An observational study in Lymphedema and Microbiota, sponsored by Fondazione Policlinico Universitario Agostino Gemelli IRCCS. Recruiting at 1 site in Italy. Open to participants aged 18 Years to 85 Years. Per ClinicalTrials.gov, last updated 2026-09-03.
Sponsored by Fondazione Policlinico Universitario Agostino Gemelli IRCCS · Observational
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.
529 studies on the registry are indexed under Lymphedema; 131 are open to participants now.
This study's planned enrollment of 60 is below the median of 103 across 145 observational studies indexed under Lymphedema.
Browse Lymphedema studies →Fondazione Policlinico Universitario Agostino Gemelli IRCCS is the lead sponsor of 952 studies on the registry; 541 are open to participants now.
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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).
Inclusion Criteria (Group A):
Inclusion Criteria (Group B):
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
Immunosuppression
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
patients affected by limb lymphedema with recurrent soft tissue infections
Other: analysis of a sample of stool
patients affected by limb lymphedema without recurrent soft tissue infections
Other: analysis of a sample of stool
typing of the gut microbiota from a stool sample
comparison alpha diversity
comparison alpha diversity of the gut microbiota in groups A and B
Time frame: 60 months
comparison beta diversity
comparison beta diversity of the gut microbiota in groups A and B
Time frame: 60 months
evaluation of the microbiome differential abundance
evaluation of the microbiome differential abundance to identify taxa associated
Time frame: 60 months
Plan to share: No
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