A Randomized, Double-blind, Placebo Controlled, Parallel Study to Investigate Efficacy of a Novel Probiotic on the Bacteriome and Mycobiome of Breast Cancer Patients
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 100
- 试验地点
- 2
- 主要终点
- Beta-D-Glucagon levels
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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.
- •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.
研究组 & 干预措施
Novel probiotic
Investigational novel probiotic plus normal standard of care for breast cancer.
干预措施: Novel probiotic (Biological)
Placebo
Placebo plus normal standard of care for breast cancer.
干预措施: Placebo (Other)
结局指标
主要结局
Beta-D-Glucagon levels
时间窗: 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
Free amino acid levels
时间窗: 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
Short-chain fatty acid levels
时间窗: 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
次要结局
- Polymicrobial biofilm composition of gut microbiome and mycobiome(At baseline and at 6 weeks)
- Alpha and beta biodiversity of breast microbiome and mycobiome(At baseline and at 6 weeks)
- Polymicrobial biofilm composition of breast microbiome and mycobiome(At baseline and at 6 weeks)
- Alpha and beta biodiversity of gut microbiome and mycobiome(At baseline and at 6 weeks)
- Differential abundances of gut microbiome and mycobiome(At baseline and at 6 weeks)
- Differential abundances of breast microbiome and mycobiome(At baseline and at 6 weeks)
- QoL via EORTC QLQ-BR23(At baseline and at 6 weeks)
- QoL via standardized European Organization for Research and Treatment of Cancer (EORTC) QLQ-C30(At baseline and at 6 weeks)