Psychological StressNM90NCT07717385
Sleep More, Stress Less: 90-Day Trial of Neuralli Mood
A study testing Neuralli Mood in people with Psychological Stress and Sleep Disturbance, run by Efforia, Inc at 1 site in United States.
Trial summary
This decentralized, single-arm study evaluates the effects of 90 days of daily Neuralli Mood supplementation on perceived stress, sleep disturbance, mood, anxiety, depressive symptoms, happiness, and occupational burnout in adults experiencing stress or occasional sleep disruption. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Psychological Stress, Sleep Disturbance, Anxiety Symptoms
- What is being tested?
- Neuralli Mood
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteUnited States
- Study dates
- 30 Jun 2026to 28 Sep 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Age 18 years or older and able to provide informed consent.
- Generally healthy adult experiencing stress, occasional sleep disruption, low mood, anxiety symptoms, or work-related burnout.
- Willing and able to take two capsules of Neuralli Mood daily for 90 days.
- Willing and able to complete electronic baseline, follow-up, adherence, and safety assessments.
- Has reliable access to the internet and an email-enabled device.
Who cannot join
- Pregnant or nursing.
- Known allergy or hypersensitivity to Neuralli Mood, probiotics, or any product ingredient.
- Severe or unstable gastrointestinal disease, including a condition for which probiotic use may be inappropriate.
- Immunocompromised status or current immunosuppressive therapy.
- Severe or unstable mood disorder, acute psychiatric symptoms, or a current risk of harm to self or others.
- A clinically significant sleep disorder for which participation or changes in symptoms should be managed by a healthcare professional.
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- Cognitive impairment or another condition that prevents informed consent or reliable completion of study procedures.
- History of a severe allergic reaction when the investigator determines probiotic use may present an unacceptable risk.
- Use of a medication or presence of a medical condition for which a healthcare professional advises against probiotic supplementation.
- Any other circumstance that, in the investigator's judgment, makes participation inappropriate or unsafe.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Efforia - Decentralized United States Study
New York, New York, 10003
Matthew Amsden, help@efforia.com
Matthew Amsden
About this study
Official title: Effects of Neuralli Mood Probiotic Supplementation on Stress, Sleep Disturbance, Mood, and Burnout: A 90-Day Single-Arm Study
This decentralized, single-arm study evaluates the effects of 90 days of daily Neuralli Mood supplementation on perceived stress, sleep disturbance, mood, anxiety, depressive symptoms, happiness, and occupational burnout in adults experiencing stress or occasional sleep disruption. Participants serve as their own controls, completing validated self-report measures before beginning supplementation and again after the 90-day intervention, with safety and adherence check-ins during the study.
Read the detailed description
Neuralli Mood is a probiotic and postbiotic dietary supplement containing the proprietary gut-brain strains L. plantarum PS128 and heat-treated L. paracasei PS23. Participants take two capsules once daily, with or without food, at a consistent time for 90 days. Each two-capsule daily dose contains 30 billion CFU of L. plantarum PS128 and 20 billion heat-treated cells of L. paracasei PS23.
The study uses a prospective, open-label, single-group, within-participant design. Participants complete baseline assessments before the first dose and repeat the primary and secondary outcome assessments at the end of the 90-day supplementation period. Scheduled check-ins are used to assess adherence, tolerability, and adverse events.
The study is exploratory and is intended to generate preliminary evidence and individualized before-and-after information. Results will be interpreted in light of the absence of a concurrent control group, participant self-selection, expectation effects, and reliance on self-reported outcomes.
- Conditions
- Psychological Stress, Sleep Disturbance, Anxiety Symptoms, Depressive Symptoms, Occupational Burnout
- Being tested
- Neuralli Mood
- Keywords
- Neuralli Mood, Probiotic, Postbiotic, Psychobiotic, Gut-brain axis, Lactiplantibacillus plantarum PS128, Lacticaseibacillus paracasei PS23, Stress, Sleep, Burnout, Citizen science
- Medical subject headings
- Stress, Psychological, Parasomnias, Anxiety Disorders, Depression, Burnout, Professional, Burnout, Psychological
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Neuralli MoodDietary supplement
Also called Bened Life Neuralli Mood
Two acid-resistant capsules taken once daily for 90 days. Each daily dose contains 30 billion CFU of L. plantarum PS128 and 20 billion heat-treated cells of L. paracasei PS23. Other ingredients include microcrystalline cellulose, hypromellose, pectin, glycerol, silica, and magnesium stearate.
| Study group | Role | What they receive |
|---|---|---|
| Neuralli Mood Supplementation | Experimental | Participants take two capsules of Neuralli Mood once daily, with or without food, at a consistent time for 90 days and complete scheduled study assessments and safety check-ins. Receives: Dietary Supplement: Neuralli Mood |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Depression Anxiety and Stress Scales-21 Stress Subscale Score
Change from baseline in the Stress subscale score of the Depression Anxiety and Stress Scales-21. Higher scores (maximum score of 42) represent greater severity of stress symptoms. (Minimum score of 0).
