The Gut Brain Axis, Effect of Dietary Changes and Probiotics Supplement on Depression Symptoms
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 76
- 试验地点
- 1
- 主要终点
- Depression score using arabic version of PHQ9
研究概览
简要总结
To investigate the effects of a high-fiber diet and probiotic supplementation on depression symptoms in adult individuals.
详细描述
Depression is prevalent mental health disorder that significantly impacts individuals' quality of life. Despite the availability of effective treatments such as pharmacotherapy and psychotherapy, there are still significant limitations to these approaches. Medications can have unwanted side effects and may not be effective for all patients, while psychotherapy can be time-consuming and expensive. Furthermore, many individuals may not have access to these treatments due to financial, geographical, or cultural barriers.
A more recent study published in the Journal of Pediatric Gastroenterology and Nutrition in 2020 investigated the effects of a probiotic supplement on gastrointestinal symptoms and quality of life in children with functional abdominal pain. The study found that the probiotic supplement improved gastrointestinal symptoms and quality of life in the children.
Overall, while there is limited research on probiotics in Egypt, the available studies suggest that probiotics may have potential health benefits for various populations. However, further research is needed to better understand the optimal types, doses and duration of probiotic supplementation for specific health outcomes in Egyptian populations.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Healthy individuals aged 18 to 65 years.
- •Both sexes.
排除标准
- •Pregnancy or lactation
- •Recent use of antibiotics or corticosteroids (within the past 3 months)
- •Chronic medical conditions that may interfere with study participation or interpretation of results (e.g., hypo or hyperthyroidism , cancer, diabetes, cardiovascular disease)
- •Current or past diagnosis of major depressive disorder or anxiety disorder
- •Current use of antidepressant or anxiolytic medications
- •History of gastrointestinal disorders or diseases (e.g., inflammatory bowel disease, celiac disease , malabsorbtion )
- •History of substance abuse or dependence
结局指标
主要结局
Depression score using arabic version of PHQ9
时间窗: For 12 weeks after dietary supplement
Depression score using arabic version of PHQ9 was recorded .The PHQ-9 (Patient Health Questionnaire-9) is a tool used to assess the severity of depression. It consists of nine questions, each related to symptoms experienced over the past two weeks. Each question is scored from 0 to 3, with the total score ranging from 0 to 27.
次要结局
- The safety of the dietary(For 12 weeks after dietary supplement)
- Tolerability of the dietary intervention(For 12 weeks after dietary supplement)
- Tolerability of probiotics(For 12 weeks after dietary supplement)
研究者
Salma Hosny Abd-allah Mohamed
Demonstrator in Family Medicine Department- Faculty of Medicine- Cairo University
Kasr El Aini Hospital