Welcome. You are invited to take part in a research study hosted on the Efforia platform. This study is designed to help you test a daily gut-brain probiotic routine over 90 days and track what changes for you using structured surveys and outcome reports. Please read this consent form carefully — it is meant to help you decide whether to participate.

Your participation in this research study is voluntary. Refusing to participate will not alter your usual health care or involve any penalty or loss of benefits to which you are entitled. If you decide to join the study, you may withdraw at any time and for any reason without penalty or loss of benefits. You may leave the study at any time by emailing help@efforia.com.

Please ask any questions you have before you decide. You can contact help@efforia.com or use the online chat. If any part of this study does not make sense for your personal situation, do not join.

Efforia is a citizen science platform where studies are effectively sponsored by you, the participants. Unlike traditional research studies, you pay for all the supplies, services, information, and tools needed for participation in one transaction. This makes studies possible that might not be otherwise.

Although you could buy these products and services separately for a similar cost, Efforia bundles them into one purchase for convenience. Efforia organizes these items and provides instructions to create a comprehensive, data-driven research experience. This setup allows you to track and understand the impact on your own life via detailed outcome reports, making informed personal health decisions easier. It also advances broader research findings, benefiting others who might not afford such purchases without guaranteed results.

Efforia is committed to equitable inclusion. If the cost is too high for you, click the large Efforia logo at the top of the screen to explore other protocols. Efforia offers protocols on various topics at different price points, including free options, so you can find one that suits your goals and budget.

The purpose of this study is to evaluate how a daily gut-brain probiotic supplement — Neuralli Mood — may relate to changes in anxiety, sleep quality, mood, and feelings of burnout over 90 days. The study aims to build structured personal evidence for each participant while contributing to the emerging science on gut-based interventions for stress recovery.

This is a single-arm, longitudinal study. There is no separate control group. You act as your own control by comparing your own baseline measures to your follow-up measures over time.

Products and services in this study (definitions):

• Neuralli Mood – 90 Days Supply: A probiotic dietary supplement targeting the gut-brain axis. It is taken as 2 capsules daily and must be stored in the refrigerator. It is formulated with specific bacterial strains intended to support mood and stress resilience via the gut-brain connection. Review the full ingredient list on the product label before enrolling. If you have known allergies or sensitivities to probiotic ingredients, do not join without speaking to your physician.
• Bened Life Gift Card – $100.00: A gift card provided as part of this protocol, usable toward Bened Life products.

Outcome measures in this study (definitions):

• Depression, Anxiety and Stress Scales (DASS-21): A 21-item validated questionnaire that measures the severity of core symptoms of depression, anxiety, and stress over the past week.
• Burnout Assessment Survey: A validated questionnaire that measures key dimensions of occupational burnout, including exhaustion, mental distancing, emotional impairment, and cognitive impairment.
• Oxford Happiness Questionnaire: A validated 29-item questionnaire measuring subjective happiness and wellbeing across multiple dimensions.
• Sleep Quality Survey: A structured questionnaire measuring subjective sleep quality, sleep duration, sleep disturbances, and daytime dysfunction over a recent time period.

While participating in this research study, you will need to:

• Be willing and able to follow the study directions and procedures.
• Tell Efforia about any side effects or problems by communicating with help@efforia.com or online chat.
• Ask questions as you think of them, via help@efforia.com or online chat.
• Inform Efforia if you change your mind about staying in the study. You may leave at any time by communicating with help@efforia.com or chat.

After you complete enrollment and payment, and after you enter your personal details, shipping details, and communication preferences, your participation will include the activities below for approximately 90 days:

• Protocol Introduction (Getting Started):
  • Review the protocol welcome and overview.
  • Complete Your Goals & Expectations survey (Treatment Expectancy Survey).
  • Complete the More About You background survey.
  • Complete baseline versions of all four outcome surveys: the DASS-21, Burnout Assessment Survey, Oxford Happiness Questionnaire, and Sleep Quality Survey.
• Daily Routine (throughout the 90 days):
  • Take 2 capsules of Neuralli Mood daily. Consistency matters more than timing — pick a moment that is easy to repeat and stick with it. Keep the bottle refrigerated.
  • If you miss a day, do not double up. Simply resume the next day.
  • Complete Safety Check-in surveys as prompted throughout the protocol.
• Follow-up Measurements (as prompted during/after the protocol):
  • Repeat versions of all four outcome surveys at designated follow-up points during the 90-day period.

