Gut Microbiota in Patients With Limb Lymphedema and Recurrent Lymphangitis (LymphFM)

February 26, 2024 updated by: Fondazione Policlinico Universitario Agostino Gemelli IRCCS

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

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Estimated)

60

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study 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).

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Group A
patients affected by limb lymphedema with recurrent soft tissue infections
Other: analysis of a sample of stool
typing of the gut microbiota from a stool sample
Group B
patients affected by limb lymphedema without recurrent soft tissue infections
Other: analysis of a sample of stool
typing of the gut microbiota from a stool sample

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
comparison alpha diversity
Time Frame: 60 months
comparison alpha diversity of the gut microbiota in groups A and B
60 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
comparison beta diversity
Time Frame: 60 months
comparison beta diversity of the gut microbiota in groups A and B
60 months
evaluation of the microbiome differential abundance
Time Frame: 60 months
evaluation of the microbiome differential abundance to identify taxa associated
60 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Fondazione Policlinico Universitario Agostino Gemelli IRCCS

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

February 22, 2024

Primary Completion (Estimated)

October 30, 2027

Study Completion (Estimated)

October 30, 2028

Study Registration Dates

First Submitted

January 19, 2024

First Submitted That Met QC Criteria

January 19, 2024

First Posted (Actual)

January 29, 2024

Study Record Updates

Last Update Posted (Estimated)

February 28, 2024

Last Update Submitted That Met QC Criteria

February 26, 2024

Last Verified

January 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 6208

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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