Advanced Ovarian CarcinomaEarly Phase 1NCT07144826
Effects of a Probiotic Intervention on the Gut and Vaginal Microbiome in Patients With Advanced or Recurrent Ovarian Cancer Undergoing Treatment With Platinum Chemotherapy
A Early Phase 1 study testing Biospecimen Collection, Probiotic and Questionnaire Administration in people with Advanced Ovarian Carcinoma and Recurrent Ovarian Carcinoma, run by Ohio State University Comprehensive Cancer Center at 1 site in United States.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Advanced Ovarian Carcinoma, Recurrent Ovarian Carcinoma, Stage II Ovarian Cancer AJCC v8
- What is being tested?
- Biospecimen Collection, Probiotic and Questionnaire Administration
- Type of treatment
- Pill or oral medicine, Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 161 participants
- Where
- 1 siteUnited States
- Study dates
- 6 Mar 2026to 9 Jul 2027
- Phase
- Early Phase 1
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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 translator present for consenting process
- 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
Who cannot join
- 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 obstruction, active fistula)
- 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 stearate, grape food color, and silica)
- Known hypersensitivity to > 4 first-line antimicrobial therapies against Akkermansia muciniphila, Clostridium beijerinckii, Clostridium butyricum, Anaerobutyricum hallii: penicillin, piperacillin, tetracycline, amoxicillin, ampicillin
- Known hypersensitivity to > 4 first-line antimicrobial therapies against Bifidobacterium infantis Bi-26^Trademark (TM): gentamicin, kanamycin, streptomycin, tetracycline, erythromycin, clindamycin, ampicillin, vancomycin
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
The Ohio State University Comprehensive Cancer Center contact
United States1 site, 1 recruiting
- Recruiting
Ohio State University Comprehensive Cancer Center
Columbus, Ohio, 43210
Laura Chambers, DO, 614-293-7642, laura.chambers@osumc.edu
Laura Chambers, DO
About this study
Official title: A Randomized, Double-Blind, Placebo Controlled, Study to Investigate Efficacy of a Probiotic Intervention on the Gut and Vaginal Microbiome of Ovarian Cancer Patients Undergoing Treatment With Platinum Chemotherapy
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. The microbiome includes all of the bacteria and organisms naturally found in the digestive tract. Probiotics are dietary supplements containing live microorganisms that may help keep the gastrointestinal tract healthy. A probiotic intervention during platinum chemotherapy in ovarian cancer patients may impact the gut and vaginal microbiota, quality of life, symptoms, and oncologic outcomes.
Read the detailed description
PRIMARY OBJECTIVE:
- To evaluate changes to the gut microbiome composition in ovarian cancer patients randomized to a probiotic intervention versus placebo during platinum chemotherapy.
SECONDARY OBJECTIVES:
- Compliance with probiotic intervention in ovarian cancer patients during chemotherapy.
II. Compliance with gut microbiome collection in ovarian cancer patients during chemotherapy.
III. Compliance with vaginal microbiome collection in ovarian cancer patients during chemotherapy.
IV. Recurrence free survival (RFS). V. Overall survival (OS).
EXPLORATORY OBJECTIVES:
- To evaluate changes in the vaginal microbiome composition of ovarian cancer patients randomized to a probiotic intervention versus placebo during platinum chemotherapy.
II. Assess pre-chemotherapy diet according to the Food Frequency Questionnaire (FFQ, Diet History Questionnaire [DHQ3]) questionnaire and how this influences the patient's baseline gut and vaginal microbiome.
III. Assess whether a probiotic intervention influences chemotherapy toxicity and morbidity.
IV. Assess whether a probiotic intervention influences stool consistency or need for additional medications during chemotherapy.
- Assess impact of gut and vaginal microbiome on patient quality of life. VI. Assess changes in serum metabolomic and immune markers as a result of the probiotic intervention.
