Breast CancerNCT04362826
Study to Investigate Efficacy of a Novel Probiotic on the Bacteriome and Mycobiome of Breast Cancer
A study testing Novel probiotic in people with Breast Cancer, run by Case Comprehensive Cancer Center at 1 site in United States.
Trial summary
The purpose of this study is to examine the effect of probiotics on the breast tumor microbiome and gut microbiome in breast cancer. Microorganisms that make up the microbiome (such as viruses, bacteria, and fungi) may have an important role in breast cancer development. Read more about this study
- Who is it for?
- Ages 18 to 65 years, women only
- Conditions the study is for
- Breast Cancer
- What is being tested?
- Novel probiotic
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 100 participants
- Where
- 1 siteUnited States
- Study dates
- 20 Mar 2026to Dec 2026
- Phase
- Interventional
- 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 to 65 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Female > 18 years of age
- Diagnosis of breast cancer (invasive ductal carcinoma [IDC] or Invasive Lobular Carcinoma [ILC])
- Minimum breast tumor size of 1.0 cm
- Participants who are of childbearing potential must agree to use a medically approved method of birth control and have a negative pregnancy test result
- Agree to abstain from consuming unpasteurized bacteria-fermented foods one week prior to baseline visit and throughout the study (example list provided and reviewed during informed consent process).
- Agree to not change current dietary habits (apart from avoiding probiotics) and activity/training levels one week prior to screening and during the study.
- Agree to complete all research activities defined in the study
- Participants must have the ability to understand and the willingness to sign a written informed consent document.
Who cannot join
- Women who are pregnant, breast feeding, or planning to become pregnant during the trial.
- Use of antibiotics within 5 weeks of randomization.
- History of chronic inflammation or structural abnormality of the digestive tract (e.g., inflammatory bowel disease, duodenal or gastric ulcer intestinal obstruction, or symptomatic cholelithiasis).
- Use of probiotic and/or prebiotic supplements and/or supplemented foods prior to screening and throughout the study.
- Individuals receiving any other investigational agents within 30 days prior to randomization.
- Change in anti-psychotic medication within 3 months prior to randomization.
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- Alcohol or drug abuse in the past year.
- Participants with a known allergy to the test material's active or inactive ingredients..
- Clinically significant abnormal laboratory results that may negatively impact the participant being involved on the study, at the discretion of the physician.
- Any condition which in the investigators' opinions may adversely affect the participant's ability to complete the study or its measures or which may pose significant risk to the participant.
- Physician feels participation in this trial is not in the subject's best interest.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Cleveland Clinic Taussig Cancer institute, Case Comprehensive Cancer Center
Cleveland, Ohio, 44122
Charis Eng, MD, +1 216-444-3440, engc@ccf.org
Charis Eng, MD, PhD, FACP
About this study
Official title: A Randomized, Double-blind, Placebo Controlled, Parallel Study to Investigate Efficacy of a Novel Probiotic on the Bacteriome and Mycobiome of Breast Cancer Patients
The purpose of this study is to examine the effect of probiotics on the breast tumor microbiome and gut microbiome in breast cancer. Microorganisms that make up the microbiome (such as viruses, bacteria, and fungi) may have an important role in breast cancer development. Understanding the association of microorganisms with breast cancer may enable new ways to prevent, diagnose, and treat breast cancer.
The probiotic, BIOHM, which is owned and distributed by BIOHM Health LLC, will be used in this study. BIOHM is a food supplement that is believed to balance bacteria and fungi in the body and has received the designation as Generally Recognized as Safe (GRAS) by the Food and Drug Administration (FDA). This study is being done to determine the effectiveness of BIOHM in breast cancer.
Read the detailed description
This study will investigate the efficacy of the investigational product (a novel probiotic) on altering the microbiome (bacteriomeand mycobiome) and polymicrobial biofilms in the gut of 50 women with breast cancer given the novel probiotic, compared to 50 women with breast cancer given a placebo.
The objectives of this study are to:
- Determine the efficacy profile of the novel probiotic
- Analyze bacteriome and mycobiome profiles as well as polymicrobial biofilm composition from breast tissue and stool before and after consumption of the probiotic.
- Compare quality of life (QoL) of those receiving novel probiotic compared to placebo.
