NCT04925440已完成不适用
A Double-blind, Placebo-controlled, Randomised Study to Assess the Effects of Bifidobacterium Longum 1714® in a Population With Low Mood
PrecisionBiotics Group Ltd.2 个研究点 分布在 1 个国家目标入组 168 人开始时间: 2021年9月13日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 168
- 试验地点
- 2
- 主要终点
- Changes in depressive symptoms assessed by the Beck Depression Inventory (BDI-II)
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •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.
排除标准
- •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.
- •Participants who are suffering from post-natal depression.
- •Participants currently of childbearing potential, but not using an effective method of contraception, as outlined below:
- •Complete abstinence from intercourse two weeks prior to administration of Investigational Product, throughout the clinical trial, until the completion of follow-up procedures or for two weeks following discontinuation of the Investigational Product in cases where participant discontinues the study prematurely. (Participants utilising this method must agree to use an alternate method of contraception if they should become sexually active and will be queried on whether they have been abstinent in the preceding 2 weeks when they present to the clinic for the Final Visit).
- •Has a male sexual partner who is surgically sterilised prior to the Screening Visit and is the only male sexual partner for that participant.
- •Sexual partner(s) is/are exclusively female.
- •Use of acceptable method of contraception, such as a spermicide, mechanical barrier (e.g., male condom, female diaphragm) or contraceptive pill. The participant must be using this method for at least 2 weeks prior to use of the Investigational Product and at least 1 week following the end of the study.
- •Use of any non-hormonal intrauterine device (IUD) or contraceptive implant with published data showing that the highest expected failure rate is less than 1 % per year. The participant must have the device inserted at least 2 weeks prior to the first Screening Visit, throughout the study, and 2 weeks following the end of the study.
- •Known allergy to any of the components of the test product.
- •Participation in a clinical study with an Investigational Product within 60 days before screening or plans to participate in another study during the study period.
- •Participant has a history of non-compliance or in the opinion of physician deemed unsuitable to participate in the study.
结局指标
主要结局
Changes in depressive symptoms assessed by the Beck Depression Inventory (BDI-II)
时间窗: 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)
次要结局
- 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)
研究者
研究点 (2)
Loading locations...
相似试验
进行中（未招募）
不适用
An Efficacy Trial in the Research Area of Gastrointestinal Health & BloatingGastrointestinal DysfunctionNCT05418127Coconut Goodness Food Products Inc.60
已完成
不适用
A human trial to evaluate the efficacy and safety of Echinacea extract on promotion of immunity enhancementKCT0006531Wonkwang University. Iksan Korean Medicine Hospital80
尚未招募
Unknown
Clinical trial to evaluate the efficacy and safety of SH003 of immunity functioDiseases of the respiratory systemKCT0009424Jaein R&P120
招募中
不适用
A 8 weeks, randomized, double-blind, placebo-controlled human trial to evaluate the efficacy and safety of Angelica gigas N. extract powder(Nutragen) on immune enhancementDiseases of the respiratory systemKCT0007832Jeonbuk National University Hospital100
招募中
不适用
the efficacy and safety of Triticum aestivum L. sprout extract on improvement of Liver functioDiseases of the digestive systemKCT0007271Woosuk University Korean Medicine Medical Center100