Investigating gut microbiota in patients with limb lymphedema and recurrent infections
Typing of Gut Microbiota in Patients With Limb Lymphedema and Recurrent Lymphangitis, a Prospective Observational Study
This study looks at how the bacteria in the gut might be linked to limb lymphedema and repeated infections in patients to see if there are any important differences between those who have infections and those who don’t.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 60 (estimated) |
| Ages | 18 Years to 85 Years |
| Sex | All |
| Sponsor | Fondazione Policlinico Universitario Agostino Gemelli IRCCS Academic / other |
| Locations | 1 site (Rome) |
| Trial ID | NCT06228937 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18-85 with upper or lower limb lymphedema and a history of recurrent soft tissue infections.
Not a fit: Patients with conditions such as diabetes, immunodeficiency, or those currently on antibiotic therapy may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to new insights into managing recurrent infections in lymphedema patients, potentially improving their quality of life.
How similar studies have performed: While this approach is novel in the context of lymphedema, similar studies have shown promising results in understanding microbiota's role in other inflammatory conditions.
Eligibility criteria
Show full inclusion / 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.
Where this trial is running
Rome
- Fondazione Policlinico Universitario Agostino Gemelli IRCCS — Rome, Italy (Recruiting)
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.