NCT05084807

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

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 20 (estimated)
• Sponsor: Hospital Mutua de Terrassa · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

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.

Conditions

• Lymphocytic Enteritis (Disorder)
• Healthy Volunteers

Interventions

Type	Name	Description
OTHER	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.

Timeline

• Start date: 2021-06-01
• Primary completion: 2022-06-01
• Completion: 2022-12-31
• First posted: 2021-10-20
• Last updated: 2021-10-20

Locations

1 site across 1 country: Spain