Impact of Intestinal Virome on Pediatric Inflammatory Bowel Disease

Completed

• Conditions: Inflammatory Bowel Diseases

• Registration Number: NCT03967236
• Lead Sponsor: Hospices Civils de 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

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2019-05-23
• Study First Submitted QC: 2019-05-28
• Study First Posted: 2019-05-30
• Study Start: 2019-07-10
• Primary Completion: 2022-02-28
• Study Completion: 2022-02-28
• Status Verified: 2022-11
• Last Update Submitted: 2022-11-28
• Last Update Posted: 2022-11-29

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 20

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

Read More

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

Read More

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Evaluation over time of change of the gut virome	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

Trial Locations

Locations (1)

Service de gastroentérologie nutrition, hépatologie pédiatrique - Hôpital Femme Mère Enfant groupement hospitalier Est - HCL; 🇫🇷 Bron, France