VII. Assess whether probiotic intervention is associated with chemotherapy-induced neutropenia, neutropenic fever and dose-delays.
VIII. In patients who undergo standard-of-care surgery during chemotherapy, assessment of post-operative infectious outcomes, including surgical site infection in ovarian cancer patients randomized to a probiotic intervention versus placebo during platinum chemotherapy.
IX. In patients who undergo standard-of-care surgery during chemotherapy, assessment of the tumor microbiome as a result of probiotic intervention versus placebo.
- In patients who are treated with antibiotics as standard of care for infectious causes during chemotherapy, assess changes in the vaginal and gut microbiome related to antibiotic therapy.
OUTLINE: Patients are randomized to 1 of 2 arms.
ARM I: Patients receive probiotic orally (PO) twice daily (BID) beginning within seven days of standard of care (SOC) platinum chemotherapy cycle 1 until seven days after their cycle 6. Cycles repeat every 21 days for up to 6 cycles in the absence of disease progression or unacceptable toxicity. Patients also undergo blood and vaginal sample collection throughout the study.
ARM II: Patients receive placebo PO BID beginning within seven days of SOC platinum chemotherapy cycle 1 until seven days after their cycle 6. Cycles repeat every 21 days for up to 6 cycles in the absence of disease progression or unacceptable toxicity. Patients also undergo blood and vaginal sample collection throughout the study.
- Conditions
- Advanced Ovarian Carcinoma, Recurrent Ovarian Carcinoma, Stage II Ovarian Cancer AJCC v8, Stage III Ovarian Cancer AJCC v8, Stage IV Ovarian Cancer AJCC v8
- Being tested
- Biospecimen Collection, Placebo Administration, Probiotic, Questionnaire Administration
- Medical subject headings
- Ovarian Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Biospecimen CollectionProcedure or surgery
Also called Biological Sample Collection, Biospecimen Collected, Specimen Collection
Undergo blood and vaginal sample collection
Placebo AdministrationDrug
Given PO
ProbioticDietary supplement
Also called Probiotic Supplement, Probiotic supplements (pills, liquid, powder; or other probiotics)
Given PO
Questionnaire AdministrationOther
Ancillary studies
| Study group | Role | What they receive |
|---|---|---|
| Arm I (probiotic) | Experimental | Patients receive probiotic PO BID beginning within seven days of SOC platinum chemotherapy cycle 1 until seven days after their cycle 6. Cycles repeat every 21 days for up to 6 cycles in the absence of disease progression or unacceptable toxicity. Patients also undergo blood and vaginal sample collection throughout the study. Receives: Procedure: Biospecimen Collection; Dietary Supplement: Probiotic; Other: Questionnaire Administration |
| Arm II (placebo) | Placebo comparator | Patients receive placebo PO BID beginning within seven days of SOC platinum chemotherapy cycle 1 until seven days after their cycle 6. Cycles repeat every 21 days for up to 6 cycles in the absence of disease progression or unacceptable toxicity. Patients also undergo blood and vaginal sample collection throughout the study. Receives: Procedure: Biospecimen Collection; Drug: Placebo Administration; Other: Questionnaire Administration |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes to the gut microbiome composition
Will be assessed by stool samples collected from all patients. Microbe diversity and communities are assessed by 16s ribosomal ribonucleic acid sequencing and metagenomic whole-genome shotgun sequencing. Presence of microbes between responders and non-responders will be compared using Fisher's exact tests and logistic regression. Changes over time will be assessed using generalized linear or logistic regression models accounting for repeated measures, depending on the format of the outcome variable.
