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NCT Number: NCT06228937

Gut Microbiota in Patients With Limb Lymphedema and Recurrent Lymphangitis

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.

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Key information

Conditions

Lymphedema Hemic and Lymphatic Diseases Lymphatic Diseases Microbiota

Age range

18 year–85 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

analysis of a sample of stool

Other

typing of the gut microbiota from a stool sample

Primary outcomes

  1. comparison alpha diversity

    Time frame: 60 months

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

Secondary outcomes

  1. comparison beta diversity

    Time frame: 60 months

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

  2. evaluation of the microbiome differential abundance

    Time frame: 60 months

    evaluation of the microbiome differential abundance to identify taxa associated

Sponsors and collaborators

Lead sponsor

Fondazione Policlinico Universitario Agostino Gemelli IRCCS

Other

Registry information

Official study title

Typing of Gut Microbiota in Patients With Limb Lymphedema and Recurrent Lymphangitis, a Prospective Observational Study

Acronym: LymphFM

Important dates

Study start
2024
Primary completion
2027
Study completion
2028
First posted
Jan 29, 2024
Registry last updated
Feb 28, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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