Gastrointestinal DiseasesHISVFNCT06858046
Health Impacts of Street Vended Fruits
A study testing Fresh-Cut Guava Consumption, Fresh-Cut Pineapple Consumption and Fresh-Cut Watermelon Consumption in people with Gastrointestinal Diseases and Foodborne Diseases, run by Bangladesh Agricultural University at 1 site in Bangladesh.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Gastrointestinal Diseases, Foodborne Diseases, Microbial Contamination
- What is being tested?
- Fresh-Cut Guava Consumption, Fresh-Cut Pineapple Consumption and Fresh-Cut Watermelon Consumption
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 639 participants
- Where
- 1 siteBangladesh
- Study dates
- 6 Mar 2025to 19 Mar 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
Bangladesh1 site
Department of Microbiology and Hygiene, Bangladesh Agricultural University
Mymensingh, 2202
About this study
Official title: Health Impacts of Fresh Cut Street Vended Fruits: A Controlled Intervention Study
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.
- Conditions
- Gastrointestinal Diseases, Foodborne Diseases, Microbial Contamination, Street Vended Foods, S. Aureus, Escherichia Coli
- Being tested
- Fresh-Cut Guava Consumption, Fresh-Cut Pineapple Consumption, Fresh-Cut Watermelon Consumption, Fresh-Cut Guava Consumption (With Gastric Acidity), Fresh-Cut Pineapple Consumption (With Gastric Acidity)
- Keywords
- Gastrointestinal Symptoms, Food borne illness, Food safety, Food borne infection, Food poisoning, S. aureus, E. coli, Bacterial contamination, Bacterial load
- Medical subject headings
- Gastrointestinal Diseases, Foodborne Diseases, Staphylococcal Infections, Escherichia coli Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Fresh-Cut Guava ConsumptionDietary supplement
Participants eat a defined portion of guava.
Fresh-Cut Pineapple ConsumptionDietary supplement
Participants consumed fresh-cut pineapple purchased from street vendors. Health outcomes, including potential microbial contamination and GI symptoms, were assessed for five days after consumption.
Fresh-Cut Watermelon ConsumptionDietary supplement
Fresh-Cut Watermelon Consumption Description: Participants consumed fresh-cut watermelon obtained from street vendors. GI symptoms and microbial contamination effects were monitored for five days following consumption.
Fresh-Cut Guava Consumption (With Gastric Acidity)Dietary supplement
Same as intervention 2, but in participants with acidity
Fresh-Cut Pineapple Consumption (With Gastric Acidity)Dietary supplement
Same as intervention 3, but in participants with acidity.
Fresh-Cut Watermelon Consumption (With Gastric Acidity)Dietary supplement
Same as intervention 4, but in participants with acidity.
| Study group | Role | What they receive |
|---|---|---|
| Control Group (No Fresh-Cut Fruit Consumption) | No intervention | Participants in this group did not consume any street-vended fresh-cut fruits. They continued their usual dietary habits, avoiding any foods that could potentially cause irritation or foodborne illness. This group served as a baseline for comparison against the treatment groups. |
| Fresh-Cut Fruit Consumers with Gastric Acidity (Guava) | Experimental | Participants with pre-existing gastric acidity conditions consumed fresh-cut guava from street vendors. Their health status was monitored for five days post-consumption, focusing on gastrointestinal (GI) symptoms and microbial contamination effects. Receives: Dietary Supplement: Fresh-Cut Guava Consumption (With Gastric Acidity) |
| Fresh-Cut Fruit Consumers with Gastric Acidity (Pineapple) | Experimental | Participants with pre-existing gastric acidity conditions consumed fresh-cut pineapple from street vendors. Post-consumption symptoms and microbial contamination were assessed over a five-day period. Receives: Dietary Supplement: Fresh-Cut Pineapple Consumption (With Gastric Acidity) |
| Fresh-Cut Fruit Consumers with Gastric Acidity (Watermelon) | Experimental | Participants with pre-existing gastric acidity conditions consumed fresh-cut watermelon from street vendors. GI symptoms and potential microbial contamination effects were monitored for five days. Receives: Dietary Supplement: Fresh-Cut Watermelon Consumption (With Gastric Acidity) |
