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New treatment option for Advanced Ovarian Carcinoma
Official title Effects of a Probiotic Intervention on the Gut and Vaginal Microbiome in Patients With Advanced or Recurrent Ovarian Cancer Undergoing Treatment With Platinum Chemotherapy
ClinicalTrials.gov ID: NCT07144826
What this study is testing
- What it's testing
- This clinical trial evaluates the effects a probiotic intervention has on the gut and vaginal microbiome in patients undergoing chemotherapy for ovarian cancer that may have spread from where it first started to nearby tissue, lymph nodes, or distant parts of the body (advanced) or that has come back after a period of improvement (recurrent). Gut health is also known as the gut microbiome.
- Phase 1: an early, usually small safety study
- You might receive a placebo (an inactive treatment) instead of the study drug, decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older, women only
You may be able to join if
- Ability to understand and willingness to sign a written consent form. In patients who do not speak English, ability to have informed consent form...
- Age \> 18 years old
- Patient with advanced (stage II, III or IV) or recurrent ovarian cancer who will receive platinum-based chemotherapy as standard of care (cisplatin...
- Agreeable to participate in all research activities defined in the study
- Agreeable to not take any other probiotic and/or prebiotic supplements outside of study intervention during the study
You likely can't join if
- Borderline ovarian tumors
- Prior allergy or food intolerance to any probiotic product
- History of chronic inflammation or active structural abnormality of the digestive tract (e.g., inflammatory bowel disease requiring medications...
- Patients who do not meet laboratory parameters for platinum-based chemotherapy, including absolute neutrophil count (ANC) \< 1500
- Known hypersensitivity to any component of study product (Akkermansia muciniphila, Anaerobutyricum hallii, Clostridium beijerinckii, Clostridium...
- Known hypersensitivity to \> 4 first-line antimicrobial therapies against Akkermansia muciniphila, Clostridium beijerinckii, Clostridium butyricum...
See the full eligibility criteria
- Ability to understand and willingness to sign a written consent form. In patients who do not speak English, ability to have informed consent form translated in their native language and have their native language...
- Age \> 18 years old
- Patient with advanced (stage II, III or IV) or recurrent ovarian cancer who will receive platinum-based chemotherapy as standard of care (cisplatin, carboplatin containing regimens)
- Agreeable to participate in all research activities defined in the study
- Agreeable to not take any other probiotic and/or prebiotic supplements outside of study intervention during the study
- Agreeable to not make significant changes to their diet throughout the course of the study
- Patients with ileostomy, colostomy are permitted to participate
- Borderline ovarian tumors
- Prior allergy or food intolerance to any probiotic product
- History of chronic inflammation or active structural abnormality of the digestive tract (e.g., inflammatory bowel disease requiring medications, active duodenal or gastric ulcer, complete large or small bowel intestinal...
- Patients who do not meet laboratory parameters for platinum-based chemotherapy, including absolute neutrophil count (ANC) \< 1500
- Known hypersensitivity to any component of study product (Akkermansia muciniphila, Anaerobutyricum hallii, Clostridium beijerinckii, Clostridium butyricum and Bifidobacterium infantis, chicory inulin, magnesium...
- Known hypersensitivity to \> 4 first-line antimicrobial therapies against Akkermansia muciniphila, Clostridium beijerinckii, Clostridium butyricum, Anaerobutyricum hallii: penicillin, piperacillin, tetracycline...
- Known hypersensitivity to \> 4 first-line antimicrobial therapies against Bifidobacterium infantis Bi-26\^Trademark (TM): gentamicin, kanamycin, streptomycin, tetracycline, erythromycin, clindamycin, ampicillin...
The study team makes the final eligibility decision.
Where it's taking place
- Columbus, Ohio, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling female, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Columbus, Ohio, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.