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).
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Enrollment
190
Atlantia Food Clinical Trials Ltd
Cork, Ireland
MediNova Warwickshire Dedicated Research Centre
Kenilworth, United Kingdom
MediNova North London Dedicated Research Centre
Northwood, United Kingdom
MediNova Research East London Clinical Studies Centre
Romford, United Kingdom
State Trait Anxiety Inventory (STAI)-state total score
Absolute change in STAI-state total score between the active versus placebo group
Time frame: from baseline to 8 weeks
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.
Time frame: from baseline to 8 weeks
Change in perceived stress (Visual Analog Scale (VAS)-stress)
The absolute change in VAS-stress score will be analyzed in the same fashion as described for the primary variable. * Visual Analog Scale (VAS)-stress. * 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.
Time frame: 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. * Depression, anxiety, stress scale (21 items). * 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.
Time frame: 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. * Depression, anxiety, stress scale (21 items). * 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.
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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
Time frame: 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. * Depression, anxiety, stress scale (21 items). * 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.
Time frame: 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. * Hospital anxiety and depression scale. * The HADS is a 14 item self-report screening tool which is widely used in the clinic to assess levels of depression and anxiety.
Time frame: 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. * Hospital anxiety and depression scale. * The HADS is a 14 item self-report screening tool which is widely used in the clinic to assess levels of depression and anxiety.
Time frame: 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. * Cohen's perceived stress scale. * 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.
Time frame: 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. * Bond-Lader visual analogue scale. * 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: from baseline to 8 weeks