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| Name | Class |
|---|---|
| ICON plc | INDUSTRY |
| Daacro | NETWORK |
| 4Pharma Ltd. | INDUSTRY |
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The purpose of this clinical trial is to determine whether Probiotic can modulate the psychological stress experienced by healthy medical, dental and health science students preparing for university/institute of technology semester examination (s), measured by self-report scales and hypothalamic pituitary adrenal axis activity, compared with placebo.
The purpose of this clinical trial is to determine whether Probiotic can modulate the psychological stress experienced by healthy medical, dental and health science students preparing for university/institute of technology semester examination (s), measured by self-report scales and hypothalamic pituitary adrenal axis activity, compared with placebo.
The target group of the proposed study will consist of stress vulnerable / sensitive, healthy male and female adult participants currently enrolled in medical, dental or health science university course that are experiencing psychological stress induced by preparation for university/institute of technology semester examination (s).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Probiotic | Experimental | Probiotic |
|
| Placebo | Placebo Comparator | Placebo |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Probiotic | Biological | Probiotic |
| |
| Placebo |
| Measure | Description | Time Frame |
|---|---|---|
| State Trait Anxiety Inventory (STAI)-state total score | Absolute change in STAI-state total score between the active versus placebo group | from baseline to 8 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Cortisol awakening response (CAR) | The absolute changes in the CAR will be analyzed in the same fashion as described for the primary variable. | from baseline to 8 weeks |
| Change in perceived stress (Visual Analog Scale (VAS)-stress) |
| Measure | Description | Time Frame |
|---|---|---|
| IPAQ-short, physical activity level score | Changes in International Physical Activity Questionnaire (IPAQ)-short, physical activity level score | from baseline to 4 weeks, 8 weeks and 10 weeks |
| Detection of Probiotic in feces |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Balgit Chhokar | Medinova East London Dedicated Research Center | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Atlantia Food Clinical Trials Ltd | Cork | Ireland | ||||
| MediNova Warwickshire Dedicated Research Centre |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 37662485 | Derived | Makela SM, Griffin SM, Reimari J, Evans KC, Hibberd AA, Yeung N, Ibarra A, Junnila J, Turunen J, Beboso R, Chhokar B, Dinan TG, Cryan J, Patterson E. Efficacy and safety of Lacticaseibacillus paracasei Lpc-37(R) in students facing examination stress: A randomized, triple-blind, placebo-controlled clinical trial (the ChillEx study). Brain Behav Immun Health. 2023 Aug 1;32:100673. doi: 10.1016/j.bbih.2023.100673. eCollection 2023 Oct. |
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| ID | Term |
|---|---|
| D013315 | Stress, Psychological |
| ID | Term |
|---|---|
| D001526 | Behavioral Symptoms |
| D001519 | Behavior |
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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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| Other |
Placebo |
|
The absolute change in VAS-stress score will be analyzed in the same fashion as described for the primary variable.
| from baseline to 8 weeks |
| Change in DASS-21, depression scale score from baseline (Visit 3) to 8 weeks (Visit 5) | The absolute changes in DASS-21, depression scale score will be analyzed in the same fashion as described for the primary variable.
| from baseline to 8 weeks |
| Change in DASS-21, anxiety scale score from baseline (Visit 3) to 8 weeks (Visit 5) | The absolute changes in DASS-21, anxiety scale score will be analyzed in the same fashion as described for the primary variable.
| from baseline to 8 weeks |
| Change in DASS-21, stress scale score from baseline (Visit 3) to 8 weeks (Visit 5) | The absolute changes in DASS-21, stress scale score will be analyzed in the same fashion as described for the primary variable.
| from baseline to 8 weeks |
| Change in HADS, depression score from baseline (Visit 3) to 8 weeks (Visit 5) | The absolute changes in HADS, depression score will be analyzed in the same fashion as described for the primary variable.
| from baseline to 8 weeks |
| Change in HADS, anxiety score from baseline (Visit 3) to 8 weeks (Visit 5) | The absolute changes in HADS, anxiety score will be analyzed in the same fashion as described for the primary variable.
| from baseline to 8 weeks |
| Change in PSS, total score from baseline (Visit 3) to 8 weeks (Visit 5) | The absolute changes in PSS, total score will be analyzed in the same fashion as described for the primary variable.
| from baseline to 8 weeks |
| Change in BL-VAS, alertness score from baseline (Visit 3) to 8 weeks (Visit 5) | The absolute changes in BL-VAS, alertness score will be analyzed in the same fashion as described for the primary variable.
