Gut Microbiota in Patients With Limb Lymphedema and Recurrent Lymphangitis: a Prospective Observational Study (LymphFM)

Institute of Hospitalization and Scientific Care (IRCCS)

Status: Enrolling

Conditions: Lymphedema; Microbiota

Treatments: Other: analysis of a sample of stool

Study type: Observational

Funder types: Other

Identifiers

NCT06228937

6208

Details and patient eligibility

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.

Enrollment: 60 estimated patients

Sex: All

Ages: 18 to 85 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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.

Trial design

60 participants in 2 patient groups

Group A

Description:

patients affected by limb lymphedema with recurrent soft tissue infections

Treatment:

Other: analysis of a sample of stool

Group B

Description:

patients affected by limb lymphedema without recurrent soft tissue infections

Treatment:

Other: analysis of a sample of stool