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Lymphedema is a chronic and progressive disease of the lymphatic vessels which affects about 300 million people worldwide. Patients may experience recurrent soft tissue infection of the limb affected by lymphedema, in terms of erysipelas, lymphangitis or cellulitis. No previous study has ever investigated the possible role of the gut microbiota in the genesis of acute infectious/inflammatory episodes in these patients. Our hypothesis is that lymphedema patients with recurrent soft tissue infections are characterized by pro-inflammatory changes in the microbiota.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Group A | patients affected by limb lymphedema with recurrent soft tissue infections |
| |
| Group B | patients affected by limb lymphedema without recurrent soft tissue infections |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| analysis of a sample of stool | Other | typing of the gut microbiota from a stool sample |
|
| Measure | Description | Time Frame |
|---|---|---|
| comparison alpha diversity | comparison alpha diversity of the gut microbiota in groups A and B | 60 months |
| Measure | Description | Time Frame |
|---|---|---|
| comparison beta diversity | comparison beta diversity of the gut microbiota in groups A and B | 60 months |
| evaluation of the microbiome differential abundance | evaluation of the microbiome differential abundance to identify taxa associated |
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Inclusion Criteria (Group A):
Inclusion Criteria (Group B):
Exclusion Criteria:
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A prospective observational cohort study will be conducted on patients with limb lymphedema, clinical stage I, II and III according to the International Society of Lymphology (ISL), followed by the Plastic Surgery Unit of the University Polyclinic A. Gemelli IRCCS. According to the positive or negative history for recurrent soft tissue infectious episodes, patients will be divided into two homogeneous groups for demographic and clinical characteristics (Groups A and B).
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Fondazione Policlinico Universitario Agostino Gemelli IRCCS | Recruiting | Rome | 00168 | Italy |
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| ID | Term |
|---|---|
| D008209 | Lymphedema |
| ID | Term |
|---|---|
| D008206 | Lymphatic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
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| 60 months |