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Digestive Biobank for Exploring Microbiota-host Interactions

Digestive Biobank for Exploring Microbiota-host Interactions

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT05704413
Acronym
BiomHost
Enrollment
500
Registered
2023-01-30
Start date
2021-06-17
Completion date
2026-09-17
Last updated
2023-01-30

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Colorectal Cancer, Crohn Disease, Indeterminate Colitis, Inflammatory Bowel Diseases, Ulcerative Colitis

Keywords

Microbiota, inflammatory bowel disease, Crohn's disease, ulcerative colitis, colorectal cancer, post-operative cognitive disorders, mood disorders, immune system.

Brief summary

Constitution of a biobank of tissues, whole blood and plasma samples and stools to identify markers associated with treatment response, postoperative morbidity including neuro-cognitive and mood complications and prognosis of Inflammatory Bowel disease or colorectal cancer.

Detailed description

Inflammatory Bowel disease (Crohn, Ulcerative colitis) and colorectal cancer are frequent affections and the microbiota plays a major role in their physiopathology involving the immune system. In this setting, the interplay between gut microbiota and brain is still unexplored. To evaluate the interaction of the microbiota and the immune system with the host in these two chronic diseases, we aim to create a prospective biobank. A small amount of tissue will be taken during surgery. A whole blood, plasma and stoll samples will also be taken from the patient. All samples will be anonymized.

Interventions

None listed

Sponsors

Assistance Publique - Hôpitaux de Paris
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

* Ulcerative colitis, Crohn's disease or colorectal disease * Digestive resection with useless tissue available * Information consent signed

Exclusion criteria

\- Patients \< 18 years

Design outcomes

Primary

MeasureTime frameDescription
Relation between biological parameters and outcomes of digestive disease (IBD, CRC)up to 12 months after the incusionidentify relations between serumon response to treatment, postoperative outcomes including neuro-cognitive and mood complications and prognosis.

Secondary

MeasureTime frameDescription
Relation between biological parameters and outcomes of digestive disease (IBD, CRC)up to 12 months after the incusionidentify relations between plasma on response to treatment, postoperative outcomes including neuro-cognitive and mood complications and prognosis.
Exploratory study on the physiopathology of host-microbiota interactions to determinate the occurrence of intestinal and extra-intestinal complicationsup to two months after the incusiongenetic polymorphisms, serum markers, intestinal microbiota markers to determining the occurrence of intestinal and extra-intestinal complications
Exploratory study on the physiopathology of host-microbiota interactions to determinate the response to treatmentsup to two months after the incusiongenetic polymorphisms, serum markers, intestinal microbiota markers determining : response to treatments
Exploratory study on the physiopathology of host-microbiota interactionsup to two months after the incusiongenetic polymorphisms, serum markers, intestinal microbiota markers determining : interactions between host and microbiota
Brain-microbiota interactionup to two months after the incusionExploring the pathophysiology of host-microbiota interactions in postoperative cognitive or behavioral changes involving inflammation pathways

Countries

France

Contacts

Primary ContactJérémie LEFEVRE, PU-PH
jeremie.lefevre@aphp.fr+33 (0)1 49 28 25 63
Backup ContactHarry SOKOL, PU-PH
harry.sokol@aphp.fr+33 (0)1 49 28 31 71

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026