CompletedNot Applicable

Pilot Study to Assess the Effect of a Probiotic Blend on Moderate Self-reported Anxiety.

Ireland100 participantsStarted 2022-12-20

Plain-language 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

Who can participate

Age range18 Years – 65 Years

SexALL

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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 ≤25.
✓. Have a Beck Depression Inventory (BDI) score \<25.
✓. 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.

Exclusion criteria

✕. Are less than 18 or greater than 65.
✕. 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.

What they're measuring

Change in Anxiety rating

Timeframe: Day 0, Day 42, Day 84.

Trial details

NCT IDNCT05562752

SponsorThe Archer-Daniels-Midland Company

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2023-08-15

View on ClinicalTrials.gov More Anxiety trials