GE-ID study Gastro-intestinal Expression profiles in Immune-mediated Diseases study. An explorative study for tissue specific patterns in inflammatory diseases of the gastrointestinal tract

GE-ID study Gastro-intestinal Expression profiles in Immune-mediated Diseases study. An explorative study for tissue specific patterns in inflammatory diseases of the gastrointestinal tract - GE-ID study

Status

Recruiting

Phases

Unknown

Study type

Observational

Source

NL-OMON

Registry ID

NL-OMON47023

Enrollment

600

Registered

2016-11-21

Start date

2017-02-15

Completion date

Unknown

Last updated

2024-06-18

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

Conditions

Inflammatory bowel disease - Crohns disease or ulcerative colitis

Interventions

None listed

Eligibility

Age

18 Years to 99 Years

Inclusion criteria

Inclusion criteria: - Written informed consent - >= 18- years old at time of signing informed consent - Must understand and voluntarily sign an informed consent document prior to any study related assessments/procedures being conducted. - Must be able to adhere to the study visit schedule and other protocol requirements;At least one of the following; - Patients suffering from CD or UC diagnosed by the treating physician according to established clinical, serological and pathological definitions, who are planned for routine diagnostic endoscopy. - Patients with suspected IBS according the treating physician, who are planned for routine diagnostic endoscopy - Patients planned for routine screening/follow-up endoscopy for colorectal carcinoma and or adenomatous polyps. - Patients who are suffering from intestinal inflammatory disorders other than IBD (including but not limited to celiac disease or graft-versus-host-disease), who are planned for routine diagnostic endoscopy.

Exclusion criteria

Exclusion criteria: - No informed consent obtained for this study - Severe psychiatric or physical illness - Not being able to understand Dutch language - Pregnancy - Patients on therapeutic anticoagulants and therefore not qualifying for routine endoscopic procedures according to current national guidelines

Design outcomes

Primary

Measure	Time frame
Aims: The primary aim of the currently proposed research is to get a better understanding of how functional genetic variants influence the immune system of the gastrointestinal tract. To achieve this, we will apply a holistic approach using both transcriptome and microbiome data in the background of the genetic and phenotypic profile of each individual. To generate this information, we have to profile different cell types from patients and controls that are known to play a role in immune processes. We aim to study immune effector cells, fibroblasts and epithelial cells to get a better understanding of the role of these cells in inflammatory conditions. The datasets derived from cell-specific transcriptomic analyses and the microbiome, genome and phenotype data will be analyzed and integrated using bioinformatics to develop insights into disease mechanisms. Main study parameters/endpoints: We will perform sequence-based transcriptomics (RNAseq) to obtain profiles of all transcripts and correlate this to the microbiome composition, genetic, serological and phenotypic data. We will determine presence and functionality of the epithelial cells in organoids by (immuno)histochemical staining for enzyme activity, antimicrobial proteins and mucus production. Results will be compared between cases and controls.	—

Measure

Time frame

Aims: The primary aim of the currently proposed research is to get a better understanding of how functional genetic variants influence the immune system of the gastrointestinal tract. To achieve this, we will apply a holistic approach using both transcriptome and microbiome data in the background of the genetic and phenotypic profile of each individual. To generate this information, we have to profile different cell types from patients and controls that are known to play a role in immune processes. We aim to study immune effector cells, fibroblasts and epithelial cells to get a better understanding of the role of these cells in inflammatory conditions. The datasets derived from cell-specific transcriptomic analyses and the microbiome, genome and phenotype data will be analyzed and integrated using bioinformatics to develop insights into disease mechanisms. Main study parameters/endpoints: We will perform sequence-based transcriptomics (RNAseq) to obtain profiles of all transcripts and correlate this to the microbiome composition, genetic, serological and phenotypic data. We will determine presence and functionality of the epithelial cells in organoids by (immuno)histochemical staining for enzyme activity, antimicrobial proteins and mucus production. Results will be compared between cases and controls.

—

Secondary

Measure	Time frame
The secondary aim is to construct and implement a patient-specific predictive instrument for severe disease course.	—

Countries

Netherlands

Outcome results