Gut Microbiota in Patients With Limb Lymphedema and Recurrent Lymphangitis

Typing of Gut Microbiota in Patients With Limb Lymphedema and Recurrent Lymphangitis, a Prospective Observational Study

Status

Recruiting

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT06228937

Acronym

LymphFM

Enrollment

Registered

2024-01-29

Start date

2024-02-22

Completion date

2028-10-30

Last updated

2026-09-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Lymphedema, Microbiota

Brief 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.

Interventions

OTHERanalysis of a sample of stool

typing of the gut microbiota from a stool sample

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to 85 Years

Healthy volunteers

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.

Design outcomes

Primary

Measure	Time frame	Description
comparison alpha diversity	60 months	comparison alpha diversity of the gut microbiota in groups A and B

Secondary

Measure	Time frame	Description
comparison beta diversity	60 months	comparison beta diversity of the gut microbiota in groups A and B
evaluation of the microbiome differential abundance	60 months	evaluation of the microbiome differential abundance to identify taxa associated

Countries

Italy

Contacts

CONTACTStefano Gentileschi

stefano.gentileschi@policlinicogemelli.it+390630151

PRINCIPAL_INVESTIGATORStefano Gentileschi

Fondazione Policlinico Universitario Agostino Gemelli IRCCS

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Sep 4, 2026