Pesticide Adverse ReactionNCT05828563
Immunological Indices and Infections Among Pesticide Applicators in Sohag Governorate
A study testing Blood sample test in people with Pesticide Adverse Reaction, run by Sohag University at 1 site in Egypt.
Trial summary
The human body gets exposure to pesticides either directly or indirectly. By using pesticides on crops, humans come in direct contact with them and they affect the heaith Immune system is the first defense line against pathogenic organisms; however, it is altered by the vulnerable environmental factors such as… Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Pesticide Adverse Reaction
- What is being tested?
- Blood sample test
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteEgypt
- Study dates
- 1 May 2023to 1 May 2024
- 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 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- pesticide applicators
- Age ;20-60 years
- Exposure to pesticides for more than 3 months
Who cannot join
- Subjects have recent severe trauma or surgery or recent infections
Trial locations and contacts
1 site in 1 country.
About this study
The human body gets exposure to pesticides either directly or indirectly. By using pesticides on crops, humans come in direct contact with them and they affect the heaith
Immune system is the first defense line against pathogenic organisms; however, it is altered by the vulnerable environmental factors such as pesticides, which can cause structural or functional alterations in humoral or cell mechanisms (nonspecific or adaptive) of the immune response which lead to an increase in the susceptibility to infections
- Conditions
- Pesticide Adverse Reaction
- Being tested
- Blood sample test
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Blood sample testDiagnostic test
Blood sample will be taken to determine immunological indices
| Study group | Role | What they receive |
|---|---|---|
| pesticide applicators | Active comparator | This group contain cases Receives: Diagnostic Test: Blood sample test |
| control | Active comparator | control group Receives: Diagnostic Test: Blood sample test |
What is being measured
The primary outcome is the main question the study is designed to answer.
immunlogical indices
immunoglobulins (IgG ,IgE)
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Apr 2023
- Study start1 May 2023 (estimated)
- Primary completion1 May 2024 (estimated)
- Study completion1 May 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Pesticide Adverse ReactionStudies of the same condition, open and under way.
- More trials run by Sohag UniversityThe sponsor's other registered studies.
- 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
- Masking
- None (open label)
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sohag University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Yara Mohamed Ahmed, Sohag University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05828563
- Sponsor's protocol ID
- Soh-Med-23-4-05MS
- Status last verified
- Apr 2023
- First submitted
- 13 Apr 2023
- Last updated
- 25 Apr 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Hadnagy W, Leng G, Sugiri D, Ranft U, Idel H. Pyrethroids used indoors--immune status of humans exposed to pyrethroids following a pest control operation--a one year follow-up study. Int J Hyg Environ Health. 2003 Mar;206(2):93-102. doi: 10.1078/1438-4639-00201.
PubMed 12708230Kalyabina VP, Esimbekova EN, Kopylova KV, Kratasyuk VA. Pesticides: formulants, distribution pathways and effects on human health - a review. Toxicol Rep. 2021 Jun 6;8:1179-1192. doi: 10.1016/j.toxrep.2021.06.004. eCollection 2021.
PubMed 34150527Zhang W, Lin Z, Pang S, Bhatt P, Chen S. Insights Into the Biodegradation of Lindane (gamma-Hexachlorocyclohexane) Using a Microbial System. Front Microbiol. 2020 Mar 27;11:522. doi: 10.3389/fmicb.2020.00522. eCollection 2020.
PubMed 32292398
Study at a glance
From the registry record, last updated by the sponsor on 25 Apr 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Immunological Indices and Infections Among Pesticide Applicators in Sohag Governorate
- ClinicalTrials.gov ID
- NCT05828563
- Acronym / sponsor ID
- Soh-Med-23-4-05MS
- Conditions
- Pesticide Adverse Reaction
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Sohag UniversityUniversity, hospital or other
- Study start
- 1 May 2023 (estimated)
- Primary completion
- 1 May 2024 (estimated)
- Study completion
- 1 May 2024 (estimated)
- First posted
- 25 Apr 2023 (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.
The human body gets exposure to pesticides either directly or indirectly. By using pesticides on crops, humans come in direct contact with them and they affect the heaith
Immune system is the first defense line against pathogenic organisms; however, it is altered by the vulnerable environmental factors such as pesticides, which can cause structural or functional alterations in humoral or cell mechanisms (nonspecific or adaptive) of the immune response which lead to an increase in the susceptibility to infections
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| pesticide applicators | Active comparator | Diagnostic Test: Blood sample testThis group contain cases |
| control | Active comparator | Diagnostic Test: Blood sample testcontrol group |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- pesticide applicators
- Age ;20-60 years
- Exposure to pesticides for more than 3 months
Key exclusion criteria (1 listed)
- Subjects have recent severe trauma or surgery or recent infections
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 |
|---|---|---|
| Blood sample testBlood sample will be taken to determine immunological indices | Diagnostic test | control, pesticide applicators |
Primary outcome
immunlogical indices
Time frame: 12 months
immunoglobulins (IgG ,IgE)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Apr 2023.
- Background: PubMed 12708230Hadnagy W, Leng G, Sugiri D, Ranft U, Idel H. Pyrethroids used indoors--immune status of humans exposed to pyrethroids following a pest control operation--a one year follow-up study. Int J Hyg Environ Health. 2003 Mar;206(2):93-102. doi: 10.1078/1438-4639-00201.
- Background: PubMed 34150527Kalyabina VP, Esimbekova EN, Kopylova KV, Kratasyuk VA. Pesticides: formulants, distribution pathways and effects on human health - a review. Toxicol Rep. 2021 Jun 6;8:1179-1192. doi: 10.1016/j.toxrep.2021.06.004. eCollection 2021.
- Background: PubMed 32292398Zhang W, Lin Z, Pang S, Bhatt P, Chen S. Insights Into the Biodegradation of Lindane (gamma-Hexachlorocyclohexane) Using a Microbial System. Front Microbiol. 2020 Mar 27;11:522. doi: 10.3389/fmicb.2020.00522. eCollection 2020.
- Individual participant dataSharing planned: Undecided
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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Blood sample test in people with Pesticide Adverse Reaction, run by Sohag University at 1 site in Egypt.
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 3 inclusion and 1 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: status not confirmed, as of the sponsor's last update on 25 Apr 2023. 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 Egypt. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact yara M Ahmed, demonstrator (01019246020, yaramohamed@med.sohag.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
immunlogical indices (time frame: 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05828563, which also lists 3 linked publications.
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 25 Apr 2023; AzTrials last refreshed its copy on 8 Nov 2026.