You may receive notifications by e-mail, SMS, push notification, or within the platform when study tasks are available.

There are some unique risks, discomforts, and potential benefits of being in this study that you should understand before deciding to participate.

Possible Serious Adverse Events & Side Effects

Risk name	Risk likelihood	Summary
Gastrointestinal upset (bloating, gas, loose stools, nausea)	Low–Medium	Probiotics commonly cause temporary GI symptoms when first introduced, particularly in the first 1–2 weeks of use. These typically resolve on their own.
Allergic reaction (rash, hives, swelling)	Low	Some individuals may react to ingredients in the probiotic capsule, including the bacterial strains, capsule material, or excipients.
Worsening of mood or anxiety symptoms	Low	Although the supplement is intended to support mood, some individuals — particularly those with existing mental health conditions — may experience temporary changes in mood or anxiety level.
Sleep disruption	Low	Some participants may initially notice changes in sleep patterns as the gut microbiome adjusts to the probiotic.
Infection risk in immunocompromised individuals	Low (but higher in specific populations)	In rare cases, live bacteria from probiotic supplements have caused infections in people with significantly weakened immune systems. This risk is very low in healthy adults.
Unknown risks	Unknown	The gut-brain axis is an active area of research. Not all effects of probiotic supplementation are fully understood, and some risks may not yet be known.

Some People May be at Increased Risk

Some people may be at increased risk from this study and should not join before speaking with a medical professional with intimate knowledge of their specific circumstances. Without such approval, Efforia strongly encourages you not to join the study or use the associated products outside the study.

Who may be at increased risk	Why they should not join without individualized professional guidance
Immunocompromised individuals (e.g., those undergoing chemotherapy, organ transplant recipients, people with HIV/AIDS)	Live bacterial strains in probiotics pose an elevated infection risk in people with significantly weakened immune systems.
Pregnant, thinking of becoming pregnant, or breastfeeding	Limited safety data exists on probiotic supplementation during pregnancy and breastfeeding; potential effects on the fetus or infant are not fully established.
Individuals with serious gastrointestinal conditions (e.g., Crohn’s disease, ulcerative colitis, short bowel syndrome, intestinal perforation)	GI conditions may increase susceptibility to adverse effects from probiotic supplementation, including worsening symptoms or, in rare cases, systemic bacterial translocation.
Individuals with current or past mental health disorders (e.g., clinical depression, anxiety disorder, PTSD)	The study’s focus on mood and stress metrics, combined with potential gut-brain effects of the supplement, may affect mental health symptoms in sensitive individuals.
Individuals taking immunosuppressant medications	These medications reduce the body’s ability to fight infection, which may increase risk from live bacterial supplementation.
Individuals taking medications for mood, anxiety, or sleep	Potential interactions between probiotic gut-brain effects and psychoactive medications are not fully characterized; consult a physician before enrolling.
People with central venous catheters or other implanted devices	There have been rare reports of probiotic-related bloodstream infections in individuals with indwelling catheters.
Those with known allergies to probiotic ingredients or dairy-derived supplements	Allergic reactions may occur; review the full ingredient list before enrolling.

Consider your Own Risk-Benefit Comfort Level

Before you enroll, carefully weigh the possible risks and possible benefits of participation. This study places more responsibility on you to make the right choice than a traditionally sponsored clinical trial, because you are choosing to participate and paying for the bundled items used in the study.

It is possible that not all risks and benefits are currently known. Participants have the responsibility to consult with their healthcare providers and conduct further research before enrolling in the study.