Measured: Within one week before or after cycle 1 of chemotherapy, within one week before or after cycle 3 of adjuvant chemotherapy, and within one week before or after cycle 6 of adjuvant chemotherapy (cycle length = 21 days)
Secondary outcomes (5)
Patient compliance with taking probiotic pills
Will be assessed by patient compliance with taking probiotic pills based on the number of pills dispensed versus number of pills remaining at visits, and reason for non-compliance. Compliance will be assessed with patient completion of surveys and return of kits by determining % of kits returned compared to those given to patients and assessing the period of time between when a microbiome kit was provided to a patient and when they returned it. All analyses will be done using SAS (version 9.4, The SAS Institute, Cary, North Carolina [NC]), and a p < 0.05 will be considered statistically significant.
Measured: At chemotherapy visits for cycle 2, 3, 4, 5, and 6 (cycle length = 21 days)
Patient compliance with gut microbiome collection
Will be assessed through number of stool sample kits returned to processing lab versus number of kits given out. Compliance will be assessed with patient completion of surveys and return of kits by determining % of kits returned compared to those given to patients and assessing the period of time between when a microbiome kit was provided to a patient and when they returned it. All analyses will be done using SAS (version 9.4, The SAS Institute, Cary, NC), and a p < 0.05 will be considered statistically significant.
Measured: Within one week before or after cycle 1 of chemotherapy, within one week before or after cycle 3 of adjuvant chemotherapy and within one week before or after cycle 6 of adjuvant chemotherapy (cycle length = 21 days)
Patient compliance with vaginal microbiome collection
Will be assessed through number of vaginal microbiome swab sample kits returned to processing lab versus number of kits given out. Compliance will be assessed with patient completion of surveys and return of kits by determining % of kits returned compared to those given to patients and assessing the period of time between when a microbiome kit was provided to a patient and when they returned it. All analyses will be done using SAS (version 9.4, The SAS Institute, Cary, NC), and a p < 0.05 will be considered statistically significant.
Measured: Within one week before or after cycle 1 of chemotherapy, within one week before or after cycle 3 of adjuvant chemotherapy and within one week before or after cycle 6 of adjuvant chemotherapy (cycle length = 21 days)
Recurrence free survival (RFS)
Kaplan Meier plots will be created to compare the RFS of patients treated with probiotic versus (vs.) placebo, and RFS will also be assessed based on the presence of specific gut microbes, with median RFS being reported, with 95% confidence intervals.
Measured: Months from first cycle of chemotherapy (cycle 1) to time of recurrence defined by primary physician assessment (cycle length = 21 days)
Overall survival (OS)
Kaplan Meier plots will be created to compare the OS of patients treated with probiotic vs. placebo, and OS will also be assessed based on the presence of specific gut microbes, with median OS times being reported, with 95% confidence intervals.
Measured: Months from first cycle of chemotherapy (cycle 1) to time of death (cycle length = 21 days)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Aug 2025
- Study start6 Mar 2026
- Primary completion9 Jul 2027 (estimated)
- Study completion9 Jul 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Advanced Ovarian CarcinomaStudies of the same condition, open and under way.
- More trials run by Ohio State University Comprehensive Cancer CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Early Phase 1
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 161 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Collaborators
- Doris Duke Charitable Foundation, Ovarian Cancer Research Alliance, United States Department of Defense
- Responsible party
- Principal investigator, Laura Chambers, Ohio State University Comprehensive Cancer Center
- Investigators
- Laura Chambers, DO, Principal investigator, Ohio State University Comprehensive Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07144826
- Sponsor's protocol ID
- OSU-24095
- Other IDs
- NCI-2025-05052
- Status last verified
- Aug 2026
- First submitted
- 20 Aug 2025
- Last updated
- 17 Aug 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Double-Blind, Placebo Controlled, Study to Investigate Efficacy of a Probiotic Intervention on the Gut and Vaginal Microbiome of Ovarian Cancer Patients Undergoing Treatment With Platinum Chemotherapy
- ClinicalTrials.gov ID
- NCT07144826
- Acronym / sponsor ID
- OSU-24095
- Conditions
- Advanced Ovarian Carcinoma, Recurrent Ovarian Carcinoma, Stage II Ovarian Cancer AJCC v8, Stage III Ovarian Cancer AJCC v8, Stage IV Ovarian Cancer AJCC v8
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 161 participants (estimated)
- Lead sponsor
- Ohio State University Comprehensive Cancer CenterUniversity, hospital or other
- Collaborators
- Doris Duke Charitable Foundation, Ovarian Cancer Research Alliance, United States Department of Defense
- Study start
- 6 Mar 2026 (actual)
- Primary completion
- 9 Jul 2027 (estimated)
- Study completion
- 9 Jul 2027 (estimated)
- First posted
- 28 Aug 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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. The microbiome includes all of the bacteria and organisms naturally found in the digestive tract. Probiotics are dietary supplements containing live microorganisms that may help keep the gastrointestinal tract healthy. A probiotic intervention during platinum chemotherapy in ovarian cancer patients may impact the gut and vaginal microbiota, quality of life, symptoms, and oncologic outcomes.
