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NCT Number: NCT05704413

Digestive Biobank for Exploring Microbiota-host Interactions

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.

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Key information

Conditions

Inflammatory Bowel Diseases Colitis Colitis, Ulcerative Colonic Diseases Colorectal Cancer Colorectal Neoplasms Crohn Disease Digestive System Diseases Digestive System Neoplasms Gastroenteritis Gastrointestinal Diseases Gastrointestinal Neoplasms Indeterminate Colitis Intestinal Diseases Intestinal Neoplasms Mental Disorders Mood Disorders Neoplasms Neoplasms by Site Rectal Diseases Ulcerative Colitis

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

  • Patients < 18 years

Treatment and study plan

Primary outcomes

  1. Relation between biological parameters and outcomes of digestive disease (IBD, CRC)

    Time frame: up to 12 months after the incusion

    identify relations between serumon response to treatment, postoperative outcomes including neuro-cognitive and mood complications and prognosis.

Secondary outcomes

  1. Relation between biological parameters and outcomes of digestive disease (IBD, CRC)

    Time frame: up to 12 months after the incusion

    identify relations between plasma on response to treatment, postoperative outcomes including neuro-cognitive and mood complications and prognosis.

  2. Relation between biological parameters and outcomes of digestive disease (IBD, CRC)

    Time frame: up to 12 months after the incusion

    identify relations between DNA on response to treatment, postoperative outcomes including neuro-cognitive and mood complications and prognosis.

  3. Relation between biological parameters and outcomes of digestive disease (IBD, CRC)

    Time frame: up to 12 months after the incusion

    identify relations between faeces) on response to treatment, postoperative outcomes including neuro-cognitive and mood complications and prognosis.

  4. Exploratory study on the physiopathology of host-microbiota interactions to determinate the occurrence of intestinal and extra-intestinal complications

    Time frame: up to two months after the incusion

    genetic polymorphisms, serum markers, intestinal microbiota markers to determining the occurrence of intestinal and extra-intestinal complications

  5. Exploratory study on the physiopathology of host-microbiota interactions to determinate the response to treatments

    Time frame: up to two months after the incusion

    genetic polymorphisms, serum markers, intestinal microbiota markers determining : response to treatments

  6. Exploratory study on the physiopathology of host-microbiota interactions

    Time frame: up to two months after the incusion

    genetic polymorphisms, serum markers, intestinal microbiota markers determining : interactions between host and microbiota

  7. Brain-microbiota interaction

    Time frame: up to two months after the incusion

    Exploring the pathophysiology of host-microbiota interactions in postoperative cognitive or behavioral changes involving inflammation pathways

Study contacts

Contact information is provided by the study sponsor or research team.

Harry SOKOL, PU-PH

CONTACT

[email protected]

+33 (0)1 49 28 31 71

Jérémie LEFEVRE, PU-PH

CONTACT

[email protected]

+33 (0)1 49 28 25 63

Sponsors and collaborators

Lead sponsor

Assistance Publique - Hôpitaux de Paris

Other

Registry information

Acronym: BiomHost

Important dates

Study start
2021
Primary completion
2026
Study completion
2026
First posted
Jan 30, 2023
Registry last updated
Jan 30, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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