Crohn's DiseaseCOMeBACkNCT02839317
COmparison of MicroBiota AccordIng to Age in Crohn's Disease (COMeBACk)
An observational study of Crohn's Disease, run by University Hospital, Lille at 5 sites in France.
Trial summary
The cause of CD could be different according to age at onset of CD symptoms. Indeed we know that some very young patients at CD diagnosis have particular genetic variants as abnormalities of the IL10R that are regarded as quite monogenic disease. Read more about this study
- Who is it for?
- Ages 8 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Crohn's Disease
- What is being tested?
- Biological
- How many people
- 214 participants
- Where
- 5 sitesFrance
- Study dates
- 9 May 2016to 22 Dec 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 8 to 80 years
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Study population: Paediatric- onset (n=75), elderly-onset CD patients (n=75) and control subjects matched on age, gender and geographical origin (urban, periurban and rural area according to INSEE data) in each group (n=150) will be recruited through a large population-based registry of IBD patients (EPIMAD Registry). In 2 case-control studies, controls (n=150) will be matched to cases by age (± 2 years), gender and geographical origin (urban, periurban and rural area according to INSEE data). Control subjects will be recruited through paediatric and geriatric consultations in Lille University Hospital. The duration of recruitment will be 2 years.
Who may be able to join
- CD patients Patients aged less than 17 years (paediatric-CD group) or more than 40 years (elderly-CD group) at definite or probable CD diagnosis, defined according to Epimad's criteria2,4.
- CD diagnosis within 5 years prior inclusion. Patients with CD in remission with or without corticosteroids, 5-ASA or nutrition.
- Agreeing to participate in the project and have signed consent, Being insured
- Control subjects Patients aged less than 17 years (paediatric-control group) or more than 40 years (elderly-control group) Agreeing to participate in the project and have signed consent, Being insured
Who cannot join
- Pregnant or lactating Subject who underwent bowel resection Subject taking antibiotics, prebiotics, probiotics or bowel preparation in 6 weeks sampling seat will be temporarily suspended. The sampling will be done remotely and delayed (> 6 weeks) of treatment discontinuation or antibiotic bowel preparation.
- A person taking or have taken a topical treatment within 6 weeks before inclusion Persons who have undergone surgical resection Nobody emergency Topic guardianship, curator ship or judicial protection, persons deprived of liberty Subject does not speak French Subject unable to answer questions or express
Trial locations and contacts
5 sites in 1 country.
5 sites in 1 country
France5 sites
Amiens University & Hospital
Amiens, 80000
Lille Hôpital Huriez
Lille, 59037
Lille Jean de Flandre Hospital
Lille, 59037
Lille University Hospital & EPIMAD Registry
Lille, 59037
Rouen University & Hospital
Rouen, 76000
About this study
Official title: Comparison of Fecal Microbiota Between Patients With Early and Late Crohn's Disease and Relationship With Different Genetic and Serological Profiles
The cause of CD could be different according to age at onset of CD symptoms. Indeed we know that some very young patients at CD diagnosis have particular genetic variants as abnormalities of the IL10R that are regarded as quite monogenic disease. In the other way, the microbiota also undergoes substantial changes at the extremes of life, in infants and older people and the ramifications of which are very few being explored. The comparison of microbiota by principal component analysis and genetic profile of patients with CD beginning at the extremes of life could help us to better known physiopathology of CD according to age and provide arguments that CD beginning at the extremes of life could be different diseases.
The aim of the study is to ascertain through population-based study the hypothesis that gut microbiota is different between paediatric-onset and elderly-onset CD patients in relation with genetic and environmental mechanisms. The results will provide a better knowledge of the etiopathogenic ways in CD and propose a personalized therapeutic care based on age at CD onset (i.e. according to the gut bacteria involved).
Read the detailed description
The primary aim is to describe by principal component analysis and compare the gut microbiota between subgroups of paediatric-onset (n=75), elderly-onset CD patients (n=75) and control subjects (75 paediatric control and 75 elderly control subjects matched on age) without an a priori approach of high throughput sequencing of bacterial DNA. As it has been shown that the type of IBD-associated dysbiosis depends on ileal involvement, Paediatric-onset and elderly-onset CD patients will be stratified according this parameter.