Privacy & Security Risks

Efforia is doing everything we can think of to keep your data private and confidential. However, there is no such thing as “no risk.” We encourage you to review the Efforia general privacy policy here: https://efforia.com/privacy-policy/

• If we have reason to believe you may be a harm to yourself and/or others, we may reach out to local help or appropriate services.
• Regulators (for example, the FDA or similar agencies) or Institutional Review Boards may review records that contain identifying information as part of oversight activities.

The Possible Benefits of Participating – Personal and Overall Findings

Efforia will provide you with both personal outcomes and overall findings. These findings may be made available at various data collection points in your experience in the study or as they are discovered by Efforia. The results and findings may impact your interest and willingness to continue in the study. Participation is voluntary and you may exit at any time by emailing help@efforia.com.

Potential benefits may include a structured, personalized view of how Neuralli Mood affects your anxiety, sleep, mood, and burnout over 90 days — information you could not easily get otherwise. Your participation may also contribute to the growing evidence base on gut-brain interventions for stress recovery.

There is also a possibility that there will be no measurable benefit to you, other than seeing reports that the intervention had no measurable impact.

If you believe you have a study-related injury or a concerning side effect, seek local medical care first, if necessary. Efforia cannot provide emergency medical care or diagnosis. After you receive any necessary treatment, it is very important to contact Efforia at help@efforia.com or via online chat to report what happened. We want to make sure others are aware of potential risks and that study records are accurate.

Study related injury care and compensation

Efforia will not offer financial compensation nor absorb the costs of medical treatment should you be injured as a result of participating in this research. Efforia makes no commitment to provide free medical care or payment for any study related injury as a result of participation in this study.

In the case of medical emergency

In the case of medical emergency please dial 911 immediately. Do not attempt to contact Efforia until after the emergency has passed. Access local in-person medical assistance immediately.

If at any time you feel like you may be a danger to yourself or others, please dial 988 for the National Suicide Prevention Lifeline. Help is available.

Because this study is for research only, the main alternative is not to be in the study. You may choose not to participate. If this study does not seem right for your specific goals, comfort level, or budget, Efforia is dedicated to making other studies available. You may click on the Efforia logo in the upper portion of the page and find a different study that may be more appropriate.

Ethical Considerations: Efforia upholds the same high ethical standards in research as seen in pharmaceutical and academic studies, despite only hosting and not sponsoring or conducting these studies. Your participation in this study is completely voluntary, and you are free to withdraw at any time without any adverse consequences. You are not giving up any rights by signing this document.

Your participation in this research study is voluntary. Refusing to participate will not alter your usual health care or involve any penalty or loss of benefits to which you are entitled. If you decide to join the study, you may withdraw at any time and for any reason without penalty or loss of benefits.

Privacy and Confidentiality: The researchers will only use and share information that is needed for the study. Researchers will protect your information, as required by law. Absolute confidentiality cannot be guaranteed because people outside the study team may need to look at your study records. The Efforia Institutional Review Board may review your study records, and other agencies, committees, and offices that review and monitor research studies may also review them. The purpose of using and sharing your information is to make sure the study is done properly.

By signing this consent form, you are giving permission for Efforia to use and share your health information. If you decide not to sign the form, you cannot be in the study.

Right to Your Own Results: Participants have the right to a complete explanation of the research once their involvement concludes, particularly if the study involves any form of deception like placebos or controls. Efforia also aims to make personal results and broader study findings available as appropriate over time.

The Right to Leave a Study without Penalty at Any time: If you decide to withdraw from the study, you can do so at any time by visiting your Profile page, selecting “Your Protocols,” and clicking “Leave.” Upon leaving, you will be refunded for any consumable products that have not yet been shipped. For non-consumable products, a full refund will be issued upon their return in accordance with our return policy. This ensures that you can participate in the study with the assurance that your financial contributions are handled fairly and with respect for your consumer rights.

If information generated from this study is published or presented, your identity will not be revealed. In the event new information becomes available that may affect the risk or benefit associated with this study or your willingness to participate in it, you will be notified so that you can decide whether or not to continue participating.