Measured: Baseline before the first dose and end of the 90-day supplementation period
Change in PROMIS Sleep Disturbance Score
Change from baseline in the PROMIS Sleep Disturbance score. Higher scores (Maximum 40) represent greater sleep disturbance. Lower (Minimum 8) represent lower sleep disturbance.
Measured: Baseline before the first dose and end of the 90-day supplementation period
Secondary outcomes (5)
Change in Depression Anxiety and Stress Scales-21 Anxiety Subscale Score
Change from baseline in the Anxiety subscale score of the Depression Anxiety and Stress Scales-21. Higher scores represent greater severity of anxiety symptoms. (minimum 0 to maximum 21)
Measured: Baseline before the first dose and end of the 90-day supplementation period
Change in Depression Anxiety and Stress Scales-21 Depression Subscale Score
Change from baseline in the Depression subscale score of the Depression Anxiety and Stress Scales-21. Higher scores represent greater severity of depressive symptoms. (Minumum 0, maximum 21)
Measured: Baseline before the first dose and end of the 90-day supplementation period
Change in Oxford Happiness Questionnaire Score
Change from baseline in the Oxford Happiness Questionnaire total score. Higher raw scores (max 174) represent greater self-reported happiness versus low scores (min 29).
Measured: Baseline before the first dose and end of the 90-day supplementation period
Change in Burnout Assessment Survey Score
Change from baseline in the total score from the study's Burnout Assessment Survey, interpreted according to the instrument's scoring procedures. Raw Sum Minimum Score: 23 (Patient responds "Never" to every single item)Raw Sum Maximum Score: 115 (Patient responds "Always" to every single item)
Measured: Baseline before the first dose and end of the 90-day supplementation period
Number of Participants With Treatment-Emergent Adverse Events
Number and proportion of participants reporting adverse events during supplementation, including gastrointestinal symptoms, allergic reactions, mood changes, sleep-related symptoms, discontinuations, and events requiring medical attention.
Measured: From the first dose through completion of the 90-day supplementation period
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Jul 2026
- Study start30 Jun 2026
- Primary completion28 Sep 2027 (estimated)
- Study completion28 Sep 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Psychological StressStudies of the same condition, open and under way.
- More trials run by Efforia, IncThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- All participants complete baseline assessments, take two capsules of Neuralli Mood daily for 90 days, complete scheduled adherence and safety check-ins, and repeat the outcome assessments at the end of the supplementation period. Each participant serves as his or her own control.
- Masking
- None (open label)
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Efforia, Inc
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Bened Life
- Responsible party
- Sponsor
- Investigators
- Matthew Amsden, Principal investigator, Efforia, Inc
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07717385
- Sponsor's protocol ID
- EFF-NM-90D-2026-01
- Acronym
- NM90
- Status last verified
- Jul 2026
- First submitted
- 13 Jul 2026
- Last updated
- 21 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: No individual participant data sharing plan has been finalized.
Study at a glance
From the registry record, last updated by the sponsor on 21 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Neuralli Mood Probiotic Supplementation on Stress, Sleep Disturbance, Mood, and Burnout: A 90-Day Single-Arm Study
- ClinicalTrials.gov ID
- NCT07717385
- Acronym / sponsor ID
- NM90 / EFF-NM-90D-2026-01
- Conditions
- Psychological Stress, Sleep Disturbance, Anxiety Symptoms, Depressive Symptoms, Occupational Burnout
- Keywords
- Neuralli Mood, Probiotic, Postbiotic, Psychobiotic, Gut-brain axis, Lactiplantibacillus plantarum PS128, Lacticaseibacillus paracasei PS23, Stress
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Efforia, IncIndustry (pharma, biotech, devices)
- Collaborators
- Bened Life
- Study start
- 30 Jun 2026 (actual)
- Primary completion
- 28 Sep 2027 (estimated)
- Study completion
- 28 Sep 2027 (estimated)
- First posted
- 21 Jul 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This decentralized, single-arm study evaluates the effects of 90 days of daily Neuralli Mood supplementation on perceived stress, sleep disturbance, mood, anxiety, depressive symptoms, happiness, and occupational burnout in adults experiencing stress or occasional sleep disruption. Participants serve as their own controls, completing validated self-report measures before beginning supplementation and again after the 90-day intervention, with safety and adherence check-ins during the study.