The secondary aims are:
- (I) Find specific bacteria involved in paediatric- and elderly-onset patients using PLS Discriminant Analysis (PLS-DA) that is a classical PLS regression (with a regression mode) but where the response variable is categorical.
- (II) Search for an association between bacterial dysbiosis and different genetic backgrounds in patients according to age at CD onset (paediatric-onset vs elderly-onset) and in control subjects;
- (III) Quantify of bacteria with invasive properties (E. coli, including adherent-invasive E.coli, Shigella, Salmonella, Yersinia, Campylobacter), and fecal fungal flora (Candida albicans, in particular) and their association with genetic and serological profiles according to age at CD onset and in control subjects; this study will include the comparison of the gut microbiome between subgroups of paediatric-onset, elderly-onset CD patients and control subjects.
- (IV) Study of environmental risk factors using a questionnaire to be submitted to CD patients and control subjects.
The results would provide a better knowledge of the etiopathogenic ways in CD and would downstream open the way towards clinical trials focused on specific microbiota disorders according to age at CD onset. This project will help to decipher the potential involvement of specific bacteria in the physiopathology of CD. This could lead to the development of new therapeutic strategies either using optimized current treatments targeting bacteria. Data from clinical trials which for the great majority rarely include paediatric patients and set an upper limit for study eligibility at 65 years of age are thus focusing on adult-onset disease. Thus the potential specificities of paediatric- and elderly-onset diseases are not taken into account. A better knowledge of characteristics of CD at the extreme of life will be important to set up innovative clinical trials including specific therapeutics adapted to patients where disease occurred at the extreme age of life, especially as these patients did not benefited of specific trials. The ultimate goal is a better quality of care delivered to paediatric- and elderly-onset CD patients.
- Conditions
- Crohn's Disease
- Being tested
- Biological
- Keywords
- Dysbiosis, Crohn's disease, Age
- Medical subject headings
- Crohn Disease, Dysbiosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BiologicalBiological
Also called Dysbiosis
comparison of microbiota, genetic profile between pediatric- and elderly-onset CD
| Study group | Role | What they receive |
|---|---|---|
| Biological in pediatric CD | 75 pediatric-onset CD Biological Receives: Biological: Biological | |
| Biological in pediatric controls | 75 pediatric controls matched on gender, age and area of residence Biological Receives: Biological: Biological | |
| Biological in elderly CD | 75 elderly-onset CD Biological Receives: Biological: Biological | |
| Biological in elderly controls | 75 elderly controls matched on gender, age and area of residence Biological Receives: Biological: Biological |
What is being measured
The primary outcome is the main question the study is designed to answer.
Analysis of microbiota
To describe by principal component analysis and compare the gut microbiota between subgroups of paediatric-onset (n=75), elderly-onset CD patients (n=75) and controls (150).
Measured: 1 YEAR
Secondary outcomes (4)
Specific bacteria
Find specific bacteria involved in paediatric- and elderly-onset patients using PLS Discriminant Analysis (PLS-DA)
Measured: 1 YEAR
Association between bacterial dysbiosis and different genetic backgrounds
Search for an association between bacterial dysbiosis and different genetic backgrounds in patients according to age at CD onset (paediatric-onset vs elderly-onset) and in controls
Measured: 1 YEAR
Presence of bacteria with invasive properties (E. coli, including adherent-invasive E.coli, Shigella, Salmonella, Yersinia, Campylobacter), and fecal fungal flora (Candida albicans, in particular)
Quantify of bacteria with invasive properties (E. coli, including adherent-invasive E.coli, Shigella, Salmonella, Yersinia, Campylobacter), and fecal fungal flora (Candida albicans, in particular)
Measured: 1 YEAR
Environmental risk factors
Study of environmental risk factors using a questionnaire to be submitted to CD patients and controls .
