Gut Microbiota in Patients With Limb Lymphedema and Recurrent Lymphangitis

NCT06228937 | Recruiting

• 1 other identifier: 6208
• Study Type: observational
• Target: 60
• Locations: 1 country
• Sites: 1

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.

Conditions

Lymphedema; Microbiota

Outcome Measures

Primary Outcomes (1)

• comparison alpha diversity

  comparison alpha diversity of the gut microbiota in groups A and B

  60 months

Secondary Outcomes (2)

• comparison beta diversity

  60 months

• evaluation of the microbiome differential abundance

  60 months

Study Arms (2)

Group A

patients affected by limb lymphedema with recurrent soft tissue infections

Other: analysis of a sample of stool

Group B

patients affected by limb lymphedema without recurrent soft tissue infections

Other: analysis of a sample of stool

Interventions

analysis of a sample of stool OTHER

typing of the gut microbiota from a stool sample

Group A; Group B

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

A prospective observational cohort study will be conducted on patients with limb lymphedema, clinical stage I, II and III according to the International Society of Lymphology (ISL), followed by the Plastic Surgery Unit of the University Polyclinic A. Gemelli IRCCS. According to the positive or negative history for recurrent soft tissue infectious episodes, patients will be divided into two homogeneous groups for demographic and clinical characteristics (Groups A and B).

You may qualify if:

• 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
• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Fondazione Policlinico Universitario Agostino Gemelli IRCCS: lead

Study Sites (1)

Fondazione Policlinico Universitario Agostino Gemelli IRCCS

Rome, 00168, Italy

RECRUITING

MeSH Terms

Conditions

Lymphedema

Condition Hierarchy (Ancestors)

Lymphatic Diseases; Hemic and Lymphatic Diseases

Study Officials

• Stefano Gentileschi

  Fondazione Policlinico Universitario Agostino Gemelli IRCCS

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Stefano Gentileschi

CONTACT

+390630151; stefano.gentileschi@policlinicogemelli.it

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 19, 2024
• First Posted: January 29, 2024
• Study Start: February 22, 2024
• Primary Completion (Estimated): October 30, 2027
• Study Completion (Estimated): October 30, 2028
• Last Updated: September 3, 2026

Record last verified: 2026-09

Data Sharing

• IPD Sharing: Will not share

Locations

IT (1)