Clinical trial NCT05905679: Effects of a Probiotic on Aspects of Mental Wellness
Official title: A Randomized, Double-Blind, Placebo-Controlled Parallel Study to Examine the Effects of a Probiotic on Aspects of Mental Wellness
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Mental Health Wellness
Lead sponsor: Fonterra Research Centre
Sponsor class: INDUSTRY
First posted: 2023-06-15
Enrollment: 120
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief summary: The goal of this clinical trial is to compare the effect of a probiotic strain on mental wellbeing in moderately stressed, healthy, adults in the general population. The main question it aims to answer is

• what is the impact of probiotic consumption on overall mental wellbeing? Participants will consume one probiotic or placebo capsule per day, answer a set of questionnaire (at 3 time points) and wear a wearable device for the total duration of the study.


Eligibility criteria: Inclusion Criteria:

1. Age ≥18 years at screening.
2. Score of ≥14 on the Perceived Stress Scale questionnaire.
3. Has access to a dedicated iPhone with iOS 12+ or an Android 8+ capable of downloading and running the study specific app.
4. Willing to maintain habitual diet and lifestyle, physical activity patterns, and body weight during the study period.
5. Willing to refrain from exclusionary medications, supplements, and products throughout the study.
6. Has no plan to change nicotine habits during the study period.
7. Has no health conditions that would prevent her from fulfilling the study requirements as judged by the Clinical Investigator on the basis of medical history.
8. Understands the study procedures and signs forms providing informed consent to participate in the study and authorizes the release of relevant protected health information to the Clinical Investigator.

Exclusion Criteria:

1. Daily consumption of prebiotic, postbiotic, or probiotic supplements as well as foods/beverages fortified to contain live probiotics (e.g., kombucha) within 2 weeks of screening.
2. Clinically diagnosed neurologic or psychiatric disorders (e.g., bipolar disorder, clinical depression, post-partum depression) currently requiring medication, such as antipsychotics, anticonvulsants, and antiparkinsonian agents as well as medications for bipolar disorder.
3. Current use of prescription stimulant medications \[e.g., amphetamines/dextroamphetamine (Adderall), methylphenidate (Ritalin, Concerta), methamphetamine (Desoxyn), dextroamphetamine (Dexedrine), lisdexamfetamine (Vyvanse)\].
4. Current use of antibiotics.
5. Clinically diagnosed GI condition that would potentially interfere with the evaluation of the study product (e.g., inflammatory bowel disease, irritable bowel syndrome, Crohn's disease, celiac disease).
6. Use of cannabis, marijuana or cannabinoid products, including those that are consumed, orally inhaled, smoked, applied topically, etc. within 6 months of screening.
7. Contraindication or allergy/sensitivity to any components in the study product or allergens present in the facility used to manufacture or pack the study product (Appendix 7).
8. Elective hospitalizations planned (e.g., elective cosmetic procedures) during the study period.
9. Exposure to any non-registered drug product within 4 weeks of screening.
10. Female who is pregnant, planning to be pregnant during the study period, lactating, or is of childbearing potential and is unwilling to commit to the use of a medically approved form of contraception throughout the study period.
11. Recent history of (within 12 months of screening) or strong potential for alcohol or substance abuse. Alcohol abuse is defined as \>14 drinks per week (1 drink = 12 oz beer, 5 oz wine, or 1½ oz distilled spirits).
12. Has a condition the Clinical Investigator believes would interfere with the subject's ability to provide informed consent, comply with the study protocol, confound the interpretation of the study results, or put the subject at undue risk.

Primary outcomes:
measure: Change in Mental wellbeing
timeFrame: 4 weeks
Secondary outcomes:
measure: Change in Stress scores
timeFrame: 4 weeks
measure: Change in anxiety scores
timeFrame: 4 weeks
measure: Change in Depression scores
timeFrame: 4weeks
measure: Change in Stress Scores
timeFrame: 4 weeks
Other outcomes:
Locations:
city: Addison
country: United States
facility: Biofortis
state: Illinois
Study officials:
affiliation: Biofortis Innovation Services
name: Dawn B Beckman,, MD
role: PRINCIPAL_INVESTIGATOR
References: