Clinical trial NCT06858046: Health Impacts of Street Vended Fruits
Official title: Health Impacts of Fresh Cut Street Vended Fruits: A Controlled Intervention Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Gastrointestinal Diseases
Foodborne Diseases
Microbial Contamination
Street Vended Foods
S. Aureus
Escherichia Coli
Total Viable Count
Keywords: Gastrointestinal Symptoms
Food borne illness
Food safety
Food borne infection
Food poisoning
S. aureus
E. coli
Bacterial contamination
Bacterial load
Lead sponsor: Bangladesh Agricultural University
Sponsor class: OTHER
First posted: 2025-03-05
Enrollment: 639
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: This study employs a randomized controlled intervention design with a parallel assignment model 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 assigned to one of seven arms: two treatment arms with 75 participants each (one with gastric acidity problems and one without), subdivided into three subgroups based on the type of fruit consumed (guava, pineapple, and watermelon). Additionally, a control group of 75 participants will not consume any fresh-cut street-vended fruits and will follow their usual dietary habits. The primary aim is to assess the microbial load (Total Viable Count, S. aureus, and E. coli) on fruits and its association with the development of GI symptoms. The study will employ statistical analysis techniques, including chi-square tests, relative risk analysis, and correlation studies, to evaluate the impact of fruit consumption on
Primary purpose: DIAGNOSTIC

Brief summary: 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.


Eligibility criteria: Inclusion Criteria:

* 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.

Exclusion Criteria:

* 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.

Primary outcomes:
measure: Prevalence of Gastrointestinal Symptoms Among Participants After Consumption of Fresh-Cut Fruits
timeFrame: From enrollment to the end of treatment at 10 days
Secondary outcomes:
Other outcomes:
Locations:
city: Mymensingh
country: Bangladesh
facility: Department of Microbiology and Hygiene, Bangladesh Agricultural University
Study officials:
affiliation: Bangladesh Agricultural University, Mymensingh
name: Md. Ariful Islam, PhD
role: PRINCIPAL_INVESTIGATOR
References: