Alethios - Oral Supplementation with a Novel Mycolicibacterium (NeuroAlly™) for Inflammation and Stress Screening

About This Study

Are you interested in contributing to research on mental health and the gut-immune-brain axis? Kioga is looking for volunteers to join a clinical study investigating the effects of a naturally occurring strain of mycolicibacterium on stress resilience and inflammation. Why This Study? Recent studies suggest that certain environmental microbes may play a key role in modulating the immune system and mental health. This research explores how supplementation with a novel strain of mycolicibacterium might enhance the body’s ability to manage stress by reducing inflammation. Location: Remote Time Commitment: 3-4 hours over the course of 10 weeks Interested? Click continue to proceed with the screening questionnaire, or contact the study investigators Chris Stamper (chris@kioga.bio) or Adam Bohr (adam@kioga.bio) to learn more and find out if you're eligible. Your participation could help pave the way for new, natural approaches to managing stress and promoting well-being. Thank you.

Screening

The purpose of this questionnaire is to determine your eligibility for participation in the study based on inclusion and exclusion criteria. The data collected will be reviewed by the principal investigator of the study to determine if you are eligible and will be stored in a database if you are selected and enrolled in the study. If you are not eligible, selected or enrolled, this data will be destroyed. Please reach out to the Chris Stamper (chris@kioga.bio) or Adam Bohr (adam@kioga.bio) if you have any questions regarding the screening survey.

What is your name?*

(First and Last Name)

What is your email?*

What is your sex?*

Please select the option that best describes your sex assigned at birth. This information is used for randomization purposes to ensure equal representation across study groups.

Male

Female

What is your date of birth?*

Are you willing and able to take a daily supplement? (Select one)*

Yes

No

Unknown

Are you willing and able to provide three at-home blood spot tests for analysis? (Select one)*

Yes

No

Unknown

Do you speak English? (Select one)*

Yes

No

Unknown

Are you currently receiving immunosuppressive drugs or treatment including antineoplastic therapy, post-transplantation immunosuppressive therapy, and/or radiation therapy? (Select one)*

Yes

No

Unknown

Do you have any current (past month) alcohol or substance abuse or dependence? (Select one)*

Yes

No

Unknown

Do you have lifetime history of bipolar disorder or psychosis? (Select one)*

Yes

No

Unknown

Have you received intravenous, intramuscular, or oral antibiotics within the last month? (Select one)*

Yes

No

Unknown

Are you receiving medications that interfere with gut motility (opiates, loperamide, stool softeners)? (Select one)*

Yes

No

Unknown

Do you have central venous catheters (CVCs)? (Select one)*

Yes

No

Unknown

Are you participating in conflicting interventional research protocol? (Select one)*

Yes

No

Unknown

Are you currently enrolled in any other clinical trials, supplement studies or other consumer health studies?*

Note, if you are enrolled in any other studies on Alethios, you will be automatically deemed ineligible for this study, and will not be able to complete this eligibility form again.

Yes

No

Have you participated in any other clinical trial, supplement study or health study in the last 7 days?*

Note, if you were enrolled in any other studies in the above specified timeline via the Alethios platform, you will be automatically deemed ineligible for this study, and will not be able to complete this pre-screener again. If you are completing a study soon and would like to be enrolled in this study, you may wait till completion and return to this screener if the study is still enrolling.

Yes

No

Have you used of any of the following drugs within the last 6 months:*

Systemic antibiotics, antifungals, antivirals or antiparasitics (intravenous, intramuscular, or oral); oral, intravenous, intramuscular, nasal or inhaled corticosteroids; cytokines or cytokine inhibitors; methotrexate or immunosuppressive cytotoxic agents? (Select one)

Yes

No

Unknown

Are you currently sick? (Select one)*

Yes

No

Unknown

Do you have any chronic, clinically significant (unresolved, requiring ongoing medical management or medication) pulmonary, cardiovascular, gastrointestinal, hepatic or renal functional abnormality? (Select one)*

Yes

No

Unknown

Do you have history of cancer except for squamous or basal cell carcinomas of the skin that have been medically managed by local excision? (Select one)*

Yes

No

Unknown

Do you have a positive test for human immunodeficiency virus (HIV), Hepatitis B virus, or Hepatitis C virus? (Select one)*

Yes

No

Unknown

Have you had major surgery of the GI tract, with the exception of cholecystectomy and appendectomy, in the past five years. Any major bowel resection at any time? (Select one)*

Yes

No

Unknown

Are you a female who is pregnant or lactating? (Select one)*

Yes

No

Unknown

Perceived Stress Scale

In the last month, how often have you been upset because of something that happened unexpectedly?*

0 - Never

1 - Almost never

2 - Sometimes

3 - Fairly often

4 - Very often

In the last month, how often have you felt that you were unable to control the important things in your life?*

0 - Never

1 - Almost never

2 - Sometimes

3 - Fairly often

4 - Very often

In the last month, how often have you felt nervous and "stressed"?*

0 - Never

1 - Almost never

2 - Sometimes

3 - Fairly often

4 - Very often

In the last month, how often have you felt confident about your ability to handle your personal problems?*

0 - Never

1 - Almost never

2 - Sometimes

3 - Fairly often

4 - Very often

In the last month, how often have you felt that things were going your way?*

0 - Never

1 - Almost never

2 - Sometimes

3 - Fairly often

4 - Very often

In the last month, how often have you found that you could not cope with all the things that you had to do?*

0 - Never

1 - Almost never

2 - Sometimes

3 - Fairly often

4 - Very often

In the last month, how often have you been able to control irritations in your life?*

0 - Never

1 - Almost never

2 - Sometimes

3 - Fairly often

4 - Very often

In the last month, how often have you felt that you were on top of things?*

0 - Never

1 - Almost never

2 - Sometimes

3 - Fairly often

4 - Very often

In the last month, how often have you been angered because of things that were outside of your control?*

0 - Never

1 - Almost never

2 - Sometimes

3 - Fairly often

4 - Very often

In the last month, how often have you felt difficulties were piling up so high that you could not overcome them?*

0 - Never

1 - Almost never

2 - Sometimes

3 - Fairly often

4 - Very often

Contact Information

Please enter your Mailing Address.*

This is required for us to send you your study kit.

What is your phone number?*

Timeline Explanation

Once you have completed this screening questionnaire, it may take up to 3-4 weeks for the team to review your submission. You will receive an email notifying you of your eligibility status when the study is about to begin, at which point you will be invited to review and sign the study's consent forms, complete onboarding tasks and wait to receive the study kit.