| Fresh-Cut Fruit Consumers without Gastric Acidity (Guava) | Experimental | Participants without pre-existing gastric acidity conditions consumed fresh-cut guava from street vendors. Health status was tracked for five days, with a focus on microbial contamination and foodborne illness symptoms. Receives: Dietary Supplement: Fresh-Cut Guava Consumption |
| Fresh-Cut Fruit Consumers without Gastric Acidity (Pineapple) | Experimental | Participants without pre-existing gastric acidity conditions consumed fresh-cut pineapple from street vendors. The study monitored their health for five days to evaluate any adverse effects. Receives: Dietary Supplement: Fresh-Cut Pineapple Consumption |
| Fresh-Cut Fruit Consumers without Gastric Acidity (Watermelon) | Experimental | Participants without pre-existing gastric acidity conditions consumed fresh-cut watermelon from street vendors. GI symptoms and microbial contamination effects were assessed over five days. Receives: Dietary Supplement: Fresh-Cut Watermelon Consumption |
What is being measured
The primary outcome is the main question the study is designed to answer.
Prevalence of Gastrointestinal Symptoms Among Participants After Consumption of Fresh-Cut Fruits
Measured: From enrollment to the end of treatment at 10 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Mar 2025
- Study start6 Mar 2025
- Primary completion19 Mar 2025
- Study completion19 Mar 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Gastrointestinal DiseasesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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
- Masking
- None (open label)
- Enrolment
- 639 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bangladesh Agricultural University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Md. Ariful Islam, Bangladesh Agricultural University
- Investigators
- Md. Ariful Islam, PhD, Principal investigator, Bangladesh Agricultural University, Mymensingh
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06858046
- Sponsor's protocol ID
- AWEEC/BAU/2024(2)/15(a)
- Other IDs
- AWEEC/BAU/2024(2)/15(a)
- Acronym
- HISVF
- Status last verified
- Mar 2025
- First submitted
- 23 Feb 2025
- Last updated
- 20 Mar 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 20 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Health Impacts of Fresh Cut Street Vended Fruits: A Controlled Intervention Study
- ClinicalTrials.gov ID
- NCT06858046
- Acronym / sponsor ID
- HISVF / AWEEC/BAU/2024(2)/15(a)
- Conditions
- Gastrointestinal Diseases, Foodborne Diseases, Microbial Contamination, Street Vended Foods, S. Aureus, Escherichia Coli
- Keywords
- Gastrointestinal Symptoms, Food borne illness, Food safety, Food borne infection, Food poisoning, S. aureus, E. coli, Bacterial contamination
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 639 participants (actual)
- Lead sponsor
- Bangladesh Agricultural UniversityUniversity, hospital or other
- Study start
- 6 Mar 2025 (actual)
- Primary completion
- 19 Mar 2025 (actual)
- Study completion
- 19 Mar 2025 (actual)
- First posted
- 5 Mar 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 7
- 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
| Arm | Type | Receives |
|---|---|---|
| Control Group (No Fresh-Cut Fruit Consumption) | No intervention | –Participants in this group did not consume any street-vended fresh-cut fruits. They continued their usual dietary habits, avoiding any foods that could potentially cause irritation or foodborne illness. This group served as a baseline for comparison against the treatment groups. |
| Fresh-Cut Fruit Consumers with Gastric Acidity (Guava) | Experimental | Dietary Supplement: Fresh-Cut Guava Consumption (With Gastric Acidity)Participants with pre-existing gastric acidity conditions consumed fresh-cut guava from street vendors. Their health status was monitored for five days post-consumption, focusing on gastrointestinal (GI) symptoms and microbial contamination effects. |
