Gut Microbiota in Patients With Limb Lymphedema and Recurrent Lymphangitis

Recruiting

• Conditions: Lymphedema; Microbiota
• Interventions: Other: analysis of a sample of stool

• Registration Number: NCT06228937
• Lead Sponsor: Fondazione Policlinico Universitario Agostino Gemelli IRCCS

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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2024-01
• Study First Submitted: 2024-01-19
• Study First Submitted QC: 2024-01-19
• Study First Posted: 2024-01-29
• Study Start: 2024-02-22
• Last Update Submitted: 2024-02-26
• Last Update Posted: 2024-02-28
• Primary Completion: 2027-10-30
• Study Completion: 2028-10-30

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 60

Inclusion Criteria

Not provided

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Group A	analysis of a sample of stool	patients affected by limb lymphedema with recurrent soft tissue infections
Group B	analysis of a sample of stool	patients affected by limb lymphedema without recurrent soft tissue infections

Primary Outcome Measures

Name	Time	Method
comparison alpha diversity	60 months	comparison alpha diversity of the gut microbiota in groups A and B

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Fondazione Policlinico Universitario Agostino Gemelli IRCCS; 🇮🇹 Rome, Italy