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Vaginal Microbiome and the Development of Vulvovaginal Graft Versus Host Disease

Vaginal Microbiome and the Risk of Vulvovaginal Graft Versus Host Disease Following Hematopoietic Stem Cell Transplantation

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT05316740
Enrollment
40
Registered
2022-04-07
Start date
2022-02-15
Completion date
2026-12-31
Last updated
2025-03-20

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Bone Marrow Transplant Complications

Brief summary

Allogeneic stem cell transplantation (also termed bone marrow transplantation) involves transferring stem cells from a healthy person (the donor) to the patient, after high-intensity chemotherapy or radiation, given to destroy any remaining cancer cells in the body. When a transplant is successful, the donor stem cells replace the original cells in the bone marrow. It may provide the only long-term cure of the patient's disease. Of transplant-related complications, graft-versus-host disease (GVHD) is one of the most important complications. GVHD arises from donor immune cells, that identify the recipient's (the patien's) cells as foreign and attack them. Approximately half of women undergoing transplantation will experience GVHD involving the genitalia (i.e., the vulva and vagina), termed vulvovaginal GVHD (VV-GVHD). VV-GVHD may cause irreversible anatomical changes, including complete vaginal obliteration, and not surprisingly, it has a severe impact on patients' quality of life and sexual function. This complication is unpredictable and non-preventable by the usual immunosuppressive treatment given to patients. Frequent gynecological examinations and prolonged follow-up of transplanted women are needed, to allow early diagnosis and prevention of harmful results of VV-GVHD. This follow-up adds inconvenience and anxiety to the patients. The suggested study aims to evaluate a possible association between vaginal microorganisms (the microbiome) to the progress of VV-GVHD. Finding such association may allow prediction of VV-GVHD progress, a better understanding of the development of VV-GVHD and a potential to develop interventions for the treatment and prevention of VV-GVHD.

Interventions

OTHERNo intervention

Repeated clinical evaluation and sample collection

Sponsors

Rambam Health Care Campus
CollaboratorOTHER
Tel-Aviv Sourasky Medical Center
CollaboratorOTHER_GOV
Hadassah Medical Organization
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

* Age≥18 * Candidate for allogeneic stem cell transplantation * Ability to sign an informed consent

Exclusion criteria

\- Patient does not approve sample collection

Design outcomes

Primary

MeasureTime frameDescription
Microbiome composition2 yearsCharacterization of the vaginal microbial community using shotgun analysis and16S rRNA sequencing
CMV presence2 yearsEvaluation of CMV in vaginal samples using PCR assay
Vulvovaginal graft vs host disease presence2 yearsEvaluation of presence of vulvovaginal GVHD by gynecologic examination, using the NIH classification system for chronic graft-versus-host disease

Secondary

MeasureTime frameDescription
HPV presence2 yearsEvaluation of HPV in vaginal samples

Countries

Israel

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026