COmparison of MicroBiota AccordIng to Age in Crohn's Disease (COMeBACk)

NCT02839317 | Completed

• 2 other identifiers: 2013_712014-A01225-42
• Study Type: observational
• Target: 214
• Locations: 1 country
• Sites: 5

Brief 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. 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).

Conditions

Crohn's Disease

Keywords

Dysbiosis; Crohn's disease; Age

Outcome Measures

Primary Outcomes (1)

• 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).

  1 YEAR

Secondary Outcomes (4)

• Specific bacteria

  1 YEAR

• Association between bacterial dysbiosis and different genetic backgrounds

  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)

  1 YEAR

• Environmental risk factors

  1 YEAR

Study Arms (4)

Biological in pediatric CD

75 pediatric-onset CD Biological

Biological: Biological

Biological in pediatric controls

75 pediatric controls matched on gender, age and area of residence Biological

Biological: Biological

Biological in elderly CD

75 elderly-onset CD Biological

Biological: Biological

Biological in elderly controls

75 elderly controls matched on gender, age and area of residence Biological

Biological: Biological

Interventions

Biological BIOLOGICAL

comparison of microbiota, genetic profile between pediatric- and elderly-onset CD

Also known as: Dysbiosis

Biological in elderly CD; Biological in elderly controls; Biological in pediatric CD; Biological in pediatric controls

Eligibility Criteria

• Age: 8 Years - 80 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

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.

You may qualify if:

• 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.
• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• University Hospital, Lille: lead
• National Research Agency, France: collaborator

Study Sites (5)

Amiens University & Hospital

Amiens, 80000, France

Location

Lille Hôpital Huriez

Lille, 59037, France

Location

Lille Jean de Flandre Hospital

Lille, 59037, France

Location

Lille University Hospital & EPIMAD Registry

Lille, 59037, France

Location

Rouen University & Hospital

Rouen, 76000, France

Location

Biospecimen

Retention: SAMPLES WITH DNA

Stool samples Blood samples (DNA extraction) and sera Salivary samples

MeSH Terms

Conditions

Crohn Disease; Dysbiosis

Interventions

Biological Products

Condition Hierarchy (Ancestors)

Inflammatory Bowel Diseases; Gastroenteritis; Gastrointestinal Diseases; Digestive System Diseases; Intestinal Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Complex Mixtures

Study Officials

• Corinne Gower-Rousseau, MD, PhD

  University Hospital, Lille

  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: July 13, 2016
• First Posted: July 20, 2016
• Study Start: May 9, 2016
• Primary Completion: December 22, 2022
• Study Completion: December 22, 2022
• Last Updated: December 16, 2025

Record last verified: 2025-12

Locations

FR (5)