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Gut Microbiota in Patients With Limb Lymphedema and Recurrent Lymphangitis

ConditionsLymphedemaMicrobiota
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18-85
SponsorFondazione Policlinico Universitario Agostino Gemelli IRCCS

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

No compliance to perform limb compression and skin hygiene

Antibiotic therapy in the last 15 days

Diabetes mellitus

Immunodeficiency

Trial 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).

Trial design

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

  • analysis of a sample of stool

    Other intervention

    typing of the gut microbiota from a stool sample

Treatment groups

60 Participants
are divided into 2 treatment groups
Group A: Group A1 intervention
Group B: Group B1 intervention

Trial outcomes

Primary outcomes

1

comparison alpha diversity

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

Time frame
60 months

Secondary outcomes

1

comparison beta diversity

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

Time frame
60 months
2

evaluation of the microbiome differential abundance

evaluation of the microbiome differential abundance to identify taxa associated

Time frame
60 months

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Fondazione Policlinico Universitario Agostino Gemelli IRCCS

Lead sponsor

Source ClinicalTrials.gov
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