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NCT04362826 · ClinicalTrials.gov registry record · NA
Study to Investigate Efficacy of a Novel Probiotic on the Bacteriome and Mycobiome of Breast Cancer
A NA study, sponsored by Case Comprehensive Cancer Center.
- Recruiting
- Registry status
- NA
- Development phase
- 100
- Enrollment target
NCT04362826: Recruiting NA study, sponsored by Case Comprehensive Cancer Center.
NCT04362826 is a NA study that is actively recruiting participants, run by Case Comprehensive Cancer Center. The registered enrollment target is 100 participants, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (93% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04362826, a NA study, is actively recruiting participants, sponsored by Case Comprehensive Cancer Center.
- RECRUITING
- Registry status
- NA
- Development phase
- 100 participants
- Enrollment target
Study 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. 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.
Primary Outcome
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
Interventions
- OTHER Placebo
- BIOLOGICAL Novel probiotic
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 100 participants |
| Start Date | 2026-03-20 |
| Est. Completion | 2026-12 |
| Phase | NA |
What NCT04362826 shows while recruiting
NCT04362826 is an interventional study that assigns participants to a tested intervention. The registered 100 participants enrollment target is mid-sized for trials with a published cap, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (93% lower).
The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.
NCT04362826 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT04362826 about?
NCT04362826 is a clinical study titled "Study to Investigate Efficacy of a Novel Probiotic on the Bacteriome and Mycobiome of Breast Cancer". 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 associatio...
What is the current status of trial NCT04362826?
This trial is currently recruiting. It is a NA study. The enrollment target is 100 participants. The study started on 2026-03-20. Estimated completion is 2026-12.
What interventions are being tested in trial NCT04362826?
The interventions under investigation include: Placebo (OTHER), Novel probiotic (BIOLOGICAL).
Who is sponsoring clinical trial NCT04362826?
This trial is sponsored by Case Comprehensive Cancer Center, which has 407 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT04362826's enrollment target sits among peer trials
100 840th of 2000 higher than 1,081 of 2,000 other NA trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other NA trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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