CryptosporidiosisNCT05208970
Cryptosporidium Species in Sohag Governorate
An observational study of Cryptosporidiosis, run by Sohag University at 1 site in Egypt.
Trial summary
Cryptosporidium species are increasingly recognized as important enteric pathogens that infect a broad range of hosts including human, domestic and wild animals worldwide, causing asymptomatic or mild-to-severe gastrointestinal disease in their host species. Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Cryptosporidiosis
- How many people
- 200 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Mar 2022to Jan 2025
- Phase
- Observational
- 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 Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Study population: Outpatients at Sohag University Hospital will be sampled.
Who may be able to join
- Age: any age
- Sex: male -female
- Residence: rural-urban
- Animal contact.
- Immune status: immunocompetent - immunocompromised
- Clinical manifestations: diarrhea -abdominal pain- fever- vomiting.
Who cannot join
- patients taking treatment for cryptosporidiosis
Trial locations and contacts
1 site in 1 country.
Egypt1 site, 1 recruiting
- Recruiting
Faculty of Medicine, Sohag University
Sohag
Salwa GA Omran, assistant lecturer, 01011154173 ext. +20, salwa.omran@med.sohag.edu.com
About this study
Official title: Genetic Diversity of Cryptosporidium Species Infecting Human in Sohag Governorate
Cryptosporidium species are increasingly recognized as important enteric pathogens that infect a broad range of hosts including human, domestic and wild animals worldwide, causing asymptomatic or mild-to-severe gastrointestinal disease in their host species.
There are 38 species of Cryptosporidium that have been described, going from amphibian parasites to mammals ones, with over 40 genotypes infecting mammals, although Cryptosporidium parvum and Cryptosporidium hominis are the two species predominantly reported in human infections. In Cairo and Sharkyia governorates in Egypt, Cryptosporidium is a common intestinal parasite among children, especially in diarrheic, preschool-aged children, with a predominance of C. hominis indicates anthroponotic rather than zoonotic transmission. Also in the sohag governorate, Cryptosporidium infection is a common intestinal parasite, as in the last five years its prevalence about 35% but there is no study clarify predominant genotype of Cryptosporidium in sohag.
- Conditions
- Cryptosporidiosis
- Medical subject headings
- Cryptosporidiosis
What is being measured
The primary outcome is the main question the study is designed to answer.
estimate the prevalence and clarify the species and genotypes/subtypes of Cryptosporidium spp. in sohag.
Measured: 24 weeks
Secondary outcomes (3)
clarify the relationship of them in a phylogenetic context and to provide additional information on the molecular epidemiology of this parasite in our locality
Measured: 24 weeks
clarify the predominant clinical manifestation of each genotypes/subtypes of Cryptosporidium spp
Measured: 24 weeks
clarify the relationship between genotypes/subtypes of Cryptosporidium spp. and different risk factors.
Measured: 24 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jan 2022
- Study start1 Mar 2022
- Primary completionDec 2024 (estimated)
- Study completionJan 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for CryptosporidiosisStudies 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
- Observational
- Observational model
- Case only
- Time perspective
- Cross-sectional
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sohag University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Salwa Gamal Ahmed Omran, Sohag University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05208970
- Sponsor's protocol ID
- Soh-Med-22-01-12
- Status last verified
- Apr 2024
- First submitted
- 12 Jan 2022
- Last updated
- 17 Apr 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Benamrouz S, Guyot K, Gazzola S, Mouray A, Chassat T, Delaire B, Chabe M, Gosset P, Viscogliosi E, Dei-Cas E, Creusy C, Conseil V, Certad G. Cryptosporidium parvum infection in SCID mice infected with only one oocyst: qPCR assessment of parasite replication in tissues and development of digestive cancer. PLoS One. 2012;7(12):e51232. doi: 10.1371/journal.pone.0051232. Epub 2012 Dec 13.
PubMed 23272093Ryan U, Zahedi A, Paparini A. Cryptosporidium in humans and animals-a one health approach to prophylaxis. Parasite Immunol. 2016 Sep;38(9):535-47. doi: 10.1111/pim.12350.
PubMed 27454991Kvac M, Havrdova N, Hlaskova L, Dankova T, Kandera J, Jezkova J, Vitovec J, Sak B, Ortega Y, Xiao L, Modry D, Chelladurai JR, Prantlova V, McEvoy J. Cryptosporidium proliferans n. sp. (Apicomplexa: Cryptosporidiidae): Molecular and Biological Evidence of Cryptic Species within Gastric Cryptosporidium of Mammals. PLoS One. 2016 Jan 15;11(1):e0147090. doi: 10.1371/journal.pone.0147090. eCollection 2016.