Detailed description
Neuralli Mood is a probiotic and postbiotic dietary supplement containing the proprietary gut-brain strains L. plantarum PS128 and heat-treated L. paracasei PS23. Participants take two capsules once daily, with or without food, at a consistent time for 90 days. Each two-capsule daily dose contains 30 billion CFU of L. plantarum PS128 and 20 billion heat-treated cells of L. paracasei PS23.
The study uses a prospective, open-label, single-group, within-participant design. Participants complete baseline assessments before the first dose and repeat the primary and secondary outcome assessments at the end of the 90-day supplementation period. Scheduled check-ins are used to assess adherence, tolerability, and adverse events.
The study is exploratory and is intended to generate preliminary evidence and individualized before-and-after information. Results will be interpreted in light of the absence of a concurrent control group, participant self-selection, expectation effects, and reliance on self-reported outcomes.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- All participants complete baseline assessments, take two capsules of Neuralli Mood daily for 90 days, complete scheduled adherence and safety check-ins, and repeat the outcome assessments at the end of the supplementation period. Each participant serves as his or her own control.
| Arm | Type | Receives |
|---|---|---|
| Neuralli Mood Supplementation | Experimental | Dietary Supplement: Neuralli MoodParticipants take two capsules of Neuralli Mood once daily, with or without food, at a consistent time for 90 days and complete scheduled study assessments and safety check-ins. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Age 18 years or older and able to provide informed consent.
- Generally healthy adult experiencing stress, occasional sleep disruption, low mood, anxiety symptoms, or work-related burnout.
- Willing and able to take two capsules of Neuralli Mood daily for 90 days.
- Willing and able to complete electronic baseline, follow-up, adherence, and safety assessments.
- Has reliable access to the internet and an email-enabled device.
Key exclusion criteria (10 listed)
- Pregnant or nursing.
- Known allergy or hypersensitivity to Neuralli Mood, probiotics, or any product ingredient.
- Severe or unstable gastrointestinal disease, including a condition for which probiotic use may be inappropriate.
- Immunocompromised status or current immunosuppressive therapy.
- Severe or unstable mood disorder, acute psychiatric symptoms, or a current risk of harm to self or others.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Neuralli MoodAlso: Bened Life Neuralli MoodTwo acid-resistant capsules taken once daily for 90 days. Each daily dose contains 30 billion CFU of L. plantarum PS128 and 20 billion heat-treated cells of L. paracasei PS23. Other ingredients include microcrystalline cellulose, hypromellose, pectin, glycerol, silica, and magnesium stearate. | Dietary supplement | Neuralli Mood Supplementation |
Primary outcome
Change in Depression Anxiety and Stress Scales-21 Stress Subscale Score
Time frame: Baseline before the first dose and end of the 90-day supplementation period
Change from baseline in the Stress subscale score of the Depression Anxiety and Stress Scales-21. Higher scores (maximum score of 42) represent greater severity of stress symptoms. (Minimum score of 0).
Change in PROMIS Sleep Disturbance Score
Time frame: Baseline before the first dose and end of the 90-day supplementation period
Change from baseline in the PROMIS Sleep Disturbance score. Higher scores (Maximum 40) represent greater sleep disturbance. Lower (Minimum 8) represent lower sleep disturbance.
5 secondary outcomes
Change in Depression Anxiety and Stress Scales-21 Anxiety Subscale Score
Time frame: Baseline before the first dose and end of the 90-day supplementation period
Change in Depression Anxiety and Stress Scales-21 Depression Subscale Score
Time frame: Baseline before the first dose and end of the 90-day supplementation period
Change in Oxford Happiness Questionnaire Score
Time frame: Baseline before the first dose and end of the 90-day supplementation period
Change in Burnout Assessment Survey Score
Time frame: Baseline before the first dose and end of the 90-day supplementation period
Number of Participants With Treatment-Emergent Adverse Events
Time frame: From the first dose through completion of the 90-day supplementation period
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Jul 2026.
- Individual participant dataSharing planned: Undecided. No individual participant data sharing plan has been finalized.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Matthew Amsden principal investigator
Efforia, Inc
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Neuralli Mood in people with Psychological Stress and Sleep Disturbance, run by Efforia, Inc at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 21 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Matthew Amsden (+13232844626, help@efforia.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Depression Anxiety and Stress Scales-21 Stress Subscale Score (time frame: Baseline before the first dose and end of the 90-day supplementation period). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Jul 2026.