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Hormone therapy's hidden impact on gut bugs and heart risk revealed in new study.

NCT ID NCT05334888

Knowledge-focused Sponsor: Charite University, Berlin, Germany Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study follows 200 healthy transgender people for five years after they start hormone replacement therapy. Researchers will track changes in gut bacteria, blood markers, and heart risk factors to understand how sex hormones influence the gut-heart connection. The goal is to learn, not to treat or cure any disease.

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 200 people

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

Started

Aug 2022

Expected to finish

Dec 2030

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

Healthy transgender individuals during their gender hormone replacement therapy (HRT)

Ages

18 to 50 years

Sex

Anyone

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: * Age 18-50 * Language requirements: German, English * Previous gender hormone replacement therapy (HRT). * Ability to give consent and written consent to participate. * Health insurance (for clarification of incidental findings) Exclusion Criteria: * Diseases or functional disorders that, in the opinion of the study physician, preclude participation in the study. * Incapacity or other circumstances that do not allow study participants to fully understand the nature, significance and scope of this study.

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Conditions

The condition(s) this trial relates to.

immune system disorder

As listed by the trial registrant

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

Cardiovascular risk factors Gut microbiome Immune system Transgender

How to take part

Only the study team decides who joins. These are the ways to reach them.

  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

  • Experimental and Clinical Research Center, Clinical Research Unit

    RECRUITING

    Berlin, 13125, Germany

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