A Double-blind, Placebo-controlled, Randomised Study to Assess the Effects of Bifidobacterium Longum 1714® in a Population With Low Mood
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Low Mood
- Sponsor
- PrecisionBiotics Group Ltd.
- Enrollment
- 168
- Locations
- 1
- Primary Endpoint
- Changes in depressive symptoms assessed by the Beck Depression Inventory (BDI-II)
- Status
- Completed
- Last Updated
- 3 years ago
Overview
Brief Summary
A randomised, double-blind, placebo-controlled clinical trial to evaluate the effect of 8 weeks of supplementation with Bifidobacterium longum 1714® strain on Beck's Depression Inventory-II Score in adults who experience low mood.
Detailed Description
This is a randomized, double-blind, placebo-controlled, parallel group study, designed to assess the effectiveness \& safety of Bifidobacterium longum 1714® strain in people with low mood. The 8-week intervention study will be conducted in 168 adults, aged ≥18 to ≤70 years, who experience low mood, and experience mild or moderate depression, according to the Beck's Depression Inventory II (Total score 14-28). The study will consist of 4 visits over a 10 week period commencing with a screening visit. The second visit will be the baseline (start of intervention - either active or placebo), followed by third (mid-intervention), fourth (end of treatment). Questionnaires will be administered from the first to the fifth visit and safety and research bloods will be collected at each visit throughout the trial.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Participants must be able to give written informed consent.
- •Male or female adults aged between ≥18 to ≤70 years.
- •Participants with a BMI between ≥18.5 and ≤29.9 kg/m
- •Meet the DSM-5 criteria for major depressive disorder (MDD) at screening (V0) and at baseline (V1).
- •BDI-II (Beck's Depression Inventory II) total score of 14-28 (mild \[14-19\] or moderate \[20-28\] depression) at screening (V0) and at baseline (V1).
- •Be willing to maintain stable dietary habits and physical activity levels throughout the study period.
- •Be able to communicate well with the Investigator, to understand and comply with the requirements of the study and be judged suitable for the study in the opinion of the Investigator.
Exclusion Criteria
- •Participants who are at risk of suicide.
- •Recent use of dietary supplements, probiotics, or other fermented foods that contain live bacteria within last 4 weeks.
- •Participant who has been on antibiotics during the past 3 months.
- •Participant with a malignant disease or any concomitant end-state organ disease and/or laboratory abnormalities considered by Investigators to be risky or that could interfere with data collection.
- •Participant who has a significant physical illness (including IBS, does not include people with controlled hypertension or type II diabetes).
- •Participant who is severely immunocompromised (HIV positive, transplant patient, on anti-rejection medications, on a steroid for \>30 days, or chemotherapy or radiotherapy within the last year).
- •Significant psychiatric diagnosis (e.g., bipolar) other than depression.
- •Participants who are on anxiolytics, anti-depressants, antipsychotics, anticonvulsants, centrally acting corticosteroids, opioid pain relievers, hypnotics, and/or prescribed sleep medication/ herbals (e.g., valerian, St. John's Wort).
- •Participants with a current history of drug (including illicit drug) and /or alcohol abuse at the time of enrolment.
- •Participants who are pregnant (determined by urine pregnancy test for all individuals of childbearing potential at screening, regardless of contraceptive use or relationship status), breastfeeding, or wish to become pregnant during the study.
Outcomes
Primary Outcomes
Changes in depressive symptoms assessed by the Beck Depression Inventory (BDI-II)
Time Frame: Change from baseline compared to placebo, assessed over 8 weeks of supplement intake
Severity of depression as measured by the BDI-II (range 0-63, with higher scores reflecting worse outcome)
Secondary Outcomes
- Change in subjective sleep quality, assessed by Pittsburgh Sleep Quality Index global score(Change from baseline compared to placebo, assessed over 8 weeks of supplement intake)
- Changes in mood category assessed by the Beck Depression Inventory (BDI-II)(Change from baseline compared to placebo, assessed at 4 weeks of supplement intake)
- Change in fatigue assessed by the Visual Analogue Scale (VAS) for fatigue.(Change from baseline compared to placebo, assessed over 8 weeks of supplement intake)
- Change in quality of life assessed by the Short Form-36(Change from baseline compared to placebo, assessed over 8 weeks of supplement intake)
- Change in depression severity category assessed by the Patient Health Questionnaire-9 (PHQ-9)(Change from baseline compared to placebo, assessed over 8 weeks of supplement intake)
- Change in stress assessed by the by Cohen's Perceived Stress Scale (PSS)(Change from baseline compared to placebo, assessed over 8 weeks of supplement intake)
- Changes in depressive symptoms assessed by the Beck Depression Inventory (BDI-II)(Change from baseline compared to placebo, assessed at 4 weeks of supplement intake)