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

Study Purpose

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.

Recruitment Criteria

Accepts Healthy Volunteers

Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms

 Yes
Study Type

An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.


An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes.


Searching Both is inclusive of interventional and observational studies.

 Interventional
Eligible Ages 18 Years and Over
Gender All
More Inclusion & Exclusion 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.

Trial Details

Trial ID:

This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.

 NCT05084807
Phase

Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans.

Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data.

Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs.

Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.

 N/A
Lead Sponsor

The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.

 Hospital Mutua de Terrassa
Principal Investigator

The person who is responsible for the scientific and technical direction of the entire clinical study.

 Maria Esteve, PhD, MD
Principal Investigator Affiliation Hospital Universitari Mútua Terrassa
Agency Class

Category of organization(s) involved as sponsor (and collaborator) supporting the trial.

 Other
Overall Status Recruiting
Countries Spain
Conditions

The disease, disorder, syndrome, illness, or injury that is being studied.

 Lymphocytic Enteritis (Disorder), Healthy Volunteers
Additional Details

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.

Arms & Interventions

Arms

Other: Healthy group

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

Interventions

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.

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

International Sites

Hospital Universitari Mutua Terrassa, Terrassa, Barcelona, Spain

Status

Recruiting

Address

Hospital Universitari Mutua Terrassa

Terrassa, Barcelona, 08221

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