PubMed 26771460Mohammad SM, Ali MS, Abdel-Rahman SA, Moustafa RA, Sarhan MH. Genotyping of Cryptosporidium species in children suffering from diarrhea in Sharkyia Governorate, Egypt. J Infect Dev Ctries. 2021 Oct 31;15(10):1539-1546. doi: 10.3855/jidc.14367.
PubMed 34780378
Study at a glance
From the registry record, last updated by the sponsor on 17 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Genetic Diversity of Cryptosporidium Species Infecting Human in Sohag Governorate
- ClinicalTrials.gov ID
- NCT05208970
- Acronym / sponsor ID
- Soh-Med-22-01-12
- Conditions
- Cryptosporidiosis
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Sohag UniversityUniversity, hospital or other
- Study start
- 1 Mar 2022 (actual)
- Primary completion
- Dec 2024 (estimated)
- Study completion
- Jan 2025 (estimated)
- First posted
- 26 Jan 2022 (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.
Cryptosporidium species are increasingly recognized as important enteric pathogens that infect a broad range of hosts including human, domestic and wild animals worldwide, causing asymptomatic or mild-to-severe gastrointestinal disease in their host species.
There are 38 species of Cryptosporidium that have been described, going from amphibian parasites to mammals ones, with over 40 genotypes infecting mammals, although Cryptosporidium parvum and Cryptosporidium hominis are the two species predominantly reported in human infections. In Cairo and Sharkyia governorates in Egypt, Cryptosporidium is a common intestinal parasite among children, especially in diarrheic, preschool-aged children, with a predominance of C. hominis indicates anthroponotic rather than zoonotic transmission. Also in the sohag governorate, Cryptosporidium infection is a common intestinal parasite, as in the last five years its prevalence about 35% but there is no study clarify predominant genotype of Cryptosporidium in sohag.
Study design
- Observational model
- Case only
- Time perspective
- Cross-sectional
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Outpatients at Sohag University Hospital will be sampled.
Key inclusion criteria (6 listed)
- Age: any age
- Sex: male -female
- Residence: rural-urban
- Animal contact.
- Immune status: immunocompetent - immunocompromised
Key exclusion criteria (1 listed)
- patients taking treatment for cryptosporidiosis
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
estimate the prevalence and clarify the species and genotypes/subtypes of Cryptosporidium spp. in sohag.
Time frame: 24 weeks
3 secondary outcomes
clarify the relationship of them in a phylogenetic context and to provide additional information on the molecular epidemiology of this parasite in our locality
Time frame: 24 weeks
clarify the predominant clinical manifestation of each genotypes/subtypes of Cryptosporidium spp
Time frame: 24 weeks
clarify the relationship between genotypes/subtypes of Cryptosporidium spp. and different risk factors.
Time frame: 24 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Apr 2024.
- Background: PubMed 23272093Benamrouz S, Guyot K, Gazzola S, Mouray A, Chassat T, Delaire B, Chabe M, Gosset P, Viscogliosi E, Dei-Cas E, Creusy C, Conseil V, Certad G. Cryptosporidium parvum infection in SCID mice infected with only one oocyst: qPCR assessment of parasite replication in tissues and development of digestive cancer. PLoS One. 2012;7(12):e51232. doi: 10.1371/journal.pone.0051232. Epub 2012 Dec 13.
- Background: PubMed 27454991Ryan U, Zahedi A, Paparini A. Cryptosporidium in humans and animals-a one health approach to prophylaxis. Parasite Immunol. 2016 Sep;38(9):535-47. doi: 10.1111/pim.12350.
- Background: PubMed 26771460Kvac M, Havrdova N, Hlaskova L, Dankova T, Kandera J, Jezkova J, Vitovec J, Sak B, Ortega Y, Xiao L, Modry D, Chelladurai JR, Prantlova V, McEvoy J. Cryptosporidium proliferans n. sp. (Apicomplexa: Cryptosporidiidae): Molecular and Biological Evidence of Cryptic Species within Gastric Cryptosporidium of Mammals. PLoS One. 2016 Jan 15;11(1):e0147090. doi: 10.1371/journal.pone.0147090. eCollection 2016.
- Background: PubMed 34780378Mohammad SM, Ali MS, Abdel-Rahman SA, Moustafa RA, Sarhan MH. Genotyping of Cryptosporidium species in children suffering from diarrhea in Sharkyia Governorate, Egypt. J Infect Dev Ctries. 2021 Oct 31;15(10):1539-1546. doi: 10.3855/jidc.14367.
- 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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Cryptosporidiosis, 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 6 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 17 Apr 2024. 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 Salwa GA Omran, assistant lecturer (01011154173 ext. +20, salwa.omran@med.sohag.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
estimate the prevalence and clarify the species and genotypes/subtypes of Cryptosporidium spp. in sohag. (time frame: 24 weeks). 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 NCT05208970, which also lists 4 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 17 Apr 2024.