Impact of Intestinal Virome on Pediatric Inflammatory Bowel Disease

Inflammatory Bowel Diseases Clinical Trial

— IVOIRE  

Official title:

Impact of Intestinal Virome on Pediatric Inflammatory Bowel Disease

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03967236
• Other study ID #: 69HCL18_0794
• Status: Completed
• Start date: July 10, 2019
• Est. completion date: February 28, 2022

Study information

• Verified date: November 2022
• Source: Hospices Civils de Lyon
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20
• Est. completion date: February 28, 2022
• Est. primary completion date: February 28, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 6 Years to 17 Years

Eligibility

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

Related Conditions & MeSH terms

• Inflammatory Bowel Diseases
• Intestinal Diseases

Intervention

Other:
• Collection 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.

Locations

Country	Name	City	State
France	Service de gastroentérologie nutrition, hépatologie pédiatrique - Hôpital Femme Mère Enfant groupement hospitalier Est - HCL	Bron

Sponsors (1)

Lead Sponsor	Collaborator
Hospices Civils de Lyon

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Evaluation over time of change of the gut virome	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	at the inclusion, 6 months and one year
Primary	Evaluation over time of change of the gut virome	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	at the inclusion, 6 months and one year
Primary	Evaluation over time of change of the gut virome	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	at the inclusion, 6 months and one year