Sleep More, Stress Less: 90-Day Trial of Neuralli Mood
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Neuralli Mood.
- Who it may be relevant to
- Registry conditions: Psychological Stress, Sleep Disturbance, Anxiety Symptoms, Depressive Symptoms. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
Effects of Neuralli Mood Probiotic Supplementation on Stress, Sleep Disturbance, Mood, and Burnout: A 90-Day Single-Arm Study
Overview
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.
Interventions
- Dietary supplement 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.
Primary outcome measures
- 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 in PROMIS Sleep Disturbance Score [Time frame: Baseline before the first dose and end of the 90-day supplementation period]
Secondary outcome measures (5)
- 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]
Eligibility criteria
Inclusion criteria
- 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.
Exclusion criteria
- 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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: Yes
Study design
- Allocation
- N/A
- Model
- Single group
- Masking
- Open label
- Primary purpose
- Other
Study locations
United States · 1 center
- Efforia - Decentralized United States Study — New York
Identifiers
NCT: NCT07717385 · EFF-NM-90D-2026-01