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CompletedNCT05562739AnxUpdated Jan 22, 2025

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

An interventional study of Postbiotic and Placebo in Anxiety, sponsored by The Archer-Daniels-Midland Company. Completed at 1 site in Ireland. Open to participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2025-01-22.

Sponsored by The Archer-Daniels-Midland Company · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
10
Allocation
Randomized
Ages
18 Years to 65 Years
Sex
All
01

Study summary

This study evaluates the efficacy of a multistrain postbiotic administered in the form of a capsule in the management of moderate self-reported anxiety in adults aged 18-65

Read the detailed description

The subjects will be placebo non-responders from part 1 of the trial, looking at the effect of a multistrain probiotic on anxiety.

02

Conditions studied

  • Anxiety

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Keywords

  • probiotic
  • microbiome
  • postbiotic
03

In context

Anxiety Disorders

4,868 studies on the registry are indexed under Anxiety Disorders; 1,390 are open to participants now.

This study's enrollment of 10 is below the median of 80 across 4,174 interventional studies indexed under Anxiety Disorders.

Browse Anxiety Disorders studies →

Lead sponsor

The Archer-Daniels-Midland Company is the lead sponsor of 19 studies on the registry; 6 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 65 Years
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  1. Be able to give written informed consent.
  2. Be between 18 to 65 years inclusive.
  3. Mild to moderate self-reported anxiety
  4. Have a Beck Depression Inventory (BDI) score \<20.
  5. Is in general good health, as determined by the investigator.
  6. Be willing to maintain stable dietary habits and physical activity levels throughout the study period.
  7. 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.
  8. Willing to consume the study product daily for the duration of the trial and comply with all trial procedures.
  9. Be able to give confirmation of ongoing informed consent from Part 1 of the trial.
  10. Has been allocated to the placebo arm of Part I of the trial
  11. Has been deemed a "non-responder" in Part I of the trial

Exclusion criteria

Exclusion Criteria:

  1. Are less than 18 or greater than 65.
  2. Participants who are pregnant or wish to become pregnant during the trial.
  3. Participants who are lactating and/or currently breastfeeding
  4. Participants currently of childbearing potential, but not using an effective method of contraception, as outlined below:
  5. 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).
  6. Has a male sexual partner who is surgically sterilised prior to the Screening Visit and is the only male sexual partner for that Participant.
  7. Sexual partner(s) is/are exclusively female.
  8. 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.
  9. 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.
  10. Are hypersensitive to any of the components of the study product.
  11. Has taken systemic antibiotics within the previous 8 weeks.
  12. Has taken probiotics or post-biotics within the previous 8 weeks.
  13. Has a current clinical diagnosis of depression - determined in their medical history.
  14. Has self-reported or suspected consumption of excess quantities of alcohol or recreational drugs
  15. Diagnosed with significant physical comorbidity that, in the investigator's judgment, precludes involvement in the study.
  16. 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.
  17. 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.
  18. 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.
  19. Taking dietary supplements or food products that the investigator believes would interfere with the objectives of the study within 8 weeks prior to baseline ;
  20. Participants who have taken psychotropics, anxiolytics, antipsychotics, anticonvulsants, systemic corticosteroids, opioid pain relievers, hypnotics, and/or prescribed sleep medication within 8-weeks of screening.
  21. Has a gastrointestinal disease or condition, that by the investigators judgement, could interfere with the intestinal barrier function.
  22. 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)
  23. 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.
  24. Any immunosuppressant or chemotherapy medications, including mercaptopurine, azathioprine, or methotrexate;
  25. 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
  26. 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.
  27. 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.
  28. 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.
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Quadruple (Participant, Care provider, Investigator, Outcomes assessor)
Enrollment
10 participants (actual)

Study arms

  • Experimental
    Active

    Arm receiving investigational product (postbiotic)

    Dietary Supplement: Postbiotic

  • Placebo comparator
    Placebo

    Arm receiving placebo

    Dietary Supplement: Placebo

Interventions

  • Dietary supplementPostbiotic

    multistrain postbiotic in the form of a capsule with a daily dose of 1E+9 Colony Forming Unit (CFU) per day for 6 weeks.

  • Dietary supplementPlacebo

    Matching placebo in a form of a capsule for 6 weeks.

06

What researchers measure

Primary outcomes

  1. 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.

    Time frame: Day 0, Day 42

Secondary outcomes

  1. 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.

    Time frame: Day 0, Day 42

  2. 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.

    Time frame: Day 0, Day 42

  3. 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.

    Time frame: Day 0, Day 42

  4. 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.

    Time frame: Day 0, Day 42

  5. Change in Stress

    Level of stress measured with "Salivary Cortisol awakening response" (ng/dL).

    Time frame: Day 0, Day 42

  6. 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.

    Time frame: Day 0, Day 42

  7. Change in Gastrotintestinal symptoms

    Degree of GI symptoms measured by "GI Symptom Rating Scale" where a lower score means better outcomes compared to baseline.

    Time frame: Day 0, Day 42

  8. 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.

    Time frame: Day 0, Day 42

Other outcomes

  1. Change in GI microbiome

    Faecal microbiome analysis assessed by metagenomics.

    Time frame: Day 0, Day 42

07

Study locations

1 site
  • Atlantia Food Clinical Trials
    Cork, Ireland
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jan 22, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT05562739
Lead sponsor
The Archer-Daniels-Midland Company
Collaborators
Atlantia Food Clinical Trials
Responsible party
Sponsor
First posted
Oct 3, 2022
Start date
Jan 4, 2024
Primary completion
Feb 28, 2024
Completion
Feb 28, 2024
Last update
Jan 22, 2025

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Jan 2025. You cannot join it, but the record below documents what was studied.

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