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

NCT ID: NCT05084807

Last Updated: 2021-10-20

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

20 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-06-01

Study Completion Date

2022-12-31

Brief Summary

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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

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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.

Conditions

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Lymphocytic Enteritis (Disorder) Healthy Volunteers

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

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

BASIC_SCIENCE

Blinding Strategy

NONE

Study Groups

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Healthy group

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

Group Type OTHER

Endoscopy

Intervention Type 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.

Interventions

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Endoscopy

* 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.

Intervention Type OTHER

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Hospital Mutua de Terrassa

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Maria Esteve, PhD, MD

Role: PRINCIPAL_INVESTIGATOR

Hospital Universitari Mútua Terrassa

Locations

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Hospital Universitari Mutua Terrassa

Terrassa, Barcelona, Spain

Site Status RECRUITING

Countries

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Spain

Central Contacts

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Albert Martin-Cardona, MD

Role: CONTACT

[email protected]
+34937365050 ext. 60880

Maria Esteve, PhD, MD

Role: CONTACT

[email protected]
+34937365050 ext. 11210

Facility Contacts

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Pilar Arcusa

Role: primary

[email protected]
+34 937365050 ext. 11801

Other Identifiers

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GUT2020

Identifier Type: -

Identifier Source: org_study_id