class: OTHER
First posted: 2019-05-30
Enrollment: 20
Sex: ALL
Minimum age (years): 6
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Children with nflammatory bowel disease newly treated with anti-TNF therapy in the "Hôpital Femme Mère Enfant" center in Lyon

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


Eligibility criteria: 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

Primary outcomes:
measure: Evaluation over time of change of the gut virome
timeFrame: at the inclusion, 6 months and one year
measure: Evaluation over time of change of the gut virome
timeFrame: at the inclusion, 6 months and one year
measure: Evaluation over time of change of the gut virome
timeFrame: at the inclusion, 6 months and one year
Secondary outcomes:
Other outcomes:
Locations:
city: Bron
country: France
facility: Service de gastroentérologie nutrition, hépatologie pédiatrique - Hôpital Femme Mère Enfant groupement hospitalier Est - HCL
Study officials:
References: