Effects of a Probiotic on Aspects of Mental Wellness

A Randomized, Double-Blind, Placebo-Controlled Parallel Study to Examine the Effects of a Probiotic on Aspects of Mental Wellness

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.

Study Overview

• Status: Completed
• Conditions: Mental Health Wellness
• Intervention / Treatment: Dietary supplement: Dietary Supplement: Probiotics; Dietary supplement: Dietary Supplement: Placebo

• Study Type: Interventional
• Enrollment (Actual): 120
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Maher Fuad, MBChB, MPH, PhD; Phone Number: 006463517750; Email: maher.fuad@fonterra.com

Study Locations

• United States
  • Illinois
    • Addison, Illinois, United States, 60101
      • Biofortis

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Placebo	Dietary supplement: Dietary Supplement: Placebo; 0 CFU per day
Experimental: Probiotic Arm	Dietary supplement: Dietary Supplement: Probiotics; 6 Billion CFU

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in Mental wellbeing	Improvement in mental wellbeing will be measured using the Oxford Happiness Questionnaire (OHQ). The Oxford Happiness Inventory was devised as a broad measure of personal happiness. The OHQ has a total of 29 items. Each item is scored on a Likert scale from 1 to 6 (1=strongly disagree; 2=moderately disagree; 3=slightly disagree; 4=slightly agree; 5=moderately agree; 6=strongly agree). Some items are phrased positively and others negatively. Such that negative items (1, 3, 12, 13, 16, 18, 21 and 29) should be scored in reverse (Hills & Argyle, 2002). The total score is then divided by 29. Interpretation of the final score is as follows: A final score between 1 to 2 is considered "not happy"; between 2 and 3 is "somewhat unhappy"; between 3 and 4 is considered "Neutral"; 4 is "somewhat or moderately happy"; between 4 and 5 is "rather happy"; between 5 and 6 is "very happy"; 6 is "too happy".	4 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in Stress scores	Change in stress scores will be measured using the short version of the Depression, Anxiety, Stress Scale (DASS-21). Each item is scored from 0 to 3, with a score of 0 indicating that the statement did not apply or never. A score of 3 indicates that the statement applied very much or almost always. In DASS-21, items 1, 6, 8, 11, 12, 14 and 18 relate to measurement of stress. Given that DASS-21 is the short version of DASS-42, the total item score is multiplied by 2. The final total scores range from 0 (no stress) to 42 (extremely stressed). Scores ranging between 0-14 (stress) are considered normal. Scores above 14 are considered positive for stress.	4 weeks
Change in anxiety scores	Change in anxiety scores will be measured using the short version of the Depression, Anxiety, Stress Scale (DASS-21). Each item is scored from 0 to 3, with a score of 0 indicating that the statement did not apply or never. A score of 3 indicates that the statement applied very much or almost always. In DASS-21, items 2, 4, 7, 9, 15, 19 and 20 relate to measurement of anxiety. Given that DASS-21 is the short version of DASS-42, the total item score is multiplied by 2. The final total scores range from 0 (no anxiety) to 42 (extremely anxious). Scores ranging between 0-14 (stress) are considered normal. Scores above 14 are considered positive for anxiety.	4 weeks
Change in Depression scores	Change in depression scores will be measured using the short version of the Depression, Anxiety, Stress Scale (DASS-21). Each item is scored from 0 to 3, with a score of 0 indicating that the statement did not apply or never. A score of 3 indicates that the statement applied very much or almost always. In DASS-21, items 3, 5, 10, 13, 16, 17, and 21 relate to measurement of depression . Given that DASS-21 is the short version of DASS-42, the total item score is multiplied by 2. The final total scores range from 0 (no depression ) to 42 (extremely depressed). Scores ranging between 0-14 (stress) are considered normal. Scores above 14 are considered positive for depression .	4weeks
Change in Stress Scores	In addition o the DASS, Subjects will complete the Perceived Stress Scale during screening for eligibility purposes and on Days 13 and 27 for outcome assessments. The Perceived Stress Scale is a retrospective 10-item questionnaire asking about feelings and thoughts "over the last month" . Scores are obtained by reversing responses (e.g., 0 = 4, 1 = 3, 2 = 2, 3 = 1 & 4 = 0) to the four positively stated items (items 4, 5, 7, & 8) and then summing across all scale items. Eligible participants will be required to have a total score ≥14, indicating moderate (score 14-26) or high (27-40) perceived stress.	4 weeks

Collaborators and Investigators

• Sponsor: Fonterra Research Centre
• Investigators: Principal Investigator: Dawn B Beckman,, MD, Biofortis Innovation Services

Study record dates

Study Major Dates

• Study Start (Actual): July 20, 2023
• Primary Completion (Actual): September 12, 2023
• Study Completion (Actual): September 12, 2023

Study Registration Dates

• First Submitted: June 7, 2023
• First Submitted That Met QC Criteria: June 7, 2023
• First Posted (Actual): June 15, 2023

Study Record Updates

• Last Update Posted (Actual): October 23, 2023
• Last Update Submitted That Met QC Criteria: October 18, 2023
• Last Verified: June 1, 2023

More Information

Terms related to this study

• Other Study ID Numbers: BIO-2306

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No