Pilot Study to Assess the Effect of a Probiotic Blend on Moderate Self-reported Anxiety. (NCT05562752) | Clinical Trial Compass
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 range
18 Years – 65 Years
Sex
ALL
See this in plain English?
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.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
. 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.