Clinical trial: NCT04784182
Section: Confidentiality
Subsections: Confidentiality

The information gathered during this study will be kept confidential to the extent permitted by law. Therefore, all information collected will be stored in locked file cabinets in locked study offices, or in password protected computer files that are available only to trained study staff. Study ID numbers will be assigned to study participants to protect confidentiality.
Clinical trial: NCT04784182
Section: Possible Risks, Discomforts, and Inconveniences
Subsections: Risks And Discomforts

Participation in this study may involve some risks and discomforts that are included here for your information. 1) Blood draws will cause some pain when your arm is stuck with the needle. You could feel dizzy or faint. A bruise could be left temporarily at the spot where your arm is stuck. There is a slight chance of excessive bleeding, infection, inflammation of your vein, and/or blood clot formation; these are extremely rare.  
2) You may feel some discomfort when disclosing personal information. When answering the questionnaires, you can skip any of the questions that you do not want to answer.  
3) While we will protect your privacy and the information collected about you the very best we can, there always is a small chance of a breach in confidentiality.  
4) It is possible that the synbiotic can cause gastrointestinal distress or discomfort Risk & Precautions for COVID-19 Due to the need for your physical presence at the research site, there is a risk that you may be exposed to COVID-19 and the possibility that you may contract the virus. For most people, COVID19 causes only mild or moderate symptoms. For some, especially older adults and people with existing health problems, it can cause more severe illness. Current information suggests that about 2% of people who are infected with COVID-19 might die as a result. You will need to review the Information on COVID-19 for Research Participants that is attached to this consent document. To minimize your risk of exposure we will describe precautions such as screening/rescreening of participant(s)/researcher(s), personal protection equipment for participant(s)/researcher(s), decontamination of surfaces, location configuration and distance between persons, etc. You will need to follow any precautions or procedures outlined by Auburn University and, when applicable, offsite locations.
Clinical trial: NCT04784182
Section: Procedures
Subsections: Explanation Of Procedures

This is a six-week study which involves two phases lasting 2-weeks and 4-weeks, respectively. All participants will participate in each of these phases; however, the allocation to either the synbiotic or placebo group will be random, like the flip of a coin. The entire study will require a time commitment of approximately 4 hours total over the six weeks. In the first phase, 2-week run in period, you will be instructed to avoid fermented foods such as yogurt or sauerkraut while continuing your normal diet. In the second phase, you will receive 28days worth of capsules containing either synbiotic compounds or placebo capsules containing starch. You will be asked to come to the Auburn University campus a total of three (3) times throughout the study to provide the following:
1) At the first visit, you will be asked about your medical history and medications. At all visits you will be asked about your diet and physical activity and you will be asked to complete a short survey about anxiety symptoms.  
2) Prior to each visit, you will be provided with a kit to collect a small fecal sample after a bowel movement. You will be instructed to freeze this sample and bring it with you to your next visit. We will analyze the fecal microbiome, which is the population of bacteria that live in your large intestine and whose composition may be associated with anxiety symptoms.  
3) During each visit, a trained phlebotomist will draw 15mL (1 Tablespoon) of blood from your arm. Because of the blood tests that will be performed, you will be asked to "fast," that is, to not eat or drink anything except water for 12 hours before these appointments. We will analyze different proteins in your blood that may be associated with anxiety symptoms.  
4) During each visit, we will measure your height, weight, waist, hips, and body composition using a handheld analyzer.
Clinical trial: NCT04784182
Section: Purpose of Research
Subsections: "Synbiotic Supplementation To Reduce Anxiety Symptoms|Purpose

In Female Breast Cancer Survivors"  
A description of this clinical trial is available at https://clinicaltrials.gov/ct2/show/NCT04784182, as required by U.S. Law. This website will not include information that can identify you. At most, the website will include a summary of the results. You can search this website at any time. This study is funded by the Auburn University College of Human Sciences and the University of Alabama at Birmingham Center for Clinical and Translational Science and is being conducted by Andrew D. Frugé, PhD, Auburn University Assistant Professor.

The purpose of this study is to explore the beneficial effects of a combination prebiotic and probiotic (synbiotic) supplement on anxiety symptoms in females with a family history of or have survived a breast cancer diagnosis who are currently experiencing moderate to severe anxiety.
Clinical trial: NCT04784182
Section: Voluntary Participation
Subsections: Voluntary Participation And Withdrawal

Whether or not you take part in this study is your choice. There will be no penalty if you decide not to be in the study. If you decide not to be in the study, you will not lose any benefits you are otherwise owed. You are free to withdraw from this research study at any time. Your choice to leave the study will not affect your relationship with this institution. If you are an Auburn University student or employee, taking part in this research is not a part of your Auburn University class work or duties. You can refuse to enroll, or withdraw after enrolling at any time before the study is over, with no effect on your class standing, grades, or job at Auburn University. You will not be offered or receive any special consideration if you take part in this study.