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Could gut bacteria predict infection risk in lymphedema?

NCT ID NCT06228937

Knowledge-focused Sponsor: Fondazione Policlinico Universitario Agostino Gemelli IRCCS Source: ClinicalTrials.gov ↗

What the study statuses mean

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Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Sep 03, 2026 · Last updated Sep 04, 2026 · Updated 1 time

Summary

This study compares the gut microbiota of people with lymphedema who have had repeated soft tissue infections to those who have not. Researchers will analyze stool samples from 60 participants to see if certain bacteria are more common in the infection-prone group. The goal is to understand whether gut bacteria might play a role in triggering these infections.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
Stool sample analysis for gut microbiota typing
What this could lead to
If differences in gut bacteria are found, it could point toward new ways to prevent or treat recurrent infections in people with lymphedema.
What could go wrong
This is an observational study, so it can only show associations, not cause and effect. The sample size is small, and results may not apply to all lymphedema patients.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Participants

About 60 people

The number the study aims to enrol. It can still change while the study runs.

Started

Feb 2024

Expected to finish

Oct 2028

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Who is studied

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).

Ages

18 to 85 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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.

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Conditions

The condition(s) this trial relates to.

lymphedema

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Lymphedema Microbiota

How to take part

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  1. The places running it

    1 site. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Fondazione Policlinico Universitario Agostino Gemelli IRCCS

    RECRUITING

    Rome, 00168, Italy

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