GastroenteritisGastrovimcNCT02902445
Glycan Attachment Specificity, Toward ROtavirus Vaccine IMprovement GASTROVIMc (Clinical Investigation)
An observational study of Gastroenteritis and Acute Gastroenteritis, run by Nantes University Hospital at 1 site in France.
Trial 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. Read more about this study
- Who is it for?
- Ages Up to 16 years
- Conditions the study is for
- Gastroenteritis, Acute Gastroenteritis
- What is being tested?
- rotavirus rapid screen test and polymorphism exploration
- Type of treatment
- Pill or oral medicine
- How many people
- 611 participants
- Where
- 1 siteFrance
- Study dates
- 28 Feb 2017to 15 Oct 2020
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Up to 16 years
- All sexes
- No healthy volunteers
- Child
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
Who may be able to join
- 0 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)
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Glycan Attachment Specificity, Toward ROtavirus Vaccine IMprovement GASTROVIMc (Clinical Investigation) Evaluation of Individual Genetic Susceptibility in Severe Gastro-enteritis Rotavirus: Role of HBGA Polymorphisms & Biotechnology Improvement of RVA Vaccines
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.
Read the detailed description
The work will be carried out in France and in a tropical area of population with diverse geographical origins: the Guyana populated with Native Americans, people of European descent, people of Asian (Hmong) and a large source population African.
The first aim of the project will be to characterize the specificity of the VP8 * HBGA of RotaTeq and Rotarix vaccines in order to ensure their binding characteristics glycans are similar to those of recent P8 clinical strains circulating in France and were maintained in the culture passages.
The second objective will be to validate the impact of recently described polymorphisms HBGAs on susceptibility to infection by RVA through GASTROVIMc prospective clinical research.
The third objective will be to determine the relative role of recognition and HBGAs ganglioside in the initial attachment and viral entry.
The expression of HBGAs and ganglioside by permissive cell lines in culture human stem RVA be manipulated to define the role of glycans in attachment and infection.
- Conditions
- Gastroenteritis, Acute Gastroenteritis
- Being tested
- rotavirus rapid screen test, polymorphism exploration
- Keywords
- Vaccine, Polymorphism
- Medical subject headings
- Gastroenteritis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
rotavirus rapid screen testBiological
According to routine care
polymorphism explorationGenetic
from an oral swab collected after parents consent
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: Biological: rotavirus rapid screen test; Genetic: 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 Receives: Genetic: polymorphism exploration |
What is being measured
The primary outcome is the main question the study is designed to answer.
Absence / Presence of non-secretory polymorphisms FUT2- and Lewis Negative FUT3-
Measured: 6 months after inclusion
Secondary outcomes (5)
Population frequency of new protective genotypes to rotavirus infection
Measured: Six months after inclusion
Absence / presence of genetic polymorphisms --other (Including FUT2- and FUT3-)
Measured: Six months after inclusion
Absence / presence of different viral strains Rotavirus (RVA) involved in the acute gastroenteritis episodes in French Guiana
Measured: Six months after inclusion
Absence / presence of various HBGA polymorphisms involved in acute gastroenteritis episodes in French Guiana
Measured: Six months after inclusion
population frequency of different etiologies of acute gastroenteritis viral, bacterial and / or parasitic (Cayenne)
Measured: Six months after inclusion
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Sep 2016 (estimated)
- Study start28 Feb 2017
- Primary completion15 Oct 2020
- Study completion15 Oct 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for GastroenteritisStudies of the same condition, open and under way.
