Participants and experimental design
Anxiety, anxiety, Insomnia, depression, Depression
RECRUITMENT
We conducted this study to evaluate the effects of 3-week supplementation of JYLP-326 on the exam stress-induced behaviors in senior college students. Students who were nervously studying for the UNGEE during September to December 2020, a critical period for students to prepare the exam, were recruited from Nanchang University. All procedures were approved and complied with by the Institutional Ethics Committee on medical research of the Second Affiliated Hospital of Nanchang University (Examination and approval No. is Review [2020] No. (038)). All participants signed and informed consent.Following that, a total of 230 students were enrolled to interview and completed the 14-item of Hamilton Anxiety Scale (HAMA-14), 8-item of the 8-item Athens Insomnia Scale (AIS-8) and the 17-item Hamilton Depression Rating Scale (HDRS-17); out of 230, 60 with baselines HAMA-14 for anxiety score of 8 or higher and HDRS-17 for depression score of 8 or higher were screened (Study flow chart showing recruitment and group assignment.Out of those 60 students with anxiety and depression facing UNGEE, 30 were selected randomly as the PB group to receive the probiotic product; another 30 received placebo product were regarded as the P group. The 30 un-anxious students were assigned as the healthy control group (HP group). The subjects in each group were of the same age and the ratio of male to female was 1:1. The subjects in PB and P groups were instructed to take probiotic and placebo product twice per day for 3 consecutive weeks with a 12-hour set time between two intakes, respectively. While students in HP group were asked to maintain their normal lifestyle and diet habits. All treatments were stopped 2 weeks before UNGEE commenced. The validated questionnaires (i.e., HAMA-14, HDRS-17, and AIS-8) were provided to determine their mental conditions at baseline (Week 0) and the end of intervention (Week 3). The subjects were instructed to collect fecal samples by themselves at home using a stool sampling tube according to the manufacture’s introduction. The first pooped fecal sample in a day were collected during 3 days after the indicated time points and stored at -80 °C immediately for further research.