A Double Blind, Placebo-Controlled, Randomized, Parallel-Group Study to Investigate the Efficacy of a Multi-Strain Probiotic Formulation in Alleviating Symptoms of Anxiety,Insomnia and Depression.
试验速览
- 阶段
- Phase 3 4
- 状态
- 尚未招募
- 发起方
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- Change in the following efficacy parameters assessed in the investigational product arm compared to placebo:
研究概览
简要总结
This is a double blind, randomized, placebo controlled, two-arms, parallel group study. A total of 100 moderately stressed adults meeting all inclusion and no exclusion criteria after signing informed consent will be enrolled in the study. After passing the eligibility criteria, the subjects will be randomized into 2 treatment arms in 1:1 ratio to receive either or treatment arm or placebo in capsule form, twice a day for period of 84 days. Questionnaire based assessments will be performed to evaluate the efficacy of the product .Blood samples will be collected for safety and biomarkers analysis. A diary shall be provided to the subjects to record the study IP administration, side effects, and concomitant medication details during the study duration. All subjects shall be instructed to complete the Subject Diary after each study IP administration. Any additional and missed administrations should also be noted in the Subject Diary. Subject Diary shall be used to evaluate study IP administration compliance.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- None
入排标准
- 年龄范围
- 18.00 Year(s) 至 80.00 Year(s)（—）
- 性别
- All
入选标准
- •1.Overall healthy subjects, those experiencing moderate mental health concerns such as moderate depression and anxiety disorder along with significant sleep disturbances (such as sleeplessness, depressive episode, recurrent depression, mixed depressive and anxiety disorder) assessed by:i.Beck’s depression Inventory (BDI-II): 21-30 score ii.Hamilton Anxiety Rating Scale (HAM-A): 18-24 score iii.Pittsburgh sleep Quality Index (PSQI): Greather than 5 score.
- •2.Females of childbearing age, agree to use approved birth control methods during the study, and have negative urine pregnancy test (UPT) at screening.
- •3.Willing to give written informed consent and comply with the study procedures.
排除标准
- •1.Subject with history of i.Use of any anti-depressant drug ii.Use of any antibiotic drug in the past 4 weeks iii.Use of natural health products that affect depression and sleep iv.Use of any sleep medication in the past 4 weeks v.Daily use of probiotic product in the past 2 weeks vi.Use of any type of laxative 2.Subjects with history of psychiatric disorders, severely suicidal and experiencing psychosis or bipolar episode 3.Subjects with of alcohol or substance abuse in the past 6 months4.Subjects with history of epilepsy or uncontrolled seizures 5.Women who are pregnant, breast feeding or planning to become pregnant during the trial 6.Subjects with known Immunodeficiency 7.Subjects with unstable medical conditions or serious diseases/ conditions (e.g. cancer, cardiovascular.
- •renal, lung, diabetes, psychiatric illness, bleeding disorders etc.) 8.Subjects with history of Electroconvulsive therapy (ECT) in the year prior to participation in the study.
- •9.Subjects taking antidepressant medication or other not-permitted treatment that cannot be safety discontinued.
- •10.A significant change in the treatment schema with proton-pump inhibitors, metformin, laxatives, systemic steroids, nonsteroidal anti-inflammatory drugs, antipsychotics, or any other medications influencing the microbiota according to present knowledge in the previous four weeks.
- •11.Subjects having hypersensitivity or history of allergy to any component of the study product.12.Unable to take medication orally or tolerate oral rehydration.13.History of gastric ulcer, duodenal ulcer, combined gastric and duodenal ulcers, upper gastrointestinal bleeding, autoimmune gastritis and GERD.14.Use of any proton pump inhibitor, sucralfate, H2-receptor antagonist, or bismuth preparations or any muscarine receptor antagonist and gastrin receptor antagonist within 2 weeks before initiating study IP therapy.15.Use of any other investigational drug currently or within 30 days prior to study entry.
- •16.Currently participating or having participated in another clinical trial during the last 3 months prior to the beginning of this study.
- •17.Any additional condition(s) that in the Investigators opinion would warrant exclusion from the study or prevent the subject from completing the study.
结局指标
主要结局
Change in the following efficacy parameters assessed in the investigational product arm compared to placebo:
时间窗: Baseline, Day 42, Day 84
Anxiety & Depression will be assessed through various questionnaires
时间窗: Baseline, Day 42, Day 84
次要结局
- Change in the efficacy parameters including biomarkers for stress, sleep, GI symptoms, inflammatory stress, depression, and alterations in gut microbiota.(Baseline, Day 42, Day 84)
- Overall Safety(Baseline, Day 42, Day 84)
研究者
Dr Mohan M E
BGS Global Institute of Medical Sciences