| Fresh-Cut Fruit Consumers with Gastric Acidity (Pineapple) | Experimental | Dietary Supplement: Fresh-Cut Pineapple Consumption (With Gastric Acidity)Participants with pre-existing gastric acidity conditions consumed fresh-cut pineapple from street vendors. Post-consumption symptoms and microbial contamination were assessed over a five-day period. |
| Fresh-Cut Fruit Consumers with Gastric Acidity (Watermelon) | Experimental | Dietary Supplement: Fresh-Cut Watermelon Consumption (With Gastric Acidity)Participants with pre-existing gastric acidity conditions consumed fresh-cut watermelon from street vendors. GI symptoms and potential microbial contamination effects were monitored for five days. |
| Fresh-Cut Fruit Consumers without Gastric Acidity (Guava) | Experimental | Dietary Supplement: Fresh-Cut Guava ConsumptionParticipants without pre-existing gastric acidity conditions consumed fresh-cut guava from street vendors. Health status was tracked for five days, with a focus on microbial contamination and foodborne illness symptoms. |
| Fresh-Cut Fruit Consumers without Gastric Acidity (Pineapple) | Experimental | Dietary Supplement: Fresh-Cut Pineapple ConsumptionParticipants without pre-existing gastric acidity conditions consumed fresh-cut pineapple from street vendors. The study monitored their health for five days to evaluate any adverse effects. |
| Fresh-Cut Fruit Consumers without Gastric Acidity (Watermelon) | Experimental | Dietary Supplement: Fresh-Cut Watermelon ConsumptionParticipants without pre-existing gastric acidity conditions consumed fresh-cut watermelon from street vendors. GI symptoms and microbial contamination effects were assessed over five days. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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).
Key exclusion criteria (8 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Fresh-Cut Guava ConsumptionParticipants eat a defined portion of guava. | Dietary supplement | Fresh-Cut Fruit Consumers without Gastric Acidity (Guava) |
| Fresh-Cut Pineapple ConsumptionParticipants consumed fresh-cut pineapple purchased from street vendors. Health outcomes, including potential microbial contamination and GI symptoms, were assessed for five days after consumption. | Dietary supplement | Fresh-Cut Fruit Consumers without Gastric Acidity (Pineapple) |
| Fresh-Cut Watermelon ConsumptionFresh-Cut Watermelon Consumption Description: Participants consumed fresh-cut watermelon obtained from street vendors. GI symptoms and microbial contamination effects were monitored for five days following consumption. | Dietary supplement | Fresh-Cut Fruit Consumers without Gastric Acidity (Watermelon) |
| Fresh-Cut Guava Consumption (With Gastric Acidity)Same as intervention 2, but in participants with acidity | Dietary supplement | Fresh-Cut Fruit Consumers with Gastric Acidity (Guava) |
| Fresh-Cut Pineapple Consumption (With Gastric Acidity)Same as intervention 3, but in participants with acidity. | Dietary supplement | Fresh-Cut Fruit Consumers with Gastric Acidity (Pineapple) |
| Fresh-Cut Watermelon Consumption (With Gastric Acidity)Same as intervention 4, but in participants with acidity. | Dietary supplement | Fresh-Cut Fruit Consumers with Gastric Acidity (Watermelon) |
Primary outcome
Prevalence of Gastrointestinal Symptoms Among Participants After Consumption of Fresh-Cut Fruits
Time frame: From enrollment to the end of treatment at 10 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Mar 2025.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Md. Ariful Islam, PhD principal investigator
Bangladesh Agricultural University, Mymensingh
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Fresh-Cut Guava Consumption, Fresh-Cut Pineapple Consumption and Fresh-Cut Watermelon Consumption in people with Gastrointestinal Diseases and Foodborne Diseases, run by Bangladesh Agricultural University at 1 site in Bangladesh.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 20 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Bangladesh. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Prevalence of Gastrointestinal Symptoms Among Participants After Consumption of Fresh-Cut Fruits (time frame: From enrollment to the end of treatment at 10 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Mar 2025.