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Search / Trial NCT06228937

Gut Microbiota in Patients With Limb Lymphedema and Recurrent Lymphangitis

Launched by FONDAZIONE POLICLINICO UNIVERSITARIO AGOSTINO GEMELLI IRCCS · Jan 19, 2024

Trial Information

Current as of June 30, 2025

Recruiting

Keywords

ClinConnect Summary

This clinical trial is studying the relationship between gut bacteria (the microbiota) and patients who have lymphedema, a condition that causes swelling in the limbs and can lead to repeated infections. Researchers want to find out if changes in gut bacteria can explain why some lymphedema patients experience frequent skin infections, such as cellulitis or lymphangitis. The hope is to better understand how these infections develop in order to improve treatments for those affected.

To participate in this study, you must be between 18 and 85 years old and have lymphedema in either your arms or legs. There are two groups: one group includes patients who have had at least three infections in the last two years, while the other group includes patients who have not had any infections in that time. Participants will need to agree to follow certain health guidelines and attend follow-up appointments for up to two years. This research could provide valuable insights into the link between gut health and lymphedema, potentially leading to better management strategies for those living with this condition.

Gender

ALL

Eligibility 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.

About Fondazione Policlinico Universitario Agostino Gemelli Irccs

Fondazione Policlinico Universitario Agostino Gemelli IRCCS is a leading research and healthcare institution based in Rome, Italy, renowned for its commitment to advancing medical science and improving patient care. As a prominent academic medical center affiliated with the Catholic University of the Sacred Heart, it integrates clinical practice, education, and research, fostering innovation in various fields of medicine. The foundation conducts a wide range of clinical trials aimed at developing new therapies and enhancing treatment protocols, with a focus on translational research that bridges the gap between laboratory discoveries and patient care. Its multidisciplinary approach and dedication to high ethical standards position it as a key player in the landscape of clinical research and healthcare improvement in Italy and beyond.

Locations

Rome, , Italy

Patients applied

0 patients applied

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported