Investigating gut microbiota in patients with limb lymphedema and recurrent infections

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This observational study aims to explore the relationship between gut microbiota and limb lymphedema in patients who experience recurrent soft tissue infections. It will analyze stool samples from participants to identify pro-inflammatory changes in their microbiota. The study includes two groups: one with a history of infections and another without, both having lymphedema. By understanding these microbiota changes, the study seeks to shed light on potential underlying mechanisms of infection in lymphedema patients.

Why it matters

Who can join: the full rules

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.

Where it's running

• Fondazione Policlinico Universitario Agostino Gemelli IRCCS
  Rome, Italy Recruiting

Study contacts

• Principal investigator: Stefano Gentileschi — Fondazione Policlinico Universitario Agostino Gemelli IRCCS
• Study coordinator: Stefano Gentileschi
• Email: stefano.gentileschi@policlinicogemelli.it
• Phone: +390630151

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.