LymphedemaLymphFMNCT06228937
Gut Microbiota in Patients With Limb Lymphedema and Recurrent Lymphangitis
An observational study of Lymphedema and Microbiota, run by Fondazione Policlinico Universitario Agostino Gemelli IRCCS at 1 site in Italy.
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. Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Lymphedema, Microbiota
- What is being tested?
- analysis of a sample of stool
- How many people
- 60 participants
- Where
- 1 siteItaly
- Study dates
- 22 Feb 2024to 30 Oct 2028
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
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).
Who may be able to join
- 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
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Italy1 site, 1 recruiting
- Recruiting
Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Rome, 00168
Stefano Gentileschi, Prof., +390630151, stefano.gentileschi@policlinicogemelli.it
Anna Amelia Caretto, MD, +390630151, annaamelia.caretto@guest.policlinicogemelli.it
About this study
Official title: 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.
- Conditions
- Lymphedema, Microbiota
- Being tested
- analysis of a sample of stool
- Medical subject headings
- Lymphedema
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
analysis of a sample of stoolOther
typing of the gut microbiota from a stool sample
| Study group | Role | What they receive |
|---|---|---|
| Group A | patients affected by limb lymphedema with recurrent soft tissue infections Receives: Other: analysis of a sample of stool | |
| Group B | patients affected by limb lymphedema without recurrent soft tissue infections Receives: Other: analysis of a sample of stool |
What is being measured
The primary outcome is the main question the study is designed to answer.
comparison alpha diversity
comparison alpha diversity of the gut microbiota in groups A and B
Measured: 60 months
Secondary outcomes (2)
comparison beta diversity
comparison beta diversity of the gut microbiota in groups A and B
Measured: 60 months
evaluation of the microbiome differential abundance
evaluation of the microbiome differential abundance to identify taxa associated
Measured: 60 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jan 2024
- Study start22 Feb 2024
- Primary completion30 Oct 2027 (estimated)
- Study completion30 Oct 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for LymphedemaStudies of the same condition, open and under way.
- More trials run by Fondazione Policlinico Universitario Agostino Gemelli IRCCSThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Stefano Gentileschi, Principal investigator, Fondazione Policlinico Universitario Agostino Gemelli IRCCS
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06228937
- Sponsor's protocol ID
- 6208
- Acronym
- LymphFM
- Status last verified
- Sep 2026
- First submitted
- 19 Jan 2024
- Last updated
- 3 Sep 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Typing of Gut Microbiota in Patients With Limb Lymphedema and Recurrent Lymphangitis, a Prospective Observational Study
- ClinicalTrials.gov ID
- NCT06228937
- Acronym / sponsor ID
- LymphFM / 6208
- Conditions
- Lymphedema, Microbiota
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Fondazione Policlinico Universitario Agostino Gemelli IRCCSUniversity, hospital or other
- Study start
- 22 Feb 2024 (actual)
- Primary completion
- 30 Oct 2027 (estimated)
- Study completion
- 30 Oct 2028 (estimated)
- First posted
- 29 Jan 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group A | – | Other: analysis of a sample of stoolpatients affected by limb lymphedema with recurrent soft tissue infections |
| Group B | – | Other: analysis of a sample of stoolpatients affected by limb lymphedema without recurrent soft tissue infections |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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).
Key inclusion criteria (8 listed)
- 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
Key exclusion criteria (7 listed)
- No compliance to perform limb compression and skin hygiene
- Antibiotic therapy in the last 15 days
- Diabetes mellitus
- Immunodeficiency
- Ongoing neoplastic pathology
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| analysis of a sample of stooltyping of the gut microbiota from a stool sample | Other | Group A, Group B |
Primary outcome
comparison alpha diversity
Time frame: 60 months
comparison alpha diversity of the gut microbiota in groups A and B
2 secondary outcomes
comparison beta diversity
Time frame: 60 months
evaluation of the microbiome differential abundance
Time frame: 60 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Sep 2026.
- Individual participant dataSharing planned: No
Related trials for Lymphedema
Not yet recruitingObservational study
Comparison of Reliability, Time Cost, and Participant Comfort of Lymphedema Assessments in Upper Extremity
Lymphedema, Upper Extremity Lymphedema
Enrolling by invitation
Comparison of the Effects of Kinesio Taping and Compression Bandaging on Edema, Range of Motion, Upper Extremity Function, and Grip Strength in Patients With Breast Cancer-Related Lymphedema
Lymphedema, Lymphedema Arm
RecruitingObservational study
A Post-market, Real-world Experience: Expanding Access to Care by Incorporating the Symani® Surgical System and Enabling Surgeons
Open Surgery, Lymphedema
Not yet recruiting
Agentic AI App and Home Bioimpedance Monitoring for Endocrine Therapy Adherence and Lymphedema in Breast Cancer Survivors
Breast Neoplasm Malignant Primary, Lymphedema Arm
Active, not recruiting
The Effectiveness of Lymphatic Bypass Supermicrosurgery
Breast Cancer Related Lymphedema, Lymphedema Arm
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Stefano Gentileschi principal investigator
Fondazione Policlinico Universitario Agostino Gemelli IRCCS
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Lymphedema and Microbiota, run by Fondazione Policlinico Universitario Agostino Gemelli IRCCS at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 3 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Stefano Gentileschi (+390630151, stefano.gentileschi@policlinicogemelli.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
comparison alpha diversity (time frame: 60 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Sep 2026; AzTrials last refreshed its copy on 7 Nov 2026.