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| ID | Type | Description | Link |
|---|---|---|---|
| AFCRO-154 | Other Identifier | CRO |
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| Name | Class |
|---|---|
| Atlantia Food Clinical Trials | INDUSTRY |
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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
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Active | Experimental | Arm receiving investigational product (probiotic) |
|
| Placebo | Placebo Comparator | Arm receiving placebo |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Probiotic | Dietary 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. |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Day 0, Day 42, Day 84. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Day -7, Day 0, Day 28, Day 42, Day 84. |
| Change in Depression score |
| Measure | Description | Time Frame |
|---|---|---|
| Change in GI microbiome | Faecal microbiome analysis assessed by metagenomics. | Day 0, Day 84. |
Part 1 Inclusion Criteria:
Part 2 Inclusion Criteria (see separate trial):
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Atlantia Food Clinical Trials | Cork | Ireland |
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| ID | Term |
|---|---|
| D001008 | Anxiety Disorders |
| ID | Term |
|---|---|
| D001523 | Mental Disorders |
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| ID | Term |
|---|---|
| D019936 | Probiotics |
| ID | Term |
|---|---|
| D019587 | Dietary Supplements |
| D005502 | Food |
| D000066888 | Diet, Food, and Nutrition |
| D010829 | Physiological Phenomena |
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Study consists of 2 parts with the participants in part 2 being recruited from "Placebo non-responders" in Part 1.
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| Placebo | Dietary Supplement | Matching placebo in a form of a capsule for 12 weeks. |
|
Level of depression measured with "Patient Health Questionnaire 9". (max 27 points) where a lower score means better outcomes compared to baseline.
| 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. | 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. | Day 0, Day 28, Day 42, Day 84. |
| Change in Stress | Level of stress measured with "Salivary Cortisol awakening response" (ng/dL). | 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. | 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. | 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. | Day 0, Day 28, Day 42, Day 84. |
| D019602 |
| Food and Beverages |