NCT05562752
Completed
Not Applicable
A Randomized, Double-blinded, Placebo-controlled, Parallel Pilot Study, to Assess the Effect of a Probiotic Blend on Symptoms of Anxiety in Healthy Adults with Self-reported Mild to Moderate Anxiety
The Archer-Daniels-Midland Company1 site in 1 country100 target enrollmentDecember 20, 2022
ConditionsAnxiety
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Anxiety
- Sponsor
- The Archer-Daniels-Midland Company
- Enrollment
- 100
- Locations
- 1
- Primary Endpoint
- Change in Anxiety rating
- Status
- Completed
- Last Updated
- last year
Overview
Brief Summary
This study evaluates the efficacy of a multistrain probiotic administered in the form of a capsule in the management of moderate self-reported anxiety in adults aged 18-65
Investigators
Eligibility Criteria
Inclusion Criteria
- •Be able to give written informed consent.
- •Be between 18 to 65 years inclusive.
- •Mild to moderate self-reported anxiety, defined as a Beck Anxiety Inventory (BAI) score ≥8 and ≤
- •Have a Beck Depression Inventory (BDI) score \<
- •Is in general good health, as determined by the investigator.
- •Be willing to maintain stable dietary habits and physical activity levels throughout the study period.
- •Be able to communicate well with the Investigator, to understand and comply with the requirements of the study and be judged suitable for the study in the opinion of the Investigator.
- •Willing to consume the study product daily for the duration of the trial and comply with all trial procedures.
- •Part 2 Inclusion Criteria (see separate trial):
- •Be able to give confirmation of ongoing informed consent
Exclusion Criteria
- •Are less than 18 or greater than
- •Participants who are pregnant or wish to become pregnant during the trial.
- •Participants who are lactating and/or currently breastfeeding
- •Participants currently of childbearing potential, but not using an effective method of contraception, as outlined below:
- •Complete abstinence from intercourse two weeks prior to administration of the study product, throughout the clinical trial, until the completion of follow-up procedures or for two weeks following discontinuation of the study product in cases where Participant discontinues the trial prematurely. (Participants utilising this method must agree to use an alternate method of contraception if they should become sexually active and will be queried on whether they have been abstinent in the preceding 2 weeks when they present to the clinic for the Final Visit).
- •Has a male sexual partner who is surgically sterilised prior to the Screening Visit and is the only male sexual partner for that Participant.
- •Sexual partner(s) is/are exclusively female.
- •Use of acceptable method of contraception, such as a spermicide, mechanical barrier (e.g. male condom, female diaphragm), tubal ligation or contraceptive pill. The Participant must be using this method for at least 1 week prior to and 1 week following the end of the trial.
- •Use of any intrauterine device (IUD) or contraceptive implant. The Participant must have the device inserted at least 2 weeks prior to the first Screening Visit, throughout the trial, and 2 weeks following the end of the trial.
- •Are hypersensitive to any of the components of the study product.
Outcomes
Primary Outcomes
Change in Anxiety rating
Time Frame: Day 0, Day 42, Day 84.
Level of anxiety measured with "Hamilton Anxiety Rating Scale". (max 56 points) where a lower score means better outcomes compared to baseline.
Secondary Outcomes
- Change in Depression score(Day 0, Day 28, Day 42, Day 84.)
- Change in trait anxiety(Day 0, Day 28, Day 42, Day 84.)
- Change in perceived stress(Day 0, Day 28, Day 42, Day 84.)
- Change in Stress(Day 0, Day 42, Day 84.)
- Change in Sleep Quality(Day 0, Day 28, Day 42, Day 84.)
- Change in Gastrotintestinal symptoms(Day 0, Day 28, Day 42, Day 84.)
- Change in Quality of Life evaluation(Day 0, Day 28, Day 42, Day 84.)
Study Sites (1)
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