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Evaluation of the Lymphocyte Subpopulations in the Normal Mucosa of the Upper Digestive Tract (GUTproject)

Primary Purpose

Lymphocytic Enteritis (Disorder), Healthy Volunteers

Status

Unknown status

Phase

Not Applicable

Locations

Spain

Study Type

Interventional

Intervention

Endoscopy

About this trial

This is an interventional basic science trial for Lymphocytic Enteritis (Disorder) focused on measuring Intraepithelial Lymphocytes, Intraepithelial T Cells, Celiac Disease, Crohn Disease, Healthy Volunteers

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Study population: 20 healthy individuals, strictly asymptomatic, of both sexes, in different age groups will be included.

Inclusion Criteria:

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.

Exclusion Criteria:

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
Positive celiac serology (anti-transglutaminase> 2 U / mL).
Active smoking.
Habitual alcohol intake >40 g in men and 20 g in women.
Alcohol intake in the previous 3 days.
Esophagus-gastro-duodenoscopy with macroscopically abnormal mucosa.

Sites / Locations

Hospital Universitari Mutua TerrassaRecruiting

Arms of the Study

Arm 1

Arm Type

Other

Arm Label

Healthy group

Arm Description

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

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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

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.

Full Information

NCT ID

NCT05084807

First Posted

September 28, 2021

Last Updated

October 18, 2021

Sponsor

Hospital Mutua de Terrassa

1. Study Identification

Unique Protocol Identification Number

NCT05084807

Brief Title

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

Acronym

GUTproject

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

October 2021

Overall Recruitment Status

Unknown status

Study Start Date

June 1, 2021 (Actual)

Primary Completion Date

June 1, 2022 (Anticipated)

Study Completion Date

December 31, 2022 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Hospital Mutua de Terrassa

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

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.

Detailed Description

Hypothesis: The evaluation of the lymphocyte subpopulations of the subjects without digestive symptoms and normal upper digestive tract mucosa will allow to have a healthy control group with which to compare the cellular patterns of different chronic inflammatory diseases.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Lymphocytic Enteritis (Disorder), Healthy Volunteers

Keywords

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

7. Study Design

Primary Purpose

Basic Science

Study Phase

Not Applicable

Interventional Study Model

Single Group Assignment

Model Description

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

Masking

None (Open Label)

Allocation

N/A

Enrollment

20 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Healthy group

Arm Type

Other

Arm Description

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

Intervention Type

Other

Intervention Name(s)

Endoscopy

Intervention Description

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.

Primary Outcome Measure Information:

Title

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

Description

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.

Time Frame

4 hour

Secondary Outcome Measure Information:

Title

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

Description

Time Frame

4 hour

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

Study population: 20 healthy individuals, strictly asymptomatic, of both sexes, in different age groups will be included. Inclusion Criteria: 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. Exclusion Criteria: 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 Positive celiac serology (anti-transglutaminase> 2 U / mL). Active smoking. Habitual alcohol intake >40 g in men and 20 g in women. Alcohol intake in the previous 3 days. Esophagus-gastro-duodenoscopy with macroscopically abnormal mucosa.

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Albert Martin-Cardona, MD

Phone

+34937365050

Ext

60880

martincardona@gmail.com

First Name & Middle Initial & Last Name or Official Title & Degree

Maria Esteve, PhD, MD

Phone

+34937365050

Ext

11210

mestevecomas@gmail.com

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Maria Esteve, PhD, MD

Organizational Affiliation

Hospital Universitari Mútua Terrassa

Official's Role

Principal Investigator

Facility Information:

Facility Name

Hospital Universitari Mutua Terrassa

City

Terrassa

State/Province

Barcelona

ZIP/Postal Code

08221

Country

Spain

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Pilar Arcusa

Phone

+34 937365050

Ext

11801

parcusa@mutuaterrassa.es

First Name & Middle Initial & Last Name & Degree

Maria Esteve, PhD

First Name & Middle Initial & Last Name & Degree

Albert Martin-Cardona

12. IPD Sharing Statement

Plan to Share IPD

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

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