NCT02902445

Brief Summary

The GASTROVIM research explores the links between individual genetic susceptibility, genetic variability of rotavirus strains and effectiveness of immunization with the rotavirus vaccination: a clinical investigation to assess glycan attachment specificity, toward rotavirus vaccine improvement.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
611

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Feb 2017

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 12, 2016

Completed
3 days until next milestone

First Posted

Study publicly available on registry

September 15, 2016

Completed
6 months until next milestone

Study Start

First participant enrolled

February 28, 2017

Completed
3.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 15, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 15, 2020

Completed
Last Updated

April 11, 2022

Status Verified

April 1, 2021

Enrollment Period

3.6 years

First QC Date

September 12, 2016

Last Update Submit

April 8, 2022

Conditions

GastroenteritisAcute Gastroenteritis

Keywords

VaccinePolymorphism

Outcome Measures

Primary Outcomes (1)

  • Absence / Presence of non-secretory polymorphisms FUT2- and Lewis Negative FUT3-

    6 months after inclusion

Secondary Outcomes (5)

  • Population frequency of new protective genotypes to rotavirus infection

    Six months after inclusion

  • Absence / presence of genetic polymorphisms --other (Including FUT2- and FUT3-)

    Six months after inclusion

  • Absence / presence of different viral strains Rotavirus (RVA) involved in the acute gastroenteritis episodes in French Guiana

    Six months after inclusion

  • Absence / presence of various HBGA polymorphisms involved in acute gastroenteritis episodes in French Guiana

    Six months after inclusion

  • population frequency of different etiologies of acute gastroenteritis viral, bacterial and / or parasitic (Cayenne)

    Six months after inclusion

Study Arms (2)

Case group

250 children from Nantes University Hospital and 150 children from Guyana Hospital admitted in paediatric emergency unit for diagnosed rotavirus acute gastroenteritis: rotavirus rapid screen test and oral swab for polymorphism exploration

Biological: rotavirus rapid screen testGenetic: polymorphism exploration

Control group

250 children from Nantes University Hospital and 150 children from Guyana Hospital admitted in paediatric emergency unit without signs of infection and / or digestive clinical picture evocative of gastroenteritis. Paired with a case upon ethnicity or origin if impossible to match the ethnicity of the case. oral swab for polymorphism exploration

Genetic: polymorphism exploration

Interventions

rotavirus rapid screen testBIOLOGICAL

According to routine care

Case group
polymorphism explorationGENETIC

from an oral swab collected after parents consent

Case groupControl group

Eligibility Criteria

AgeUp to 16 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)
Sampling MethodNon-Probability Sample
Study Population

400 children admitted to the pediatric emergency for acute gastroenteritis (cases) and 400 children admitted to the pediatric emergency without evocative picture of infection or gastroentieritis

You may qualify if:

  • to 16.
  • giving consent to participate if applicable (\>6yo)
  • Parents informed and written consent obtained
  • admitted in paediatric emergency for wether an acute gastroenteritis (case group) or anything else than an infection or gastroenteritis (control group)

You may not qualify if:

  • case group: rotavirus rapid screen test negative; viral gastroenteritis other than rotavirus; bacterial gastroenteritis
  • control group: Family and / or patient unable to full informed consent to research; Infectious Pathology context in general.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Nantes University Hospital

Nantes, Loire-Atlantique, 44093, France

Location

Biospecimen

Retention: SAMPLES WITH DNA

Oral swab

MeSH Terms

Conditions

Gastroenteritis

Condition Hierarchy (Ancestors)

Gastrointestinal DiseasesDigestive System Diseases

Study Officials

  • Christèle GRAS-LEGUEN, MD PhD

    Nantes University Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 12, 2016

First Posted

September 15, 2016

Study Start

February 28, 2017

Primary Completion

October 15, 2020

Study Completion

October 15, 2020

Last Updated

April 11, 2022

Record last verified: 2021-04

Locations

FR(1)