Sleep More, Stress Less: 90-Day Trial of Neuralli Mood
NM90
Effects of Neuralli Mood Probiotic Supplementation on Stress, Sleep Disturbance, Mood, and Burnout: A 90-Day Single-Arm Study
1 other identifier
interventional
100
1 country
1
Brief 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. 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Jun 2026
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
June 30, 2026
CompletedFirst Submitted
Initial submission to the registry
July 13, 2026
CompletedFirst Posted
Study publicly available on registry
July 21, 2026
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 28, 2027
ExpectedStudy Completion
Last participant's last visit for all outcomes
September 28, 2027
July 21, 2026
July 1, 2026
1.2 years
July 13, 2026
July 16, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
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).
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.
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
Baseline before the first dose and end of the 90-day supplementation period
Change in Depression Anxiety and Stress Scales-21 Depression Subscale Score
Baseline before the first dose and end of the 90-day supplementation period
Change in Oxford Happiness Questionnaire Score
Baseline before the first dose and end of the 90-day supplementation period
Change in Burnout Assessment Survey Score
Baseline before the first dose and end of the 90-day supplementation period
Number of Participants With Treatment-Emergent Adverse Events
From the first dose through completion of the 90-day supplementation period
Study Arms (1)
Neuralli Mood Supplementation
EXPERIMENTALParticipants 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.
Interventions
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.
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Efforia, Inclead
- Bened Lifecollaborator
Study Sites (1)
Efforia - Decentralized United States Study
New York, New York, 10003, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Matthew Amsden
Efforia, Inc
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Masking Details
- Participants and investigators know that Neuralli Mood is being administered. No placebo or blinded comparator is used.
- Purpose
- OTHER
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
July 13, 2026
First Posted
July 21, 2026
Study Start
June 30, 2026
Primary Completion (Estimated)
September 28, 2027
Study Completion (Estimated)
September 28, 2027
Last Updated
July 21, 2026
Record last verified: 2026-07