Gut Microbiota in Patients With Limb Lymphedema and Recurrent Lymphangitis

Lymphedema Clinical Trial

— LymphFM  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06228937
• Other study ID #: 6208
• Status: Recruiting
• Start date: February 22, 2024
• Est. completion date: October 30, 2028

Study information

• Verified date: January 2024
• Source: Fondazione Policlinico Universitario Agostino Gemelli IRCCS
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 60
• Est. completion date: October 30, 2028
• Est. primary completion date: October 30, 2027
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 85 Years

Eligibility

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.

Related Conditions & MeSH terms

• Lymphedema
• Microbiota

Intervention

Other:
• analysis of a sample of stool
typing of the gut microbiota from a stool sample

Locations

Country	Name	City	State
Italy	Fondazione Policlinico Universitario Agostino Gemelli IRCCS	Rome

Sponsors (1)

Lead Sponsor	Collaborator
Fondazione Policlinico Universitario Agostino Gemelli IRCCS

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	comparison alpha diversity	comparison alpha diversity of the gut microbiota in groups A and B	60 months
Secondary	comparison beta diversity	comparison beta diversity of the gut microbiota in groups A and B	60 months
Secondary	evaluation of the microbiome differential abundance	evaluation of the microbiome differential abundance to identify taxa associated	60 months