Effects of a Probiotic on Aspects of Mental Wellness

NCT ID: NCT05905679

Last Updated: 2023-10-23

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 120 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-07-20
• Study Completion Date: 2023-09-12

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.

Conditions

Mental Health Wellness

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: OTHER
• Blinding Strategy: TRIPLE

Study Groups

Probiotic Arm

Group Type: EXPERIMENTAL

Dietary Supplement: Probiotics

Intervention Type: DIETARY_SUPPLEMENT

6 Billion CFU

Placebo

Group Type: ACTIVE_COMPARATOR

Dietary Supplement: Placebo

Intervention Type: DIETARY_SUPPLEMENT

0 CFU per day

Interventions

Dietary Supplement: Probiotics

6 Billion CFU

Intervention Type: DIETARY_SUPPLEMENT

Dietary Supplement: Placebo

0 CFU per day

Intervention Type: DIETARY_SUPPLEMENT

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Fonterra Research Centre

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Dawn B Beckman,, MD

Role: PRINCIPAL_INVESTIGATOR

Biofortis Innovation Services

Locations

Biofortis

Addison, Illinois, United States

Countries

United States

Other Identifiers

BIO-2306

Identifier Type: -

Identifier Source: org_study_id