- Conditions
- Breast Cancer
- Being tested
- Novel probiotic, Placebo
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Novel probioticBiological
Investigational novel probiotic
PlaceboOther
Placebo for probiotic
| Study group | Role | What they receive |
|---|---|---|
| Novel probiotic | Experimental | Investigational novel probiotic plus normal standard of care for breast cancer. Receives: Biological: Novel probiotic |
| Placebo | Placebo comparator | Placebo plus normal standard of care for breast cancer. Receives: Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Beta-D-Glucagon levels
Efficacy of the novel probiotic as defined by change in Beta-D-Glucagon levels. This biomarker is well established to measure shifts in the mycobiome
Measured: At baseline and at 6 weeks
Short-chain fatty acid levels
Efficacy of the novel probiotic as defined by change in short-chain fatty acid levels. This biomarker is well established to measure shifts in the bacteriome
Measured: At baseline and at 6 weeks
Free amino acid levels
Efficacy of the novel probiotic as defined by change in free amino acid levels. This biomarker is well established to measure shifts in the bacteriome
Measured: At baseline and at 6 weeks
Secondary outcomes (8)
Alpha and beta biodiversity of gut microbiome and mycobiome
Gut microbiome and polymicrobioal biofilm composition analyzed through bacteriome in stool as measured by alpha and beta biodiversity
Measured: At baseline and at 6 weeks
Differential abundances of gut microbiome and mycobiome
Gut microbiome and polymicrobioal biofilm composition analyzed through bacteriome in stool as measured by differential abundances
Measured: At baseline and at 6 weeks
Polymicrobial biofilm composition of gut microbiome and mycobiome
Gut microbiome and polymicrobioal biofilm composition analyzed through bacteriome in stool as measured by polymicrobioal biofilm composition
Measured: At baseline and at 6 weeks
Alpha and beta biodiversity of breast microbiome and mycobiome
Gut microbiome and polymicrobioal biofilm composition analyzed through bacteriome in breast tissue as measured by alpha and beta biodiversity
Measured: At baseline and at 6 weeks
Differential abundances of breast microbiome and mycobiome
Gut microbiome and polymicrobioal biofilm composition analyzed through bacteriome in breast tissue as measured by differential abundances
Measured: At baseline and at 6 weeks
Polymicrobial biofilm composition of breast microbiome and mycobiome
Gut microbiome and polymicrobioal biofilm composition analyzed through bacteriome in breast tissue as measured by polymicrobioal biofilm composition
Measured: At baseline and at 6 weeks
QoL via standardized European Organization for Research and Treatment of Cancer (EORTC) QLQ-C30
Quality of life (QoL) via EORTC QLQ C-30 will be converted into dimensions, which evaluate the quality of life associated with health. Dimensions are expected to range 0-100, with high scores referring to higher responses (QoL, symptoms) and are described by the arithmetic mean and standard deviation. Mann-Whitney U test will be utilized to compare the dimensions between each of the 2 groups (probiotic vs placebo groups). For testing the statistical significance of the change in dimensions before and after treatment (within probiotic arm; within placebo arm), the Wilcoxon signed rank test will be used. P<0.05 will be considered statistically significant.
Measured: At baseline and at 6 weeks
QoL via EORTC QLQ-BR23
EORTC QLQ-BR23 will be converted into dimensions, which evaluate the quality of life associated with health. Dimensions are expected to range 0-100 with high scores referring to higher responses (QoL, symptoms) and are described by the arithmetic mean and standard deviation. Mann-Whitney U test will be utilized to compare the dimensions between each of the 2 groups (probiotic vs placebo groups). For testing the statistical significance of the change in dimensions before and after treatment (within probiotic arm; within placebo arm), the Wilcoxon signed rank test will be used. P<0.05 will be considered statistically significant.
Measured: At baseline and at 6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Apr 2020
- Study start20 Mar 2026
- Primary completionDec 2026 (estimated)
- Study completionDec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast CancerStudies of the same condition, open and under way.
- More trials run by Case 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
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Case Comprehensive Cancer Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Zahraa Al-Hilli, MD, Principal investigator, Cleveland Clinic Taussig Cancer institute, Case Comprehensive Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04362826
- Sponsor's protocol ID
- CASE13119
- Status last verified
- Sep 2026
- First submitted
- 23 Apr 2020
- Last updated
- 15 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: All IPD that underlie results in publication
Study at a glance
From the registry record, last updated by the sponsor on 15 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Double-blind, Placebo Controlled, Parallel Study to Investigate Efficacy of a Novel Probiotic on the Bacteriome and Mycobiome of Breast Cancer Patients
- ClinicalTrials.gov ID
- NCT04362826
- Acronym / sponsor ID
- CASE13119
- Conditions
- Breast Cancer
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Case Comprehensive Cancer CenterUniversity, hospital or other
- Study start
- 20 Mar 2026 (actual)
- Primary completion
- Dec 2026 (estimated)
- Study completion
- Dec 2026 (estimated)
- First posted
- 27 Apr 2020 (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.
