Impact of Intestinal Virome on Pediatric Inflammatory Bowel Disease

NCT03967236 | Completed

• 1 other identifier: 69HCL18_0794
• Study Type: observational
• Target: 20
• Locations: 1 country
• Sites: 1

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

Conditions

Inflammatory Bowel Diseases

Outcome Measures

Primary Outcomes (3)

• 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

• 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

• 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

Interventions

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.

Eligibility Criteria

• Age: 6 Years - 17 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)
• 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

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Hospices Civils de Lyon: lead

Study Sites (1)

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

Bron, 69677, France

Location

Biospecimen

Retention: SAMPLES WITH DNA

Stool and blood samples from paediatric inflammatory bowel disease patients.

MeSH Terms

Conditions

Inflammatory Bowel Diseases

Interventions

Blood Specimen Collection

Condition Hierarchy (Ancestors)

Gastroenteritis; Gastrointestinal Diseases; Digestive System Diseases; Intestinal Diseases

Intervention Hierarchy (Ancestors)

Specimen Handling; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Punctures; Surgical Procedures, Operative; Investigative Techniques

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 23, 2019
• First Posted: May 30, 2019
• Study Start: July 10, 2019
• Primary Completion: February 28, 2022
• Study Completion: February 28, 2022
• Last Updated: November 29, 2022

Record last verified: 2022-11

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)