Measured: 1 YEAR
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jul 2016 (estimated)
- Study start9 May 2016
- Primary completion22 Dec 2022
- Study completion22 Dec 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Crohn's DiseaseStudies of the same condition, open and under way.
- More trials run by University Hospital, LilleThe 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
- 214 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Lille
- Sponsor type
- University, hospital or other
- Collaborators
- National Research Agency, France
- Responsible party
- Sponsor
- Investigators
- Corinne Gower-Rousseau, MD, PhD, Principal investigator, University Hospital, Lille
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02839317
- Sponsor's protocol ID
- 2013_71
- Other IDs
- 2014-A01225-42
- Acronym
- COMeBACk
- Status last verified
- Dec 2025
- First submitted
- 13 Jul 2016
- Last updated
- 16 Dec 2025
- 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 16 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Fecal Microbiota Between Patients With Early and Late Crohn's Disease and Relationship With Different Genetic and Serological Profiles
- ClinicalTrials.gov ID
- NCT02839317
- Acronym / sponsor ID
- COMeBACk / 2013_71
- Conditions
- Crohn's Disease
- Keywords
- Dysbiosis, Crohn's disease, Age
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 214 participants (actual)
- Lead sponsor
- University Hospital, LilleUniversity, hospital or other
- Collaborators
- National Research Agency, France
- Study start
- 9 May 2016 (actual)
- Primary completion
- 22 Dec 2022 (actual)
- Study completion
- 22 Dec 2022 (actual)
- First posted
- 20 Jul 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 cause of CD could be different according to age at onset of CD symptoms. Indeed we know that some very young patients at CD diagnosis have particular genetic variants as abnormalities of the IL10R that are regarded as quite monogenic disease. In the other way, the microbiota also undergoes substantial changes at the extremes of life, in infants and older people and the ramifications of which are very few being explored. The comparison of microbiota by principal component analysis and genetic profile of patients with CD beginning at the extremes of life could help us to better known physiopathology of CD according to age and provide arguments that CD beginning at the extremes of life could be different diseases.
The aim of the study is to ascertain through population-based study the hypothesis that gut microbiota is different between paediatric-onset and elderly-onset CD patients in relation with genetic and environmental mechanisms. The results will provide a better knowledge of the etiopathogenic ways in CD and propose a personalized therapeutic care based on age at CD onset (i.e. according to the gut bacteria involved).
Detailed description
The primary aim is to describe by principal component analysis and compare the gut microbiota between subgroups of paediatric-onset (n=75), elderly-onset CD patients (n=75) and control subjects (75 paediatric control and 75 elderly control subjects matched on age) without an a priori approach of high throughput sequencing of bacterial DNA. As it has been shown that the type of IBD-associated dysbiosis depends on ileal involvement, Paediatric-onset and elderly-onset CD patients will be stratified according this parameter.
The secondary aims are:
- (I) Find specific bacteria involved in paediatric- and elderly-onset patients using PLS Discriminant Analysis (PLS-DA) that is a classical PLS regression (with a regression mode) but where the response variable is categorical.
- (II) Search for an association between bacterial dysbiosis and different genetic backgrounds in patients according to age at CD onset (paediatric-onset vs elderly-onset) and in control subjects;
- (III) Quantify of bacteria with invasive properties (E. coli, including adherent-invasive E.coli, Shigella, Salmonella, Yersinia, Campylobacter), and fecal fungal flora (Candida albicans, in particular) and their association with genetic and serological profiles according to age at CD onset and in control subjects; this study will include the comparison of the gut microbiome between subgroups of paediatric-onset, elderly-onset CD patients and control subjects.
- (IV) Study of environmental risk factors using a questionnaire to be submitted to CD patients and control subjects.
