Gut Microbiota in Patients With Limb Lymphedema and Recurrent Lymphangitis
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: analysis of a sample of stool.
- Who it may be relevant to
- Registry conditions: Lymphedema, Microbiota. Basic parameters: 18 years — 85 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Italy
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Typing of Gut Microbiota in Patients With Limb Lymphedema and Recurrent Lymphangitis, a Prospective Observational Study
Overview
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.
Interventions
- Other analysis of a sample of stool
typing of the gut microbiota from a stool sample
Primary outcome measures
- comparison alpha diversity [Time frame: 60 months]
Secondary outcome measures (2)
- comparison beta diversity [Time frame: 60 months]
- evaluation of the microbiome differential abundance [Time frame: 60 months]
Eligibility criteria
Inclusion Criteria (Group A):
- 18-85 years
- primary or secondary, upper or lower limb lymphedema, I-II-III stage ISL
- at least 3 episodes of soft tissue infection in an year, in the last 2 years
- consent to participate in the study
Inclusion Criteria (Group B):
- 18-85 years
- primary or secondary, upper or lower limb lymphedema, stage I-II-III (ISL)
- no episodes of soft tissue infection in the last 2 years
- consent to participate in the study
Exclusion criteria
- No compliance to perform limb compression and skin hygiene
- Antibiotic therapy in the last 15 days
- Diabetes mellitus
- Immunodeficiency
- Ongoing neoplastic pathology
- Taking immunosuppressive drugs
- Unavailability to follow-up for at least 24 months post-enrollment.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Cohort
Study locations
Italy · 1 center
- Fondazione Policlinico Universitario Agostino Gemelli IRCCS — Rome
Identifiers
NCT: NCT06228937 · 6208