Effects of a Probiotic on Aspects of Mental Wellness

NCT05905679 | Completed

• 1 other identifier: BIO-2306
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (4)

• Change in Stress scores

  4 weeks

• Change in anxiety scores

  4 weeks

• Change in Depression scores

  4weeks

• Change in Stress Scores

  4 weeks

Study Arms (2)

Probiotic Arm

EXPERIMENTAL

Dietary Supplement: Dietary Supplement: Probiotics

Placebo

ACTIVE COMPARATOR

Dietary Supplement: Dietary Supplement: Placebo

Interventions

Dietary Supplement: Probiotics DIETARY_SUPPLEMENT

6 Billion CFU

Probiotic Arm

Dietary Supplement: Placebo DIETARY_SUPPLEMENT

0 CFU per day

Placebo

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age ≥18 years at screening.
• Score of ≥14 on the Perceived Stress Scale questionnaire.
• Has access to a dedicated iPhone with iOS 12+ or an Android 8+ capable of downloading and running the study specific app.
• Willing to maintain habitual diet and lifestyle, physical activity patterns, and body weight during the study period.
• Has no plan to change nicotine habits during the study period.
• 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.
• 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.

You may not qualify if:

• 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.
• 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.
• Current use of prescription stimulant medications \[e.g., amphetamines/dextroamphetamine (Adderall), methylphenidate (Ritalin, Concerta), methamphetamine (Desoxyn), dextroamphetamine (Dexedrine), lisdexamfetamine (Vyvanse)\].
• Current use of antibiotics.
• 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).
• Use of cannabis, marijuana or cannabinoid products, including those that are consumed, orally inhaled, smoked, applied topically, etc. within 6 months of screening.
• 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).
• Elective hospitalizations planned (e.g., elective cosmetic procedures) during the study period.
• Exposure to any non-registered drug product within 4 weeks of screening.
• 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.
• 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).
• 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.

Sponsors & Collaborators

• Fonterra Research Centre: lead

Study Sites (1)

Biofortis

Addison, Illinois, 60101, United States

Location

Study Officials

• Dawn B Beckman,, MD

  Biofortis Innovation Services

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 7, 2023
• First Posted: June 15, 2023
• Study Start: July 20, 2023
• Primary Completion: September 12, 2023
• Study Completion: September 12, 2023
• Last Updated: October 23, 2023

Record last verified: 2023-06

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)