Health Impacts of Fresh Cut Street Vended Fruits: a Controlled Intervention Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 639
- 试验地点
- 2
- 主要终点
- Prevalence of Gastrointestinal Symptoms Among Participants After Consumption of Fresh-Cut Fruits
研究概览
简要总结
This study will employ a randomized controlled intervention design to evaluate the health impacts of consuming fresh-cut street-vended fruits, focusing on microbial contamination and gastrointestinal (GI) symptoms. A total of 300 participants will be recruited and divided into treatment (consuming guava, pineapple, or watermelon) and control groups (no fruit consumption). Fruit samples will be analyzed for microbial contamination, including S. aureus and E. coli, using standard microbiological and molecular techniques. Data on GI symptoms will be collected through questionnaires and analyzed using statistical methods, such as Chi-square tests, Kaplan-Meier survival analysis, and Cox proportional hazards regression. Spearman correlation will identify associations between bacterial presence and specific symptoms. Ethical approval will be obtained, and participant safety will be prioritized. Analytical tools, including IBM SPSS, RStudio, and PyCharm, will be utilized for the analyses.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Diagnostic
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Individuals aged 18-60 years.
- •Residents of Mymensingh District, Bangladesh.
- •Willing to consume fresh-cut street-vended fruits (guava, pineapple, or watermelon) for five consecutive days.
- •Individuals with a self-reported history of gastric acidity issues (for the gastric acidity arms).
- •Individuals with no history of gastric acidity (for the non-gastric acidity arms).
- •Participants who have not taken antibiotics, proton pump inhibitors (PPIs), or antacids in the last two weeks.
- •Willing to provide detailed information on their dietary habits and gastrointestinal symptoms through surveys/questionnaires.
- •Participants who provide informed consent for participation.
排除标准
- •Individuals under 18 years or over 60 years.
- •Pregnant or lactating women.
- •Those with a diagnosed gastrointestinal disorder (e.g., peptic ulcer disease, irritable bowel syndrome, Crohn's disease).
- •Individuals with a history of chronic infections or immune-compromising conditions (e.g., HIV/AIDS, cancer, diabetes).
- •Participants who have taken antibiotics, PPIs, or antacids within the last two weeks.
- •Individuals with known allergies to guava, pineapple, or watermelon.
- •Those who refuse to consume fresh-cut fruits from street vendors.
- •Participants who do not provide informed consent or are unable to complete the study period.
结局指标
主要结局
Prevalence of Gastrointestinal Symptoms Among Participants After Consumption of Fresh-Cut Fruits
时间窗: From enrollment to the end of treatment at 10 days
次要结局
未报告次要终点
研究者
Md. Ariful Islam
Prof. Dr.
Bangladesh Agricultural University