IVOIRE: Impact of Intestinal Virome on Pediatric Inflammatory Bowel Disease

Sponsor
Hospices Civils de Lyon (Other)
Overall Status
Unknown status
CT.gov ID
NCT03967236
Collaborator
(none)
20
1
23.7
0.8

Study Details

Study Description

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

Condition or Disease Intervention/Treatment Phase
  • Other: Collection of stool and blood samples

Study Design

Study Type:
Observational
Anticipated Enrollment :
20 participants
Observational Model:
Cohort
Time Perspective:
Prospective
Official Title:
Impact of Intestinal Virome on Pediatric Inflammatory Bowel Disease
Actual Study Start Date :
Jul 10, 2019
Anticipated Primary Completion Date :
Jul 1, 2021
Anticipated Study Completion Date :
Jul 1, 2021

Outcome Measures

Primary Outcome Measures

  1. Evaluation over time of change of the gut virome [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

  2. Evaluation over time of change of the gut virome [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

  3. 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

Eligibility Criteria

Criteria

Ages Eligible for Study:
6 Years to 17 Years
Sexes Eligible for Study:
All
Accepts 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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Service de gastroentérologie nutrition, hépatologie pédiatrique - Hôpital Femme Mère Enfant groupement hospitalier Est - HCL Bron France 69677

Sponsors and Collaborators

  • Hospices Civils de Lyon

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Hospices Civils de Lyon
ClinicalTrials.gov Identifier:
NCT03967236
Other Study ID Numbers:
  • 69HCL18_0794
First Posted:
May 30, 2019
Last Update Posted:
Mar 30, 2020
Last Verified:
Mar 1, 2020
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of Mar 30, 2020