Detailed description
PRIMARY OBJECTIVE:
- To evaluate changes to the gut microbiome composition in ovarian cancer patients randomized to a probiotic intervention versus placebo during platinum chemotherapy.
SECONDARY OBJECTIVES:
- Compliance with probiotic intervention in ovarian cancer patients during chemotherapy.
II. Compliance with gut microbiome collection in ovarian cancer patients during chemotherapy.
III. Compliance with vaginal microbiome collection in ovarian cancer patients during chemotherapy.
IV. Recurrence free survival (RFS). V. Overall survival (OS).
EXPLORATORY OBJECTIVES:
- To evaluate changes in the vaginal microbiome composition of ovarian cancer patients randomized to a probiotic intervention versus placebo during platinum chemotherapy.
II. Assess pre-chemotherapy diet according to the Food Frequency Questionnaire (FFQ, Diet History Questionnaire [DHQ3]) questionnaire and how this influences the patient's baseline gut and vaginal microbiome.
III. Assess whether a probiotic intervention influences chemotherapy toxicity and morbidity.
IV. Assess whether a probiotic intervention influences stool consistency or need for additional medications during chemotherapy.
- Assess impact of gut and vaginal microbiome on patient quality of life. VI. Assess changes in serum metabolomic and immune markers as a result of the probiotic intervention.
VII. Assess whether probiotic intervention is associated with chemotherapy-induced neutropenia, neutropenic fever and dose-delays.
VIII. In patients who undergo standard-of-care surgery during chemotherapy, assessment of post-operative infectious outcomes, including surgical site infection in ovarian cancer patients randomized to a probiotic intervention versus placebo during platinum chemotherapy.
IX. In patients who undergo standard-of-care surgery during chemotherapy, assessment of the tumor microbiome as a result of probiotic intervention versus placebo.
- In patients who are treated with antibiotics as standard of care for infectious causes during chemotherapy, assess changes in the vaginal and gut microbiome related to antibiotic therapy.
OUTLINE: Patients are randomized to 1 of 2 arms.
ARM I: Patients receive probiotic orally (PO) twice daily (BID) beginning within seven days of standard of care (SOC) platinum chemotherapy cycle 1 until seven days after their cycle 6. Cycles repeat every 21 days for up to 6 cycles in the absence of disease progression or unacceptable toxicity. Patients also undergo blood and vaginal sample collection throughout the study.
