AnxietyAnxNCT05562752
Pilot Study to Assess the Effect of a Probiotic Blend on Moderate Self-reported Anxiety.
A study testing Probiotic in people with Anxiety, run by The Archer-Daniels-Midland Company at 1 site in Ireland.
Trial 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 Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Anxiety
- What is being tested?
- Probiotic
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 100 participants
- Where
- 1 siteIreland
- Study dates
- 20 Dec 2022to 15 Aug 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
None listed.
Who cannot join
- 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.
Show all 28Show fewer
- 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.
- Has taken systemic antibiotics within the previous 8 weeks.
- Has taken probiotics or post-biotics within the previous 8 weeks.
- Has a current clinical diagnosis of depression - determined in their medical history.
- Has self-reported or suspected consumption of excess quantities of alcohol or recreational drugs
- Diagnosed with significant physical comorbidity that, in the investigator's judgment, precludes involvement in the study.
- Has an acute or chronic illness (e.g., heart disease, inflammatory bowel disease, cancer, HIV) that, in the Investigators judgment, precludes involvement in the study.
- Participants who have received cognitive behavioural therapy (CBT) or psychotherapy in the 8 weeks prior to baseline or plan to start during the period of the study.
- Participants who have taken anti-depressants or supplements known to impact mood (e.g., valerian, St. John's Wort) in the 8 weeks prior to baseline or planning to start in the study period.
- Taking dietary supplements or food products that the investigator believes would interfere with the objectives of the study within 8 weeks prior to baseline ;
- Participants who have taken psychotropics, anxiolytics, antipsychotics, anticonvulsants, systemic corticosteroids, opioid pain relievers, hypnotics, and/or prescribed sleep medication within 8-weeks of screening.
- Has a gastrointestinal disease or condition, that by the investigators judgement, could interfere with the intestinal barrier function.
- Are severely immunocompromised (transplant patient, on antirejection medications, on a steroid for 30 days, or chemotherapy or radiotherapy within the last year; HIV positive participants with undetectable viral loads would be allowed on the trial)
- Have an active malignant disease or any concomitant end-stage organ disease (in the last 12 months), which, in the Investigator's judgment, contraindicates participation in the study.
- Any immunosuppressant or chemotherapy medications, including mercaptopurine, azathioprine, or methotrexate;
- Have had any other condition or are taking a medication that the investigator believes would interfere with the objectives of the study, pose a safety risk, or confound the interpretation of the study results
- Individuals who, in the opinion of the investigator, are considered to be poor attendees or unlikely for any reason to be able to comply with the trial.
- Participants may not be receiving treatment involving experimental drugs. If the Participant has been in a recent experimental trial, these must have been completed not less than 8 weeks prior to this trial.
- Any Participant who is an employee of the study site or an Atlantia Clinical Trials employee or their close family member or a member of their household.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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
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
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ProbioticDietary supplement
multistrain probiotic in the form of a capsule with a daily dose of 1E+9 Colony Forming Unit (CFU) per day for 12 weeks.
PlaceboDietary supplement
Matching placebo in a form of a capsule for 12 weeks.
| Study group | Role | What they receive |
|---|---|---|
| Active | Experimental | Arm receiving investigational product (probiotic) Receives: Dietary Supplement: Probiotic |
| Placebo | Placebo comparator | Arm receiving placebo Receives: Dietary Supplement: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Anxiety rating
Level of anxiety measured with "Hamilton Anxiety Rating Scale". (max 56 points) where a lower score means better outcomes compared to baseline.
Measured: Day 0, Day 42, Day 84.
Secondary outcomes (8)
Change in Depression score
Level of depression measured with "Beck's Depression Inventory". (max 63 points) where a lower score means better outcomes compared to baseline.
Measured: Day -7, Day 0, Day 28, Day 42, Day 84.
Change in Depression score
Level of depression measured with "Patient Health Questionnaire 9". (max 27 points) where a lower score means better outcomes compared to baseline.
Measured: Day 0, Day 28, Day 42, Day 84.