- More trials run by Nantes University HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 611 participants (actual)
Sponsor and investigators
- Lead sponsor
- Nantes University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Christèle GRAS-LEGUEN, MD PhD, Principal investigator, Nantes University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02902445
- Sponsor's protocol ID
- RC15_0329
- Acronym
- Gastrovimc
- Status last verified
- Apr 2021
- First submitted
- 12 Sep 2016
- Last updated
- 11 Apr 2022
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 11 Apr 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Glycan Attachment Specificity, Toward ROtavirus Vaccine IMprovement GASTROVIMc (Clinical Investigation) Evaluation of Individual Genetic Susceptibility in Severe Gastro-enteritis Rotavirus: Role of HBGA Polymorphisms & Biotechnology Improvement of RVA Vaccines
- ClinicalTrials.gov ID
- NCT02902445
- Acronym / sponsor ID
- Gastrovimc / RC15_0329
- Conditions
- Gastroenteritis, Acute Gastroenteritis
- Keywords
- Vaccine, Polymorphism
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 611 participants (actual)
- Lead sponsor
- Nantes University HospitalUniversity, hospital or other
- Study start
- 28 Feb 2017 (actual)
- Primary completion
- 15 Oct 2020 (actual)
- Study completion
- 15 Oct 2020 (actual)
- First posted
- 15 Sep 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
The work will be carried out in France and in a tropical area of population with diverse geographical origins: the Guyana populated with Native Americans, people of European descent, people of Asian (Hmong) and a large source population African.
The first aim of the project will be to characterize the specificity of the VP8 * HBGA of RotaTeq and Rotarix vaccines in order to ensure their binding characteristics glycans are similar to those of recent P8 clinical strains circulating in France and were maintained in the culture passages.
The second objective will be to validate the impact of recently described polymorphisms HBGAs on susceptibility to infection by RVA through GASTROVIMc prospective clinical research.
The third objective will be to determine the relative role of recognition and HBGAs ganglioside in the initial attachment and viral entry.
The expression of HBGAs and ganglioside by permissive cell lines in culture human stem RVA be manipulated to define the role of glycans in attachment and infection.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Case group | – | Biological: rotavirus rapid screen test, Genetic: polymorphism exploration250 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 |
| Control group | – | Genetic: polymorphism exploration250 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 |
Who may qualify
- Ages
- Up to 16 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- 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
Key inclusion criteria (4 listed)
- 0 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)
Key exclusion criteria (2 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| rotavirus rapid screen testAccording to routine care | Biological | Case group |
| polymorphism explorationfrom an oral swab collected after parents consent | Genetic | Case group, Control group |
Primary outcome
Absence / Presence of non-secretory polymorphisms FUT2- and Lewis Negative FUT3-
Time frame: 6 months after inclusion
5 secondary outcomes
Population frequency of new protective genotypes to rotavirus infection
Time frame: Six months after inclusion
Absence / presence of genetic polymorphisms --other (Including FUT2- and FUT3-)
Time frame: Six months after inclusion
Absence / presence of different viral strains Rotavirus (RVA) involved in the acute gastroenteritis episodes in French Guiana
Time frame: Six months after inclusion
Absence / presence of various HBGA polymorphisms involved in acute gastroenteritis episodes in French Guiana
Time frame: Six months after inclusion
population frequency of different etiologies of acute gastroenteritis viral, bacterial and / or parasitic (Cayenne)
Time frame: Six months after inclusion
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Apr 2022.
- Individual participant dataSharing planned: Undecided
Related trials for Gastroenteritis
Not yet recruitingPhase 1
An Open-label, DDI Study to Investigate the Effects of Duvakitug on the PK of Selected Cytochrome P450 Substrates
Ulcerative Colitis, Crohn's Disease
RecruitingObservational study
Longitudinal Immunophenotyping of Patients With Inflammatory Bowel Disease
Inflammatory Bowel Disease, Crohn's Disease
Recruiting
Study of the Influence of Intraperitoneal Insufflation of CO2 by Laparoscopy on the Short-term Evolution of Premature Infants With Ulcerative Necrotizing Enterocolitis
Preterm Birth, Enterocolitis, Necrotizing
RecruitingObservational study
Ibd CAncer and seRious Infections in France (I-CARE 2)
IBD, Ulcerative Colitis
RecruitingObservational study
Multidimensional Dynamic Early Warning System for Neonatal Necrotizing Enterocolitis: A Multicenter Clinical Study
NEC - Necrotizing Enterocolitis
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Christèle GRAS-LEGUEN, MD PhD principal investigator
Nantes University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Gastroenteritis and Acute Gastroenteritis, run by Nantes University Hospital at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 11 Apr 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Absence / Presence of non-secretory polymorphisms FUT2- and Lewis Negative FUT3- (time frame: 6 months after inclusion). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Apr 2022.