Actively Recruiting
Gut Microbiota in Patients With Limb Lymphedema and Recurrent Lymphangitis
Led by Fondazione Policlinico Universitario Agostino Gemelli IRCCS · Updated on 2024-02-28
60
Participants Needed
1
Research Sites
244 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Gut Microbiota in Patients With Limb Lymphedema and Recurrent Lymphangitis
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age between 18 and 85 years
- Primary or secondary lymphedema of the upper or lower limbs, stages I, II, or III according to ISL
- For Group A: at least 3 soft tissue infection episodes per year in the last 2 years
- For Group B: no soft tissue infection episodes in the last 2 years
- Consent to participate in the study
You will not qualify if you...
- Inability or unwillingness to comply with limb compression and skin hygiene requirements
- Antibiotic treatment within the last 15 days
- Diagnosis of diabetes mellitus
- Presence of immunodeficiency
- Ongoing cancer or neoplastic disease
- Use of immunosuppressive drugs
- Unavailability for follow-up for at least 24 months after enrollment
AI-Screening
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Trial Site Locations
Total: 1 location
1
Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Rome, Italy, 00168
Actively Recruiting
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
2
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