Change in trait anxiety
Level of trait anxiety measured with "State-Trait Anxiety Inventory" (max 80 points) where a lower score means better outcomes compared to baseline.
Measured: Day 0, Day 28, Day 42, Day 84.
Change in perceived stress
Level of perceived stress measured with "Cohen's perceived Stress scale" (max 40 points ) where a lower score means better outcomes compared to baseline.
Measured: Day 0, Day 28, Day 42, Day 84.
Change in Stress
Level of stress measured with "Salivary Cortisol awakening response" (ng/dL).
Measured: Day 0, Day 42, Day 84.
Change in Sleep Quality
Change in sleep quality measured by "Pittsburgh Sleep Quality Index" (max 21 points) where a lower score means better outcomes compared to baseline.
Measured: Day 0, Day 28, Day 42, Day 84.
Change in Gastrotintestinal symptoms
Degree of GI symptoms measured by "GI Symptom Rating Scale" where a lower score means better outcomes compared to baseline.
Measured: Day 0, Day 28, Day 42, Day 84.
Change in Quality of Life evaluation
Change in quality of life score measured by the "SF-36 questionnaire" (max 100 points) where a higher score means better outcomes compared to baseline.
Measured: Day 0, Day 28, Day 42, Day 84.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Oct 2022
- Study start20 Dec 2022
- Primary completion15 Aug 2023
- Study completion15 Aug 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AnxietyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Study consists of 2 parts with the participants in part 2 being recruited from "Placebo non-responders" in Part 1.
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- The Archer-Daniels-Midland Company
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Atlantia Food Clinical Trials
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05562752
- Sponsor's protocol ID
- CTB2022TN105P1
- Other IDs
- AFCRO-154
- Acronym
- Anx
- Status last verified
- Mar 2024
- First submitted
- 28 Sep 2022
- Last updated
- 22 Jan 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT05562752
- Acronym / sponsor ID
- Anx / CTB2022TN105P1
- Conditions
- Anxiety
- Keywords
- probiotic, microbiome, postbiotic
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- The Archer-Daniels-Midland CompanyIndustry (pharma, biotech, devices)
- Collaborators
- Atlantia Food Clinical Trials
- Study start
- 20 Dec 2022 (actual)
- Primary completion
- 15 Aug 2023 (actual)
- Study completion
- 15 Aug 2023 (actual)
- First posted
- 3 Oct 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- Study consists of 2 parts with the participants in part 2 being recruited from "Placebo non-responders" in Part 1.
| Arm | Type | Receives |
|---|---|---|
| Active | Experimental | Dietary Supplement: ProbioticArm receiving investigational product (probiotic) |
| Placebo | Placebo comparator | Dietary Supplement: PlaceboArm receiving placebo |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (0 listed)
Key exclusion criteria (28 listed)
- 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).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Probioticmultistrain probiotic in the form of a capsule with a daily dose of 1E+9 Colony Forming Unit (CFU) per day for 12 weeks. | Dietary supplement | Active |
| PlaceboMatching placebo in a form of a capsule for 12 weeks. | Dietary supplement | Placebo |
Primary outcome
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.
8 secondary outcomes
Change in Depression score
Time frame: Day -7, Day 0, Day 28, Day 42, Day 84.
Change in Depression score
Time frame: Day 0, Day 28, Day 42, Day 84.
Change in trait anxiety
Time frame: Day 0, Day 28, Day 42, Day 84.
Change in perceived stress
Time frame: Day 0, Day 28, Day 42, Day 84.
Change in Stress
Time frame: Day 0, Day 42, Day 84.
Change in Sleep Quality
Time frame: Day 0, Day 28, Day 42, Day 84.
Change in Gastrotintestinal symptoms
Time frame: Day 0, Day 28, Day 42, Day 84.
Change in Quality of Life evaluation
Time frame: Day 0, Day 28, Day 42, Day 84.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Jan 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Probiotic in people with Anxiety, run by The Archer-Daniels-Midland Company at 1 site in Ireland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 0 inclusion and 28 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 22 Jan 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Ireland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Anxiety rating (time frame: Day 0, Day 42, Day 84.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Jan 2025.