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Scientists investigate hidden link between Gut-Like bacteria and painful Post-Transplant condition

NCT ID NCT06649201

Knowledge-focused Sponsor: Case Comprehensive Cancer Center 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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Jun 27, 2026 · Last updated Aug 27, 2026 · Updated 2 times

Summary

This observational study follows 40 women undergoing stem cell transplants to track changes in their vaginal microbiome (the collection of bacteria and fungi) and see how it relates to vulvovaginal graft-versus-host disease (GVHD), a painful complication. Participants complete symptom questionnaires and provide vaginal samples before transplant and at 6 and 12 months after. The goal is to learn why some women develop GVHD, not to test a new treatment.

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 40 people

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

Started

Dec 2024

Expected to finish

Feb 2027

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

Female participants undergoing allogenic HCT will be recruited from the Blood and Marrow Transplant Program at the Cleveland Clinic.

Ages

18 to 70 years

Sex

Female participants only

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: * Female participants planning to undergo allogeneic HCT for any disease indication, OR, female participants who have already received HCT and have developed vulvovaginal GVHD during their post-transplant follow-up period * All conditioning regimens (myeloablative or reduced intensity) will be included. * All donor sources (HLA matched/mismatched related, unrelated, umbilical cord, haploidentical) will be included. * All graft sources (bone marrow or peripheral blood stem cells) will be included. * All GVHD prophylaxis regimens will be included. * Aged 18-70. * English speaking and able to sign written informed consent. * Participants agree to a vaginal gynecologic exam. * Co-enrollment on other clinical trials will be allowed. Exclusion Criteria: * Participants who decline or unable to undergo vaginal gynecologic exam due to any discomfort or pain. * Any concurrent medical, psychiatric or other illness in which the provider believes the participants may not be able to comply with study assessments. * Participants with a current diagnosis of a sexually transmitted infection (STI) (Herpes Simplex Virus, Gonorrhea, Chlamydia, Trichomonas,) or a history of previously untreated STI which may incite inflammation that will impact the microbiome. * Participants with a history of lichen sclerosis, lichen planus, pre-transplant. * Participants with a history or current diagnosis of vaginal or vulvar malignancy.

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Conditions

The condition(s) this trial relates to.

graft versus host disease

As listed by the trial registrant

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

Graft VS host disease Vulvovaginal signs and symptoms

How to take part

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  1. The study's own enquiry address

    This study publishes an address for enquiries. See it below .

  2. The places running it

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

  3. 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 ↗

  4. A doctor treating you

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Contacts and locations

Study contacts

  • Contact

    Email: •••••@•••••

Locations

  • Cleveland Clinic Taussig Cancer Institute, Case Comprehensive Cancer Center

    RECRUITING

    Cleveland, Ohio, 44195, United States

    Contact Email: •••••@•••••

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