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Clinical Trials in Italy / NCT06228937
Recruiting Observational

Gut Microbiota in Patients With Limb Lymphedema and Recurrent Lymphangitis

NCT06228937 · tracked via the Priya Life Science Italy tracker
Sponsor
Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Phase
Observational
Started
2024-02-22
Last updated
2026-09-03

Condition(s) studied

LymphedemaMicrobiota

Investigational drug(s) / intervention(s)

analysis of a sample of stool

analysis of a sample of stool: typing of the gut microbiota from a stool sample

Study summary

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.

Eligibility

Sex
ALL
Min age
18 Years
Max age
85 Years
Healthy volunteers
No
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.

Primary outcome measure(s)

  • comparison alpha diversity — 60 months
    comparison alpha diversity of the gut microbiota in groups A and B

Trial sites (1)

FacilityCityRegionStatus
Fondazione Policlinico Universitario Agostino Gemelli IRCCS Rome Italy Recruiting

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06228937 on ClinicalTrials.gov ↗ ← All trials in Italy