| from baseline to 8 weeks |
| Change in BL-VAS, contentment score | The absolute changes in BL-VAS, contentment score will be analyzed in the same fashion as described for the primary variable. | from baseline to 8 weeks |
| Change in BL-VAS, calmness score | The absolute changes in BL-VAS, calmness score will be analyzed in the same fashion as described for the primary variable. | from baseline to 8 weeks |
| Change in Pittsburgh Sleep Quality Index (PSQI), total score | The absolute changes in the PSQI, total score will be analyzed in the same fashion as described for the primary variable. | from baseline to 8 weeks |
| Change in PSQI, duration of sleep score | The absolute changes in the PSQI, duration of sleep score will be analyzed in the same fashion as described for the primary variable. | from baseline to 8 weeks |
| Change in PSQI, sleep disturbance score | The absolute changes in the PSQI, sleep disturbance score will be analyzed in the same fashion as described for the primary variable. | from baseline to 8 weeks |
| Change in PSQI, sleep latency score | The absolute changes in the PSQI, sleep latency score will be analyzed in the same fashion as described for the primary variable. | from baseline to 8 weeks |
| Change in PSQI, daytime dysfunction due to sleepiness score | The absolute changes in the PSQI, daytime dysfunction due to sleepiness score will be analyzed in the same fashion as described for the primary variable. | from baseline to 8 weeks |
| Change in PSQI, sleep efficiency score | The absolute changes in the PSQI, sleep efficiency score will be analyzed in the same fashion as described for the primary variable. | from baseline to 8 weeks |
| Change in PSQI, subjective sleep quality score | The absolute changes in the PSQI, subjective sleep quality score will be analyzed in the same fashion as described for the primary variable. | from baseline to 8 weeks |
| Change in PSQI, use of medication sleep score | The absolute changes in the PSQI, use of medication sleep score will be analyzed in the same fashion as described for the primary variable. | from baseline to 8 weeks |
| Change in evening cortisol | Evening cortisol: Participants will provide x1 saliva sample each evening during two consecutive working days at approximately 8pm prior to Visit 3, Visit 4, Visit 5 and Visit 6. Concentrations of cortisol will be assayed in saliva supernatants using ELISA kits specifically designed for cortisol quantification, following manufacturer's instructions. | from baseline to 8 weeks |
Changes in detection of Probiotic in feces
| from baseline to 8 weeks |
| STAI-state | Changes in State-trait anxiety inventory (STAI)-state, total score | from baseline to 4 weeks and 10 weeks |
| Changes in Cortisol awakening response (CAR) | Cortisol awakening response: Participants will provide x3 saliva samples each morning during two consecutive working days prior to Visit 3, Visit 4, Visit 5 and Visit 6. Concentrations of cortisol will be assayed in saliva supernatants using ELISA kits specifically designed for cortisol quantification, following manufacturer's instructions. | from baseline to 4 weeks and 10 weeks |
| Changes in evening cortisol | Evening cortisol: Participants will provide x1 saliva sample each evening during two consecutive working days at approximately 8pm prior to Visit 3, Visit 4, Visit 5 and Visit 6. Concentrations of cortisol will be assayed in saliva supernatants using ELISA kits specifically designed for cortisol quantification, following manufacturer's instructions. | from baseline to 4 weeks and 10 weeks |
| Changes in Visual Analog Scale (VAS)-stress (VAS-stress) | Visual Analog Scale (VAS)-stress (VAS-stress): Participants will complete the VAS-stress at clinic visits 2, 3, 4, 5 and 6. Participants indicate on a 100mm line how stressed they perceived themselves to be over the last week. The scale is anchored from 0 = felt not stressed at all to 100 = felt highly stressed. Scores are determined by measuring from the left end to the mark using a ruler. | from baseline to 4 weeks and 10 weeks |
| Depression, anxiety, stress scale (21 items) (DASS-21) |
Participants will complete the DASS-21 at clinic visits 2, 3, 4, 5 and 6. The DASS gives information about negative emotional states of depression, anxiety and stress. The questionnaire includes 3 scales (depression, anxiety and stress) of which each scale includes 7 items that are divided into subscales of 2-5 items of similar content. | from baseline to 4 weeks and 10 weeks |
| Hospital anxiety and depression scale (HADS) |
Participants will complete the HADS at clinic visit 2, 3, 4, 5 and 6. The HADS is a 14 item self-report screening tool which is widely used in the clinic to assess levels of depression and anxiety. It was developed as a tool for quick and easy use in a hospital setting, but has since been validated in primary care and in the community. | from baseline to 4 weeks and 10 weeks |
| Cohen's perceived stress scale (PSS) | o PSS, total score Participants will complete the PSS at clinic visits 2, 3, 4, 5 and 6. The PSS is a self-report measure in which participants rate, on a 5-point scale ranging from 0 (never) to 4 (very often), how often they have particular thoughts or feelings described by each of the 10 items. Scores range from 0-40, with higher scores indicating greater stress over the previous month. | from baseline to 4 weeks and 10 weeks |
| Bond-Lader visual analogue scale (BL-VAS) |
Participants will complete the BL-VAS at clinic visits 2, 3, 4, 5 and 6. The Bond-Lader VAS consist of 16 scales with anchors of related mood/ arousal dimensions (e.g. calm-excited; strong-feeble). Participants indicate on a 100mm line how they feel along each mood dimension at that specific time, and scores from the 16 scales are converted into three composite mood/ arousal dimensions; alertness, calmness and contentedness. | from baseline to 4 weeks and 10 weeks |
| Pittsburgh sleep quality index (PSQI) |
Participants will complete the PSQI at clinic visits 2, 3, 4, 5 and 6. The PSQI assesses sleep quality over the prior month. It is a self-report measure comprised of 19 items which are designed to measure 7 key components indicating either problematic or non-problematic sleep; sleep latency, sleep duration, sleep efficiency, sleep disturbances, subjective sleep quality, use of sleep medication and daytime dysfunction due to sleep disturbance. Scores on each component are combined to give a global score. Scores ≥5 indicate significant disturbances of sleep during the prior month. | from baseline to 4 weeks and 10 weeks |
| Fecal microbiota composition | Changes in fecal microbiota composition | from baseline to 8 weeks |
| Compliance of study product | Compliance of study product
| 10 weeks |
| Kenilworth |
| United Kingdom |
| MediNova North London Dedicated Research Centre | Northwood | United Kingdom |
| MediNova Research East London Clinical Studies Centre | Romford | United Kingdom |
| MediNova Yorkshire Dedicated Research Centre | Shipley | United Kingdom |
| MediNova South London Dedicated Research Centre, Queen Mary's Hospital | Sidcup | United Kingdom |
| MediNova West London Dedicated Research Centre | Wokingham | United Kingdom |
| D019602 |
| Food and Beverages |