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
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
The subjects will be placebo non-responders from part 1 of the trial, looking at the effect of a multistrain probiotic on anxiety.
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 →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.
Exclusion Criteria:
Arm receiving investigational product (postbiotic)
Dietary Supplement: Postbiotic
Arm receiving placebo
Dietary Supplement: Placebo
multistrain postbiotic in the form of a capsule with a daily dose of 1E+9 Colony Forming Unit (CFU) per day for 6 weeks.
Matching placebo in a form of a capsule for 6 weeks.
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
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
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
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
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
Change in Stress
Level of stress measured with "Salivary Cortisol awakening response" (ng/dL).
Time frame: Day 0, Day 42
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
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
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
Change in GI microbiome
Faecal microbiome analysis assessed by metagenomics.
Time frame: Day 0, Day 42
Plan to share: No
No publications or documents are linked to this record.
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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The Archer-Daniels-Midland Company