Inflammatory Bowel DiseasesIVOIRENCT03967236
Impact of Intestinal Virome on Pediatric Inflammatory Bowel Disease
An observational study of Inflammatory Bowel Diseases, run by Hospices Civils de Lyon at 1 site in France.
Trial 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). Read more about this study
- Who is it for?
- Ages 6 to 17 years
- Conditions the study is for
- Inflammatory Bowel Diseases
- What is being tested?
- Collection of stool and blood samples
- How many people
- 20 participants
- Where
- 1 siteFrance
- Study dates
- 10 Jul 2019to 28 Feb 2022
- 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 6 to 17 years
- All sexes
- No healthy volunteers
- Child
Study population: Children with nflammatory bowel disease newly treated with anti-TNF therapy in the "Hôpital Femme Mère Enfant" center in Lyon
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
France1 site
Service de gastroentérologie nutrition, hépatologie pédiatrique - Hôpital Femme Mère Enfant groupement hospitalier Est - HCL
Bron, 69677
About this study
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
- Being tested
- Collection of stool and blood samples
- Medical subject headings
- Inflammatory Bowel Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Collection of stool and blood samplesOther
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.
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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
Measured: 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
Measured: at the inclusion, 6 months and one year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 May 2019
- Study start10 Jul 2019
- Primary completion28 Feb 2022
- Study completion28 Feb 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Inflammatory Bowel DiseasesStudies of the same condition, open and under way.
- More trials run by Hospices Civils de LyonThe 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hospices Civils de Lyon
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03967236
- Sponsor's protocol ID
- 69HCL18_0794
- Acronym
- IVOIRE
- Status last verified
- Nov 2022
- First submitted
- 23 May 2019
- Last updated
- 29 Nov 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Goens M, Mouton W, Oriol G, Cheynet V, Restier L, Bal A, Brengel-Pesce K, Rozieres A, Viret C, Nancey S, Faure M, Trouillet-Assant S, Duclaux-Loras R. Deep Characterisation of Circulating Torque Teno Virus DNA Load in Crohn's Disease Patients. J Med Virol. 2025 Jul;97(7):e70473. doi: 10.1002/jmv.70473.
PubMed 40586686
Study at a glance
From the registry record, last updated by the sponsor on 29 Nov 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of Intestinal Virome on Pediatric Inflammatory Bowel Disease
- ClinicalTrials.gov ID
- NCT03967236
- Acronym / sponsor ID
- IVOIRE / 69HCL18_0794
- Conditions
- Inflammatory Bowel Diseases
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Hospices Civils de LyonUniversity, hospital or other
- Study start
- 10 Jul 2019 (actual)
- Primary completion
- 28 Feb 2022 (actual)
- Study completion
- 28 Feb 2022 (actual)
- First posted
- 30 May 2019 (actual)
- 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.
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
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 6 to 17 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- Study population
- Children with nflammatory bowel disease newly treated with anti-TNF therapy in the "Hôpital Femme Mère Enfant" center in Lyon
Key inclusion criteria (6 listed)
- Age: 6-17 years
- Follow-up in pediatric gastroenterology for inflammatory bowel disease :
- 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
Key exclusion criteria (6 listed)
- 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)
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 |
|---|---|---|
| Collection of stool and blood samplesFor 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. | Other | – |
Primary outcome
Evaluation over time of change of the gut virome
Time frame: 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
Evaluation over time of change of the gut virome
Time frame: 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
Evaluation over time of change of the gut virome
Time frame: 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
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 29 Nov 2022.
- Derived from this study: PubMed 40586686Goens M, Mouton W, Oriol G, Cheynet V, Restier L, Bal A, Brengel-Pesce K, Rozieres A, Viret C, Nancey S, Faure M, Trouillet-Assant S, Duclaux-Loras R. Deep Characterisation of Circulating Torque Teno Virus DNA Load in Crohn's Disease Patients. J Med Virol. 2025 Jul;97(7):e70473. doi: 10.1002/jmv.70473.
- Individual participant dataSharing planned: No
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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.
The record lists no contact. Use the official record to reach the sponsor.
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 Inflammatory Bowel Diseases, run by Hospices Civils de Lyon 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 6 inclusion and 6 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 29 Nov 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?
Evaluation over time of change of the gut virome (time frame: at the inclusion, 6 months and one year). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03967236, which also lists 1 linked publication.
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 29 Nov 2022.