Study Results
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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COMPLETED
11 participants
OBSERVATIONAL
2021-01-11
2022-12-22
Brief Summary
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It also seems interesting to make a precise anatomopathological description with a gradation of the digestive fibrotic damage in view of the paucity of medical literature in this field
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Detailed Description
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Conditions
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Study Design
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CASE_CONTROL
PROSPECTIVE
Study Groups
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patients
recruitement of 9 patients
additional biopsies
additional biopsies during a fibroscopy planned in the care
control
recruitement of 9 control person
additional biopsies
additional biopsies during a fibroscopy planned in the care
Interventions
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additional biopsies
additional biopsies during a fibroscopy planned in the care
Eligibility Criteria
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Inclusion Criteria
* Subject under an indication for the performance of esogastro-duodenal fibroscopy (FOGD), the main ones being: anemia, anorexia, weight loss, gastroesophageal reflux disease, dysphagia or odynophagia, ulcer syndrome, suspected portal hypertension
* Supported at Nice University Hospital
* Subject understands and speaks French and is able to give written consent
* Subject affiliated to Social Security or a similar scheme
* Subjects accepting additional digestive biopsies
* Subject aged between 18 and 75 years old, without dysimmunitary disease
* Subject within the scope of an indication for the performance of a FOGD as defined by the treating gastroenterologist
* Subject accepting to be serologically tested for HIV and HCV
* Subject understands and speaks French and is able to give written consent
* Subject affiliated to Social Security or a similar scheme
* Subjects accepting additional digestive biopsies
Exclusion Criteria
* Subject who has participated in a clinical research study in the last 3 months in which he/she was exposed to a pharmaceutical product or medical device
* Subject who has stayed in a tropical or subtropical country in the last 3 months
* Pregnant or breastfeeding participant
* Subject on a special diet for medical reasons and prescribed by a doctor or dietician (e.g. a low-calorie diet or a diet designed to lower cholesterol levels)
* Subject who regularly consumes large quantities of alcohol, i. e. more than 50 g of pure alcohol per day (e. g. more than 4 glasses of 150 ml wine, more than 4 pints of 250 ml beer, or more than 4 glasses of 40 ml containing strong alcohol)
* Subject who has used an illegal recreational drug in the past 3 months
* Subject who has taken an immunosuppressive or immunomodulatory drug (excluding corticosteroids administered at doses ≤ 10 mg/d PREDNISONE equivalent) within the previous 2 weeks, or for more than 14 consecutive days within the last 3 months
* Subject who has been vaccinated within the last 3 months
* Subject who received a blood transfusion or immunoglobulins in the last 3 months
* Subject stating that he has not been fasting for at least 10 hours
* Subject reporting HIV or HCV status
* Subject who had an infectious episode or was treated with antibiotics during the 4 weeks prior to the visit
* Subject with a positive pregnancy test
* Subject with graft versus host disease, or who has received therapy involving hematopoietic stem cells
* Subject with a severe and/or chronic and/or recurrent pathology, in particular:
* A chronic inflammatory disease of the intestine (Crohn's disease, ulcerative colitis), epidermis (psoriasis, atopic dermatitis), joints (rheumatoid arthritis), nervous system (multiple sclerosis); except ScS.
* A neurodegenerative disease
* Diabetes mellitus
* Subject who has been diagnosed with cancer and has not been in remission for more than 5 years
18 Years
75 Years
ALL
No
Sponsors
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Centre Hospitalier Universitaire de Nice
OTHER
Responsible Party
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Locations
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Nice Hospital
Nice, , France
Countries
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Other Identifiers
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19-AOI-07
Identifier Type: -
Identifier Source: org_study_id
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