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Probiotic

Probiotic for Breast Cancer

N/A

Waitlist Available

Led By Charis Eng, MD, PhD, FACP

Research Sponsored by Case Comprehensive Cancer Center

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Minimum breast tumor size of 1.0 cm

Diagnosis of breast cancer (invasive ductal carcinoma [IDC] or Invasive Lobular Carcinoma [ILC])

Timeline

Screening 3 weeks

Treatment Varies

Follow Up at baseline and at 6 weeks

Awards & highlights

Study Summary

This trial will test whether the probiotic BIOHM can help prevent breast cancer or improve outcomes in people who have breast cancer.

Who is the study for?

This trial is for adults with a breast tumor size of at least 1.0 cm and diagnosed with invasive ductal or lobular carcinoma, who are not pregnant, breastfeeding, or planning pregnancy during the study. Participants must have a BMI between 18.5 to 29.9 kg/m2, avoid unpasteurized fermented foods and probiotics before and during the trial, maintain current diet/exercise levels, agree to use birth control if applicable, and sign informed consent.Check my eligibility

What is being tested?

The study tests BIOHM probiotic's effect on the microbiome in breast cancer patients compared to a placebo. BIOHM aims to balance gut bacteria/fungi and is FDA-recognized as safe (GRAS). The goal is to see if it can influence microorganisms associated with breast cancer development.See study design

What are the potential side effects?

Since BIOHM is considered safe by FDA standards (GRAS), significant side effects are not expected; however minor digestive changes may occur due to alterations in gut flora from taking the novel probiotic.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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My breast tumor is at least 1.0 cm in size.

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I have been diagnosed with a type of breast cancer.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ at baseline and at 6 weeks

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~at baseline and at 6 weeks

This trial's timeline: 3 weeks for screening, Varies for treatment, and at baseline and at 6 weeks for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Beta-D-Glucagon levels

Free amino acid levels

Short-chain fatty acid levels

Secondary outcome measures

Alpha and beta biodiversity of breast microbiome and mycobiome

Alpha and beta biodiversity of gut microbiome and mycobiome

Differential abundances of breast microbiome and mycobiome

+5 more

Trial Design

2Treatment groups

Experimental Treatment

Placebo Group

Group I: Novel probioticExperimental Treatment1 Intervention

Investigational novel probiotic plus normal standard of care for breast cancer.

Group II: PlaceboPlacebo Group1 Intervention

Placebo plus normal standard of care for breast cancer.

0 / 2Eligibility criteria met

Find a Location

Who is running the clinical trial?

Case Comprehensive Cancer CenterLead Sponsor

452 Previous Clinical Trials

31,810 Total Patients Enrolled

54 Trials studying Breast Cancer

4,867 Patients Enrolled for Breast Cancer

Charis Eng, MD, PhD, FACPPrincipal InvestigatorCleveland Clinic Taussig Cancer institute, Case Comprehensive Cancer Center

Zahraa Al-Hilli, MDPrincipal InvestigatorCleveland Clinic Taussig Cancer institute, Case Comprehensive Cancer Center

1 Previous Clinical Trials

100 Total Patients Enrolled

1 Trials studying Breast Cancer

100 Patients Enrolled for Breast Cancer

Media Library

Breast Cancer Research Study Groups: Novel probiotic, Placebo

Novel probiotic (Probiotic) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04362826 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Who is eligible to enrol in this experiment?

"This clinical trial is searching for 100 people aged 18-65 with breast cancer. Several criteria must be met by applicants, such as the use of medically approved contraception and a negative pregnancy test result, diagnosis of IDC or ILC, minimum tumor size of 1 cm., BMI in between 18.5 to 29.9 kg/m2, abstaining from consuming unpasteurized bacteria-fermented foods one week prior to baseline visit and throughout the study, not changing dietary habits apart from avoiding probiotics one week prior to screening and during the study; agreeing to complete all research activities defined in the study; having ability to understand and willingness"

Answered by AI

What are the primary objectives of this experiment?

"Benchmarking this experiment will be Beta-D-Glucagon levels, taken at the onset and again after six weeks. Secondary goals include investigating Polymicrobial biofilm composition of gut microbiome and mycobiome through bacteriome in stool; Alpha and beta biodiversity of gut microbiome and mycobiome by examining bacteriome in stool; as well lastly surveying Alpha and beta biodiversity of breast microbiome and mycobiome via bacteriome in breast tissue."

Answered by AI

Is there currently an open enrollment period for this research endeavor?

"Clinicaltrials.gov reports that this trial is not presently seeking out patients; it was initially posted on December 1st 2022 and lastly modified on October 14th 2022. Despite the fact that recruitment has been suspended, there are 2602 trials actively recruiting participants currently."

Answered by AI

Is the target population of this clinical trial restricted to those aged 65 and over?

"Applicants must fall between 18 and 65 years old to be eligible for this clinical trial. For those below the age of majority, there are 74 studies available while 2507 trials exist for seniors."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Study to Investigate Efficacy of a Novel Probiotic on the Bacteriome and Mycobiome of Breast Cancer

2024. "Study to Investigate Efficacy of a Novel Probiotic on the Bacteriome and Mycobiome of Breast Cancer". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04362826.