A Phase 2 interventional study of Probiotic and Placebo in Stress, Psychological and Healthy, sponsored by Danisco. Completed at 7 sites in 2 countries. Open to participants aged 18 Years to 40 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2020-03-25.
Sponsored by Danisco · Phase 2, Interventional, and Treatment
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).
783 studies on the registry are indexed under Stress, Psychological; 128 are open to participants now.
This study's enrollment of 190 is above the median of 85 across 632 interventional studies indexed under Stress, Psychological.
Browse Stress, Psychological studies →Danisco is the lead sponsor of 23 studies on the registry; 2 are open to participants now.
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Exclusion Criteria:
Probiotic
Biological: Probiotic
Placebo
Other: Placebo
Probiotic
Placebo
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.
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
IPAQ-short, physical activity level score
Changes in International Physical Activity Questionnaire (IPAQ)-short, physical activity level score
Time frame: from baseline to 4 weeks, 8 weeks and 10 weeks
Detection of Probiotic in feces
Changes in detection of Probiotic in feces
Time frame: from baseline to 8 weeks
STAI-state
Changes in State-trait anxiety inventory (STAI)-state, total score
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: from baseline to 4 weeks and 10 weeks
Depression, anxiety, stress scale (21 items) (DASS-21)
* DASS-21, depression scale score * DASS-21, anxiety scale score * DASS-21, stress scale score 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.
Time frame: from baseline to 4 weeks and 10 weeks
Hospital anxiety and depression scale (HADS)
* HADS, depression score * HADS, anxiety score 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.
Time frame: 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.
Time frame: from baseline to 4 weeks and 10 weeks
Bond-Lader visual analogue scale (BL-VAS)
* BL-VAS, alertness score * BL-VAS, contentment score * BL-VAS, calmness score 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.
Time frame: from baseline to 4 weeks and 10 weeks
Pittsburgh sleep quality index (PSQI)
* PSQI, total score; PSQI, duration of sleep score * PSQI, sleep disturbance score * PSQI, sleep latency score * PSQI, daytime dysfunction due to sleepiness score * PSQI, sleep efficiency score * PSQI, subjective sleep quality score * PSQI, use of medication sleep score 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.
Time frame: from baseline to 4 weeks and 10 weeks
Fecal microbiota composition
Changes in fecal microbiota composition
Time frame: from baseline to 8 weeks
Compliance of study product
Compliance of study product * Participants will be asked to return the remaining study products to the study site at each visit during the intervention period (Visit 4, 5 and 6) for study product accountability and accurate determination of compliance throughout the intervention period. * A study product inventory (dispensing records) will be used by site staff to record all study product dispensed and returned.
Time frame: 10 weeks
Plan to share: No
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This study is completed, as verified in Mar 2020. You cannot join it, but the record below documents what was studied.
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