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| Name | Class |
|---|---|
| Innovate UK | OTHER_GOV |
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The goal of this clinical trial is to find out whether taking probiotics can improve thinking ability and gut (digestive) symptoms in healthy adults. The study will also explore whether probiotics affect mental health, alcohol cravings, and drinking and eating behaviours.
The main questions it aims to answer are:
Researchers will compare a probiotic supplement to a placebo (a look-alike product with no active ingredients) to see whether probiotics have real effects. Participants will be randomly assigned to one of these groups, and neither the participants nor the researchers will know who is receiving which treatment during the study.
Participants will:
This study aims to better understand whether probiotics could be a simple and low-cost way to support cognitive function, digestive health and other wellbeing outcomes in generally healthy adults.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Placebo Group | Placebo Comparator |
| |
| Probiotic Group | Active Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Probiotic Arm | Dietary Supplement | The participant will be randomly assigned to receive the probiotic, containing the active ingredient and live bacteria |
|
| Measure | Description | Time Frame |
|---|---|---|
| 85 non-clinical participants assessed for Everyday Cognitive Failures by Cognitive Failures Questionnaire 2.0 | Everyday cognitive functioning will be assessed using the Cognitive Failures Questionnaire 2.0 (CFQ 2.0), a 15-item self-report questionnaire measuring the frequency of cognitive lapses in daily life (e.g., memory, attention, and action errors). Each item is rated on a 5-point scale. Total scores are calculated by summing all item responses, yielding a score ranging from 0 to 60. Performance will be measured as the total CFQ 2.0 score (range 0-60), with higher scores indicating greater frequency of cognitive failures. | From enrollment to the end of the treatment at 8 weeks |
| 85 non-clinical participants assessed for Gastrointestinal Symptoms by Gastrointestinal Symptom Rating Scale | Gastrointestinal symptoms will be assessed using the Gastrointestinal Symptom Rating Scale (GSRS), a 15-item self-report questionnaire evaluating the severity of common gastrointestinal symptoms. Each item is rated on a 7-point Likert scale, with higher scores indicating more severe symptoms. Total scores are calculated by summing all item responses, yielding a score ranging from 15 to 105. Performance will be measured as the total GSRS score (range 15-105), with higher scores indicating greater gastrointestinal symptom severity. Domain scores may also be calculated by averaging relevant items to assess specific symptom clusters. | From enrollment to the end of the treatment at 8 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| 85 non-clinical participants assessed for Drinking Behaviour by Loughborough Alcohol Drinking Questionnaire | Drinking behaviour will be assessed using the Loughborough Alcohol Drinking Questionnaire (LoAD-Q), a 33-item self-report questionnaire measuring three dimensions: emotional drinking, external drinking, and restrained drinking. Each item is rated on a 5-point Likert scale (1 = never to 5 = very often). Subscale scores are calculated by summing item responses within each dimension. The emotional drinking subscale (13 items) has a score range of 13 to 65, the external drinking subscale (10 items) ranges from 10 to 50, and the restrained drinking subscale (10 items) ranges from 10 to 50. Performance will be measured as subscale total scores, with higher scores indicating greater levels of emotional, external, and restrained drinking behaviour, respectively. |
| Measure | Description | Time Frame |
|---|---|---|
| 85 non-clinical participants assessed for Disordered Eating by Eating Disorder Examination Questionnaire Short Form | Disordered eating behaviours will be assessed using the Eating Disorder Examination Questionnaire Short Form (EDE-QS), a 12-item self-report questionnaire measuring eating disorder psychopathology over the past 7 days. Each item is rated on a 4-point scale (0-3), yielding a total score ranging from 0 to 36. Performance will be measured as the total EDE-QS score (range 0-36), with higher scores indicating greater severity of disordered eating behaviours. |
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Loughborough University | Loughborough | United Kingdom |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Sep 17, 2025 | Mar 26, 2026 | Prot_000.pdf |
| ICF | No | No | Yes | Informed Consent Form | Jun 5, 2025 | Mar 26, 2026 | ICF_001.pdf |
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| Placebo Arm | Dietary Supplement | The participant will be randomly assigned to receive the placebo, containing no active ingredient/live bacteria |
|
| From enrollment to the end of the treatment at 8 weeks |
| 85 non-clinical participants assessed for Depression, Anxiety, and Stress by Depression Anxiety Stress Scales-12 | Mental health symptoms will be assessed using the Depression Anxiety Stress Scales-12 (DASS-12), a 12-item self-report questionnaire measuring symptoms of depression, anxiety, and stress. Each item is rated on a 4-point Likert scale (0-3), yielding a total score ranging from 0 to 36. Performance will be measured as the total DASS-12 score (range 0-36), with higher scores indicating greater psychological distress. | From enrollment to the end of the treatment at 8 weeks |
| 85 non-clinical participants assessed for Alcohol Craving by Penn Alcohol Craving Scale | Alcohol craving will be assessed using the Penn Alcohol Craving Scale (PACS), a 5-item self-report questionnaire measuring frequency, intensity, and duration of alcohol cravings over the past week. Each item is rated on a scale from 0 to 6, yielding a total score ranging from 0 to 30. Performance will be measured as the total PACS score (range 0-30), with higher scores indicating greater alcohol craving severity. | From enrollment to the end of the treatment at 8 weeks |
| From enrollment to the end of the treatment at 8 weeks |