MESENCROHN: Mesenteric Bacterial Translocation in Evolved Crohn's Disease

Hospital Mutua de Terrassa (Other)
Overall Status
Recruiting ID

Study Details

Study Description

Brief Summary

Mesenteric fat can be invaded by gut bacteria through a process called bacterial translocation, which is the invasion of viable bacteria from the gastrointestinal tract to extraintestinal sites (mesenteric lymph nodes, liver, spleen, kidney, bloodstream, etc.). In Crohn's disease (CD), bacterial translocation could increase the disproportionate inflammatory response already present and contribute to disease progression by stimulating the production of pro-inflammatory cytokines and immune-cell infiltration in the mesentery. Several mechanisms may promote bacterial translocation, such as bacterial overgrowth, disruption of the intestinal mucosal barrier and alterations in the immune system.

Ileocecal surgical resection is required in some patients with complicated or refractory CD. Unfortunately, post-surgical disease recurrence happens in up to 40% of cases, probably defining a subgroup of CD patients with a particular aggressive form of the disease. The complete microbiome (in gastrointestinal and extraintestinal sites) in CD patients that develop early post-surgical recurrence, as well as the association to innate immunity alterations, has not yet been studied.

The primary aim of the study is to explore the bacterial microbiome of CD patients and its association with early post-surgical recurrence and clinical or genetic variables related to innate immunity. To achieve this, the bacterial DNA present in mesenteric fat and ileal tissue (inflamed and non-inflamed) from surgical resection samples as well as blood samples from CD patients will be studied. Genetic polymorphisms, relevant clinical data and disease recurrence will also be evaluated.

The investigators hypothesize that bacterial translocation to the mesentery fat near the inflamed intestine is one of the mechanisms for perpetuation and chronicity of inflammation and therefore post-surgical recurrence in CD. The investigators expect to find a distinctive bacterial profile (in quantity and quality) in the mesenteric fat of patients with early post-surgical recurrence and/or with genetic variants that cause alterations in innate immunity.

The study of the microbiome in CD could help to identify the patients with a more aggressive disease form that will probably present early post-surgical recurrence, and could raise the possibility of microbial modulation as therapy for CD.

Condition or Disease Intervention/Treatment Phase

    Study Design

    Study Type:
    Anticipated Enrollment :
    40 participants
    Observational Model:
    Time Perspective:
    Official Title:
    Mesenteric Bacterial Translocation in Evolved Crohn's Disease
    Actual Study Start Date :
    Jul 1, 2022
    Anticipated Primary Completion Date :
    Jul 1, 2024
    Anticipated Study Completion Date :
    Dec 1, 2025

    Arms and Interventions

    Arm Intervention/Treatment
    CD patients requiring surgical treatment (ileocecal resection)

    Control group

    Patients requiring an ileocecal resection for a cause other than CD

    Outcome Measures

    Primary Outcome Measures

    1. Predictive power of the bacterial microbiome profile over early post-surgical disease recurrence in CD patients [at inclusion (surgery) + additional study of bacterial DNA in blood at 3 months in CD patients)]

      Characterization of the microbiota present in the mesentery, ileal tissue and blood.

    Secondary Outcome Measures

    1. Association analysis of genetic variants related to innate immunity and the bacterial microbiome profile of CD patients [at inclusion (surgery)]

      DNA polymorphisms detection in blood: ATG16L1 (rs2241880, rs3792109, rs3828309); NOD2 / CARD15 (rs2066844, rs2066845) and IRGM (rs13361189, rs4958847, rs1336119, rs10065172, rs7714584).

    Eligibility Criteria


    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    Accepts Healthy Volunteers:
    Inclusion Criteria:
    • Adults (18 years or older)

    • Informed consent signed

    • To require an ileocecal resection as part of the treatment of Crohn's Disease

    • In the case of controls: not having Inflammatory Bowel Disease and requiring an ileocecal resection for another reason

    Exclusion Criteria:
    • To require an ileocecal resection with definitive or transient ileostomy

    • In the case of controls: existence of a family history of Inflammatory Bowel Disease.

    Contacts and Locations


    Site City State Country Postal Code
    1 Hospital Universitari MĂștuaTerrassa Terrassa Barcelona Spain 08221

    Sponsors and Collaborators

    • Hospital Mutua de Terrassa


    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information


    Responsible Party:
    Hospital Mutua de Terrassa Identifier:
    Other Study ID Numbers:
    First Posted:
    Jun 7, 2023
    Last Update Posted:
    Jun 7, 2023
    Last Verified:
    May 1, 2023
    Studies a U.S. FDA-regulated Drug Product:
    Studies a U.S. FDA-regulated Device Product:
    Keywords provided by Hospital Mutua de Terrassa
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of Jun 7, 2023