Participants were instructed to take either LactoSpore® or a placebo every morning for 90 days.
Researchers used questionnaires/scales to determine the effectiveness of the probiotic.
All primary measures of effectiveness for the LactoSpore® group were statistically significant on day 60 and this was maintained until the study ended. Measures included the positive changes in:
- Hamilton Rating Scale for Depression (measures depressed mood, feelings of guilt, suicide, insomnia, anxiety, agitation)
- Montgomery–Asberg Depression Rating Scale (measures inability to feel, pessimistic thoughts, suicidal thoughts, reduced appetite, reduced sleep, tension, sadness)
- Sleep quality and depressive symptom severity using 11-item Centre for Epidemiological Studies–Depression Scale (measures irritation, concentration level, depressed feelings, exhaustion, hopefulness, fearfulness, sleep, happiness, loneliness)
The following secondary efficacy parameters were also found to be statistically significant for the LactoSpore® group:
- Clinical Global Impression-Improvement (scale from very much improved to very much worse) and Severity Rating Scales (scale from normal to severely ill)
- Modified Epworth Sleepiness Scale (measures likelihood of dozing in specific situations)
Researchers also analysed serum myeloperoxidase, an inflammatory biomarker, before and after the trial:
- Significantly reduced in the LactoSpore® group but not placebo group. Inflammation is the culprit behind a multitude of health issues such as diabetes, Alzheimer’s, arthritis, heart disease and IBD.
 A biomarker is a measurable indicator of a biological process (e.g. there are indicators of inflammation that can be observed in blood tests)