Evolution of Lymphocyte Populations Under Biotherapy in Inflammatory Bowel Disease

Status

UNKNOWN

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT02693340

Acronym

IBDOT

Enrollment

Registered

2016-02-26

Start date

2016-02-29

Completion date

2020-03-31

Last updated

2016-06-24

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

Conditions

Inflammatory Bowel Disease

Brief summary

This is a monocentric prospective study for the collection of biological samples (blood and biopsies) to be used for in vitro biomarker assay(s) performed to identify predictive markers of response to biological treatments in inflammatory bowel disease (IBD).

Interventions

BIOLOGICALsampling

• Sampling period(s): * Blood: W0, W6, W14, W30 and W52 and relapse. * Biopsies and fecal: W0, W14 and M52 and relapse.

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

Inclusion criteria

* Patients aged 18 or more. * Crohn's Disease Diagnosis (CD) or ulcerative colitis (UC) according to defined criteria (ECCO recommendations). * Active disease as defined by clinical biological and/or morphological assessment. * Initiation of an anti-Tumor Necrosis Factor (TNF) therapy (Infliximab, Adalimumab, Golimumab) or new biotherapy (Vedolizumab, Ustekinumab) provided in connection with the management of digestive disease. * Patient (e) have signed and dated consent of the study before undertaking procedures related to the study.

Exclusion criteria

* Patients under guardianship / curators * Following Situations * Persons unable to understand, read and / or sign an informed consent * Patient with the following functions: investigator or co-investigator, research assistant, pharmacist, study coordinator or having any involvement in the study * Uncooperative person or potentially non-compliant for the study and its procedures with predictable difficulties regular monitoring of over 1 year. * No affiliation to a social security scheme, a universal medical coverage or any similar plan. * Pregnant or lactating women.

Design outcomes

Primary

Measure	Time frame
Response to biological treatments	12 months

Secondary

Measure	Time frame
Microbiota variation	12 months

Countries

France

Contacts

Primary ContactMatthieu Allez, MDPhD

matthieu.allez@aphp.fr+33 1 42 49 95 97

Outcome results

None listed

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