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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03358511
Other study ID # 17-002215
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date October 11, 2017
Est. completion date May 19, 2020

Study information

Verified date May 2020
Source Mayo Clinic
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

The purpose of this study is to find out if using probiotics will help the body's immune system react to breast cancer. New studies showed that diverse species of bacteria inside the bowel might help improve immune system, particularly the ability of immune system to recognize cancer. This study will investigate how probiotics will affect the subjects' immune system on breast cancer.


Recruitment information / eligibility

Status Completed
Enrollment 7
Est. completion date May 19, 2020
Est. primary completion date March 24, 2020
Accepts healthy volunteers No
Gender Female
Age group 18 Years and older
Eligibility Inclusion Criteria:

- Post-menopausal females = 18 years of age

- Histologically confirmed adenocarcinoma of the breast =1.0 cm operable stage I-III

- Must have adequate organ function,

- Not receive systemic neoadjuvant therapy

- Be willing to provide tissue, blood, and stool samples for research study.

- Must not have taken any probiotics in the past 60 days prior to enrollment.

Exclusion Criteria:

- Patients with autoimmune disease, immune deficiency such as HIV, irritable bowel, known diverticulosis, and other serious GI conditions at treating physician's discretion will be excluded.

Study Design


Related Conditions & MeSH terms


Intervention

Dietary Supplement:
Probiotic
Primal Defense Ultra® Probiotic Formula is an over-the-counter probiotic that provides 15 billion colony forming units of 13 species of beneficial bacteria, including Saccharomyces boulardii, Lactobacillus plantarum, Bacillus subtilis, Bifidobacterium lactis, Bifidobacterium bifidum, Lactobacillus rhamnosus, Bifidobacterium breve, lactobacillus casei, Lactobacillus salivarius, Lactobacillus acidophilus, Lactobacillus brevis, Bifidobacterium longum, and Lactobacillus paracasei.

Locations

Country Name City State
United States Mayo Clinic in Florida Jacksonville Florida

Sponsors (1)

Lead Sponsor Collaborator
Mayo Clinic

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Mean number of cytotoxic T lymphocytes (CD8+ cells) CD8+ T cells (often called cytotoxic T lymphocytes) are very important for immune defence against intracellular pathogens, including viruses and bacteria, and for tumor surveillance. Approximately 4 weeks after baseline
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