The results would provide a better knowledge of the etiopathogenic ways in CD and would downstream open the way towards clinical trials focused on specific microbiota disorders according to age at CD onset. This project will help to decipher the potential involvement of specific bacteria in the physiopathology of CD. This could lead to the development of new therapeutic strategies either using optimized current treatments targeting bacteria. Data from clinical trials which for the great majority rarely include paediatric patients and set an upper limit for study eligibility at 65 years of age are thus focusing on adult-onset disease. Thus the potential specificities of paediatric- and elderly-onset diseases are not taken into account. A better knowledge of characteristics of CD at the extreme of life will be important to set up innovative clinical trials including specific therapeutics adapted to patients where disease occurred at the extreme age of life, especially as these patients did not benefited of specific trials. The ultimate goal is a better quality of care delivered to paediatric- and elderly-onset CD patients.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Biological in pediatric CD | – | Biological: Biological75 pediatric-onset CD Biological |
| Biological in pediatric controls | – | Biological: Biological75 pediatric controls matched on gender, age and area of residence Biological |
| Biological in elderly CD | – | Biological: Biological75 elderly-onset CD Biological |
| Biological in elderly controls | – | Biological: Biological75 elderly controls matched on gender, age and area of residence Biological |
Who may qualify
- Ages
- 8 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Paediatric- onset (n=75), elderly-onset CD patients (n=75) and control subjects matched on age, gender and geographical origin (urban, periurban and rural area according to INSEE data) in each group (n=150) will be recruited through a large population-based registry of IBD patients (EPIMAD Registry). In 2 case-control studies, controls (n=150) will be matched to cases by age (± 2 years), gender and geographical origin (urban, periurban and rural area according to INSEE data). Control subjects will be recruited through paediatric and geriatric consultations in Lille University Hospital. The duration of recruitment will be 2 years.
Key inclusion criteria (4 listed)
- CD patients Patients aged less than 17 years (paediatric-CD group) or more than 40 years (elderly-CD group) at definite or probable CD diagnosis, defined according to Epimad's criteria2,4.
- CD diagnosis within 5 years prior inclusion. Patients with CD in remission with or without corticosteroids, 5-ASA or nutrition.
- Agreeing to participate in the project and have signed consent, Being insured
- Control subjects Patients aged less than 17 years (paediatric-control group) or more than 40 years (elderly-control group) Agreeing to participate in the project and have signed consent, Being insured
Key exclusion criteria (2 listed)
- Pregnant or lactating Subject who underwent bowel resection Subject taking antibiotics, prebiotics, probiotics or bowel preparation in 6 weeks sampling seat will be temporarily suspended. The sampling will be done remotely and delayed (> 6 weeks) of treatment discontinuation or antibiotic bowel preparation.
- A person taking or have taken a topical treatment within 6 weeks before inclusion Persons who have undergone surgical resection Nobody emergency Topic guardianship, curator ship or judicial protection, persons deprived of liberty Subject does not speak French Subject unable to answer questions or express
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 |
|---|---|---|
| BiologicalAlso: Dysbiosiscomparison of microbiota, genetic profile between pediatric- and elderly-onset CD | Biological | Biological in elderly CD, Biological in elderly controls, Biological in pediatric CD, Biological in pediatric controls |
Primary outcome
Analysis of microbiota
Time frame: 1 YEAR
To describe by principal component analysis and compare the gut microbiota between subgroups of paediatric-onset (n=75), elderly-onset CD patients (n=75) and controls (150).
4 secondary outcomes
Specific bacteria
Time frame: 1 YEAR
Association between bacterial dysbiosis and different genetic backgrounds
Time frame: 1 YEAR
Presence of bacteria with invasive properties (E. coli, including adherent-invasive E.coli, Shigella, Salmonella, Yersinia, Campylobacter), and fecal fungal flora (Candida albicans, in particular)
Time frame: 1 YEAR
Environmental risk factors
Time frame: 1 YEAR
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 16 Dec 2025.
- Individual participant dataSharing planned: Undecided
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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.
Corinne Gower-Rousseau, MD, PhD principal investigator
University Hospital, Lille
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Crohn's Disease, run by University Hospital, Lille at 5 sites 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 16 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites 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?
Analysis of microbiota (time frame: 1 YEAR). 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 16 Dec 2025.