As part of our commitment to ethical conduct and transparency in this citizen science clinical trial, it is essential to disclose the unique structure of this study. This clinical trial is hosted by Efforia, but it is uniquely sponsored by you, the participants. Efforia serves solely as the platform provider and does not sponsor or influence the study outcomes.

How Efforia makes money on this protocol: Efforia takes a transaction fee on all the products and services included in this protocol. Otherwise, Efforia has no financial interest in your results and no additional conflict of interest in whether this study shows benefit, no benefit, or mixed findings. To further reduce conflicts of interest, Efforia will remind you once if you do not complete enrollment in this study. Efforia will not remarket to you, nor otherwise push you to join the study.

How we Reduce Conflicts of Interest: You also have a role in reducing conflicts of interest. It is crucial that participants do not have any financial relationship with the intervention methods or measurement providers used in the trial, and are not employees, investors, stakeholders, or protocol authors associated with these entities. Participation under such conflicts of interest could significantly compromise the study’s integrity and the validity of its results.

Consequences of Conflict of Interest Non-Compliance: Should you fail to disclose such a conflict of interest, or if a breach of this policy is discovered, you will be subject to immediate suspension from this platform and payments may not be refunded.

By joining this trial, you affirm that you understand the above conflict of interest restrictions and agree to comply fully with them. Your participation is valued, and your adherence to these guidelines ensures the validity and reliability of our collective scientific efforts.

Data from this study may include information you provide directly (such as survey responses), account information, communications preferences, and operational data needed to run the study. Efforia uses this information to operate the study, provide your individual results, analyze pooled findings across participants, improve study operations, and meet legal, safety, ethical, and regulatory obligations. Data protections are designed to comply with applicable data protection laws and research oversight expectations.

What you can do to improve your privacy and security: As part of participating in this study, you will receive notifications via e-mail, SMS, or push notification when new study tasks like surveys and reminders are ready for you. You can adjust your communication preferences in the Efforia application at any time. If you do not want to receive notifications from this study, do not press the Accept button. To ensure others do not see these alerts, make sure your phone, computer, and email accounts are protected by a password, PIN, or other access control. Avoid sharing your account credentials with others.

Who will have access to your data? Efforia will have access to your data. There may also be partners who have access to some of your data as needed to operate the study, such as technology vendors, shipping partners, and service providers involved in study operations.

What will we do with your data: We will use the data to show you your own personal results and to pool your results with those of other participants to provide general outcomes. We will not use your information connected with your name or anything that directly connects the data with you for public reporting without your permission.

If you are a California participant, California law recognizes important rights for people asked to take part in medical experiments. These rights include the right to understand the nature and purpose of the study, the procedures and devices involved, expected discomforts and risks, possible benefits, alternatives, available medical treatment if complications arise, the opportunity to ask questions, the right to withdraw without prejudice, the right to receive a signed and dated copy of the consent form, and the right to make a decision free from force, fraud, deceit, duress, coercion, or undue influence. You may review Efforia’s privacy policy here: https://efforia.com/privacy-policy/.

This study has been reviewed by the Efforia Institutional Review Board (IRB), a group of independent experts who help protect the rights, safety, and well-being of research participants.
If you have questions about your rights as a participant, or would like to speak with someone outside the research team, you can contact the IRB at ethics@efforia.com.

Efforia and the Efforia IRB have approved the information in this consent form and have given approval to publish this study. This does not mean Efforia or the Efforia IRB have approved your being in the study. You must consider the information in this consent form for yourself and decide if you want to be in this study.

If you have questions, please contact help@efforia.com. It is up to you to do additional research and talk to your physician before joining a study.

Efforia has approved the information in this consent form and has given approval to publish this study. This does not mean Efforia has approved or endorses you being in the study. You must consider the information in this consent form and do additional research based on your own situation for yourself and decide if you want to and are appropriate for this study.

If you have questions, please contact help@efforia.com. It is up to you to do additional research and talk to your physician before joining a study.