The purpose of this study is to examine the effect of probiotics on the breast tumor microbiome and gut microbiome in breast cancer. Microorganisms that make up the microbiome (such as viruses, bacteria, and fungi) may have an important role in breast cancer development. Understanding the association of microorganisms with breast cancer may enable new ways to prevent, diagnose, and treat breast cancer.
The probiotic, BIOHM, which is owned and distributed by BIOHM Health LLC, will be used in this study. BIOHM is a food supplement that is believed to balance bacteria and fungi in the body and has received the designation as Generally Recognized as Safe (GRAS) by the Food and Drug Administration (FDA). This study is being done to determine the effectiveness of BIOHM in breast cancer.
Detailed description
This study will investigate the efficacy of the investigational product (a novel probiotic) on altering the microbiome (bacteriomeand mycobiome) and polymicrobial biofilms in the gut of 50 women with breast cancer given the novel probiotic, compared to 50 women with breast cancer given a placebo.
The objectives of this study are to:
- Determine the efficacy profile of the novel probiotic
- Analyze bacteriome and mycobiome profiles as well as polymicrobial biofilm composition from breast tissue and stool before and after consumption of the probiotic.
- Compare quality of life (QoL) of those receiving novel probiotic compared to placebo.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Novel probiotic | Experimental | Biological: Novel probioticInvestigational novel probiotic plus normal standard of care for breast cancer. |
| Placebo | Placebo comparator | Other: PlaceboPlacebo plus normal standard of care for breast cancer. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Female > 18 years of age
- Diagnosis of breast cancer (invasive ductal carcinoma [IDC] or Invasive Lobular Carcinoma [ILC])
- Minimum breast tumor size of 1.0 cm
- Participants who are of childbearing potential must agree to use a medically approved method of birth control and have a negative pregnancy test result
- Agree to abstain from consuming unpasteurized bacteria-fermented foods one week prior to baseline visit and throughout the study (example list provided and reviewed during informed consent process).
Key exclusion criteria (11 listed)
- Women who are pregnant, breast feeding, or planning to become pregnant during the trial.
- Use of antibiotics within 5 weeks of randomization.
- History of chronic inflammation or structural abnormality of the digestive tract (e.g., inflammatory bowel disease, duodenal or gastric ulcer intestinal obstruction, or symptomatic cholelithiasis).
- Use of probiotic and/or prebiotic supplements and/or supplemented foods prior to screening and throughout the study.
- Individuals receiving any other investigational agents within 30 days prior to randomization.
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 |
|---|---|---|
| Novel probioticInvestigational novel probiotic | Biological | Novel probiotic |
| PlaceboPlacebo for probiotic | Other | Placebo |
Primary outcome
Beta-D-Glucagon levels
Time frame: At baseline and at 6 weeks
Efficacy of the novel probiotic as defined by change in Beta-D-Glucagon levels. This biomarker is well established to measure shifts in the mycobiome
Short-chain fatty acid levels
Time frame: At baseline and at 6 weeks
Efficacy of the novel probiotic as defined by change in short-chain fatty acid levels. This biomarker is well established to measure shifts in the bacteriome
Free amino acid levels
Time frame: At baseline and at 6 weeks
Efficacy of the novel probiotic as defined by change in free amino acid levels. This biomarker is well established to measure shifts in the bacteriome
8 secondary outcomes
Alpha and beta biodiversity of gut microbiome and mycobiome
Time frame: At baseline and at 6 weeks
Differential abundances of gut microbiome and mycobiome
Time frame: At baseline and at 6 weeks
Polymicrobial biofilm composition of gut microbiome and mycobiome
Time frame: At baseline and at 6 weeks
Alpha and beta biodiversity of breast microbiome and mycobiome
Time frame: At baseline and at 6 weeks
Differential abundances of breast microbiome and mycobiome
Time frame: At baseline and at 6 weeks
Polymicrobial biofilm composition of breast microbiome and mycobiome
Time frame: At baseline and at 6 weeks
QoL via standardized European Organization for Research and Treatment of Cancer (EORTC) QLQ-C30
Time frame: At baseline and at 6 weeks
QoL via EORTC QLQ-BR23
Time frame: At baseline and at 6 weeks
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 15 Sep 2026.
- Individual participant dataSharing planned: Yes. All IPD that underlie results in publication
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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.
Zahraa Al-Hilli, MD principal investigator
Cleveland Clinic Taussig Cancer institute, Case 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 study testing Novel probiotic in people with Breast Cancer, run by Case 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 8 inclusion and 11 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 15 Sep 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.
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 Zahraa Al-Hilli, MD (+1 216-444-3440, alhillz@ccf.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Beta-D-Glucagon levels (time frame: At baseline and at 6 weeks). The study lists 3 primary outcomes in all. 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 15 Sep 2026.