Gut Microbiota in Patients With Limb Lymphedema and Recurrent Lymphangitis

Sponsor
Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Study ID
NCT06228937
Status
Recruiting
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Conditions

  • Lymphedema
  • Microbiota

Eligibility Criteria

Sex
ALL
Age
18 Years - 85 Years
Healthy Volunteers
Not accepted

Interventions

  • analysis of a sample of stool — OTHER
    typing of the gut microbiota from a stool sample

Study Details

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.

Key Dates

First listed
Jan 29, 2024
Start date
Feb 22, 2024
Status verified
Jan 2024
Primary completion
Oct 30, 2027
Completion
Oct 30, 2028

Study Design

Enrollment
60 participants (estimated)

Arms

  • Arm: Group A
    patients affected by limb lymphedema with recurrent soft tissue infections
  • Arm: Group B
    patients affected by limb lymphedema without recurrent soft tissue infections

Primary Outcome Measure

comparison alpha diversity [ Time Frame: 60 months ]

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