Recruiting

Neuralli Mood

Sponsor:

Efforia, Inc

Code:

NCT07717385

Conditions

Psychological Stress

Sleep Disturbance

Anxiety Symptoms

Depressive Symptoms

Occupational Burnout

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Accepted

Interventions

Neuralli Mood

Study Details

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.

Conditions

Psychological Stress

Sleep Disturbance

Anxiety Symptoms

Depressive Symptoms

Occupational Burnout

Study ID

NCT07717385

Start date

Jun 30, 2026

Status verified date

Jul, 2026

Completion date

Sep 28, 2027

Anticipated

Primary completion date

Sep 28, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Accepted

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.

Study Design

Enrollment

100 participants

Anticipated

Intervention Model

Single group

Primary purpose

Other

Interventions and Outcome Measures

Arms

experimental: Neuralli Mood Supplementation

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.

Interventions

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 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 ]
  • Change in PROMIS Sleep Disturbance Score [ Time Frame: Baseline before the first dose and end of the 90-day supplementation period ]

Central Contacts and Locations

Central contacts

Locations

Efforia - Decentralized United States Study

Recruiting

New York, New York, United States, 10003

Contacts

Matthew Amsden

help@efforia.com

Principal Investigator:

Matthew Amsden

More Information

Sponsor

Efforia, Inc

Last update posted

Jul 21, 2026

Last verified

Jul, 2026

Keywords

  • Neuralli Mood
  • Probiotic
  • Postbiotic
  • Psychobiotic
  • Gut-brain axis
  • Lactiplantibacillus plantarum PS128
  • Lacticaseibacillus paracasei PS23
  • Stress
  • Sleep
  • Burnout
  • Citizen science

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Efforia, Inc on 2026-07-21.