Evaluation of the Lymphocyte Subpopulations in the Normal Mucosa of the Upper Digestive Tract

NCT05084807 | Unknown

• 1 other identifier: GUT2020
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief Summary

The macro and microscopic findings of the upper gastrointestinal tract are useful in the differential diagnosis of digestive diseases such as Crohn's or celiac diseases. However, the histopathological findings (duodenal lymphocytosis, atrophy, chronic inflammatory infiltrate, etc.) are generally not pathognomonic, and there is a great overlap between different inflammatory diseases. The study of lymphocyte subpopulations of the intestine has shown its usefulness in cases of celiac disease that are difficult to diagnose. In patients with celiac disease, lymphocytes that infiltrate the duodenum present a specific pattern with increased percentage of TCRgẟ+ lymphocytes and reduced percentage of CD3- lymphocytes. However, it is currently unknown if other inflammatory diseases (e.g. Crohn's disease) have specific lymphocyte subpopulations that could be of great diagnostic aid. One of the main problems in establishing patterns associated with disease is the absence of immunological studies carried out in healthy individuals. Most of the studies include, as a control group, patients who undergo gastroscopy for the study of upper digestive symptoms and have microscopically normal duodenal biopsy. This is a heterogeneous population that includes, among others, patients with functional pathology in whom the existence of low-grade inflammatory phenomena has been suggested. Therefore, patients with digestive symptoms are not good controls to establish normal patterns of intestinal immunity.

Conditions

Lymphocytic Enteritis (Disorder); Healthy Volunteers

Keywords

Intraepithelial Lymphocytes; Intraepithelial T Cells; Celiac Disease; Crohn Disease; Healthy Volunteers

Outcome Measures

Primary Outcomes (1)

• Percentage of the lymphocyte subpopulations of the upper digestive tract as assessed by flow cytometry in asymptomatic healthy subjects with normal mucosa.

  During gastroscopy, samples of normal mucosa will be taken for histological and lymphocyte subpopulations analysis. The percentage of lymphocyte subpopulations will be assessed by flow cytometry.

  4 hour

Secondary Outcomes (1)

• Comparison the percentage of the pattern of lymphocyte subpopulations in the duodenum in relation to age and sex.

  4 hour

Study Arms (1)

Healthy group

OTHER

A group of healthy, strictly asymptomatic individuals of both sexes and different age groups.

Other: Endoscopy

Interventions

Endoscopy OTHER

* A dyspepsia test will be performed to avoid selection bias. In subjects strictly asymptomatic, a blood analysis will be proposed. * Subjects who present strictly normal laboratory tests (including celiac serology and negative H Pylori tests) and no genetic risk of celiac disease will be invited to perform an upper gastrointestinal endoscopy. * During gastroscopy, samples of normal mucosa will be taken for histological and lymphocyte subpopulations analysis. The percentage of lymphocyte subpopulations will be assessed by flow cytometry. * To compare whether there are differences between the lymphocyte subpopulations related to the age and sex of the healthy individuals, a student's t test, ANOVA or the corresponding non-parametric test will be used. The values will be expressed according to: mean +/- 2DS or median and interquartile range.

Healthy group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Adult individuals without any comorbidity, strictly asymptomatic.
• Age\> 18 years.
• Informed consent signature.
• Carrying out a varied, non-restrictive diet.
• Negative blood tests including celiac serology, H. pylori serology and celiac disease genetic study (will only be accepted if they have positive DQ2.2 allele).
• Normal esophagogastroduodenoscopy.
• Grossly and microscopic normal duodenal mucosa.

You may not qualify if:

• Refusal of the individual to participate.
• Severe disease (heart disease, lung disease, liver disease, bleeding disorders, neoplasms, etc.).
• Personal history of celiac disease and / or inflammatory bowel disease.
• Pregnancy and/or lactation.
• Age\> 45 years.
• BMI\> 28.
• Presence of any current digestive symptoms (negative responses must be met in all items of the dyspepsia test).
• Family history of 1st or 2nd degree of celiac disease or inflammatory bowel disease.
• Potentially contagious diseases (HIV, HCV, HBV, tuberculosis, Covid19, ...).
• Trips to tropical countries in the last 6 months.
• Presence of coagulopathy or use of anticoagulant treatments.
• Consumption of any drug (including NSAIDs) in the last 4 weeks.
• Strict vegetarian, vegan or gluten-free diet.
• H. pylori positive.
• DQ2.5 positive and /or DQ8 positive

Sponsors & Collaborators

• Hospital Mutua de Terrassa: lead

Study Sites (1)

Hospital Universitari Mutua Terrassa

Terrassa, Barcelona, 08221, Spain

RECRUITING

MeSH Terms

Conditions

Celiac Disease; Crohn Disease

Interventions

Endoscopy

Condition Hierarchy (Ancestors)

Malabsorption Syndromes; Intestinal Diseases; Gastrointestinal Diseases; Digestive System Diseases; Metabolic Diseases; Nutritional and Metabolic Diseases; Inflammatory Bowel Diseases; Gastroenteritis

Intervention Hierarchy (Ancestors)

Diagnostic Techniques, Surgical; Diagnostic Techniques and Procedures; Diagnosis; Minimally Invasive Surgical Procedures; Surgical Procedures, Operative

Study Officials

• Maria Esteve, PhD, MD

  Hospital Universitari Mútua Terrassa

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Albert Martin-Cardona, MD

CONTACT

+34937365050; martincardona@gmail.com

Maria Esteve, PhD, MD

CONTACT

+34937365050; mestevecomas@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Study Type: descriptive cross-sectional study, prospective. Estimated enrollment: 20 individuals. Estimated duration of the project: 12 months.

Study Record Dates

• First Submitted: September 28, 2021
• First Posted: October 20, 2021
• Study Start: June 1, 2021
• Primary Completion: June 1, 2022
• Study Completion: December 31, 2022
• Last Updated: October 20, 2021

Record last verified: 2021-10

Data Sharing

• IPD Sharing: Will not share

Locations

ES (1)