Gut Microbiome and Treatment for Gynecological Cancer Patients Receiving Immunotherapy

Launched by VIOME · Jun 30, 2021

Keywords

ClinConnect Summary

This clinical trial is studying how the gut microbiome— the community of bacteria in our digestive system—affects the treatment of women with advanced or recurrent gynecological cancer who are receiving immunotherapy. The goal is to see if the health of the gut microbiome can influence how well these patients respond to their cancer treatment.

To participate, women over 18 years old who have been diagnosed with advanced or recurrent gynecological cancer and are set to receive immunotherapy can enroll in the study. Participants will provide various samples, including stool, blood, and swabs from the vagina and mouth, and they will also receive dietary recommendations. It's important to note that participants should be able to provide stool samples at three different times and should not be taking certain medications that could affect their gut bacteria, like antibiotics or proton pump inhibitors. This study is currently recruiting, and participants will help researchers learn more about the connection between gut health and cancer treatment.

Gender

FEMALE

Eligibility criteria

• Inclusion Criteria:
• • Adult females \> 18 years old
• • Advanced or recurrent gynecological cancer patients from AHMG Advent Health Orlando Gynecologic Oncology Group
• • Patients for whom an immunotherapy regimen has been ordered
• Exclusion Criteria:
• • Patients unable to provide fecal specimens at three time points
• • Patients unable to read or understand informed consent
• * Taking medications that may affect gut microbiome:
• • Proton pump inhibitors (PPIs)
• • Metformin
• • Antibiotics
• • Laxatives
• • Patients who are receiving investigational agent