Gut Microbiota in Patients With Limb Lymphedema and Recurrent Lymphangitis

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

60 participants

Study Classification

OBSERVATIONAL

Study Start Date

2024-02-22

Study Completion Date

2028-10-30

Brief Summary

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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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Detailed Description

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Conditions

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Lymphedema Microbiota

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Group A

patients affected by limb lymphedema with recurrent soft tissue infections

analysis of a sample of stool

Intervention Type OTHER

typing of the gut microbiota from a stool sample

Group B

patients affected by limb lymphedema without recurrent soft tissue infections

analysis of a sample of stool

Intervention Type OTHER

typing of the gut microbiota from a stool sample

Interventions

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analysis of a sample of stool

typing of the gut microbiota from a stool sample

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* 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

* 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.

Minimum Eligible Age

18 Years

Maximum Eligible Age

85 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No