ARM II: Patients receive placebo PO BID beginning within seven days of SOC platinum chemotherapy cycle 1 until seven days after their cycle 6. Cycles repeat every 21 days for up to 6 cycles in the absence of disease progression or unacceptable toxicity. Patients also undergo blood and vaginal sample collection throughout the study.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Arm I (probiotic) | Experimental | Procedure: Biospecimen Collection, Dietary Supplement: Probiotic, Other: Questionnaire AdministrationPatients receive probiotic PO BID beginning within seven days of SOC platinum chemotherapy cycle 1 until seven days after their cycle 6. Cycles repeat every 21 days for up to 6 cycles in the absence of disease progression or unacceptable toxicity. Patients also undergo blood and vaginal sample collection throughout the study. |
| Arm II (placebo) | Placebo comparator | Procedure: Biospecimen Collection, Drug: Placebo Administration, Other: Questionnaire AdministrationPatients receive placebo PO BID beginning within seven days of SOC platinum chemotherapy cycle 1 until seven days after their cycle 6. Cycles repeat every 21 days for up to 6 cycles in the absence of disease progression or unacceptable toxicity. Patients also undergo blood and vaginal sample collection throughout the study. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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 translator present for consenting process
- 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
Key exclusion criteria (7 listed)
- 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 obstruction, active fistula)
- 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 stearate, grape food color, and silica)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Biospecimen CollectionAlso: Biological Sample Collection, Biospecimen Collected, Specimen CollectionUndergo blood and vaginal sample collection | Procedure or surgery | Arm I (probiotic), Arm II (placebo) |
| Placebo AdministrationGiven PO | Drug | Arm II (placebo) |
| ProbioticAlso: Probiotic Supplement, Probiotic supplements (pills, liquid, powder; or other probiotics)Given PO | Dietary supplement | Arm I (probiotic) |
| Questionnaire AdministrationAncillary studies | Other | Arm I (probiotic), Arm II (placebo) |
Primary outcome
Changes to the gut microbiome composition
Time frame: Within one week before or after cycle 1 of chemotherapy, within one week before or after cycle 3 of adjuvant chemotherapy, and within one week before or after cycle 6 of adjuvant chemotherapy (cycle length = 21 days)
Will be assessed by stool samples collected from all patients. Microbe diversity and communities are assessed by 16s ribosomal ribonucleic acid sequencing and metagenomic whole-genome shotgun sequencing. Presence of microbes between responders and non-responders will be compared using Fisher's exact tests and logistic regression. Changes over time will be assessed using generalized linear or logistic regression models accounting for repeated measures, depending on the format of the outcome variable.
5 secondary outcomes
Patient compliance with taking probiotic pills
Time frame: At chemotherapy visits for cycle 2, 3, 4, 5, and 6 (cycle length = 21 days)
Patient compliance with gut microbiome collection
Time frame: Within one week before or after cycle 1 of chemotherapy, within one week before or after cycle 3 of adjuvant chemotherapy and within one week before or after cycle 6 of adjuvant chemotherapy (cycle length = 21 days)
Patient compliance with vaginal microbiome collection
Time frame: Within one week before or after cycle 1 of chemotherapy, within one week before or after cycle 3 of adjuvant chemotherapy and within one week before or after cycle 6 of adjuvant chemotherapy (cycle length = 21 days)
Recurrence free survival (RFS)
Time frame: Months from first cycle of chemotherapy (cycle 1) to time of recurrence defined by primary physician assessment (cycle length = 21 days)
Overall survival (OS)
Time frame: Months from first cycle of chemotherapy (cycle 1) to time of death (cycle length = 21 days)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Aug 2026.
- The JameslineLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
The Ohio State University Comprehensive Cancer Center contact
Laura Chambers, DO principal investigator
Ohio State University Comprehensive Cancer Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing Biospecimen Collection, Probiotic and Questionnaire Administration in people with Advanced Ovarian Carcinoma and Recurrent Ovarian Carcinoma, run by Ohio State University Comprehensive Cancer Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 17 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact The Ohio State University Comprehensive Cancer Center (800-293-5066, OSUCCCClinicaltrials@osumc.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Changes to the gut microbiome composition (time frame: Within one week before or after cycle 1 of chemotherapy, within one week before or after cycle 3 of adjuvant chemotherapy, and within one week before or after cycle 6 of adjuvant chemotherapy (cycle length = 21 days)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Aug 2026.