Cryptosporidium Species in Sohag Governorate

Cryptosporidiosis Clinical Trial

Official title:

Genetic Diversity of Cryptosporidium Species Infecting Human in Sohag Governorate

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05208970
• Other study ID #: Soh-Med-22-01-12
• Status: Recruiting
• Start date: March 1, 2022
• Est. completion date: January 2025

Study information

• Verified date: April 2024
• Source: Sohag University
• Contact: Salwa GA Omran, assistant lecturer
• Phone: 01011154173
• Email: salwa.omran[@]med.sohag.edu.eg
• Is FDA regulated: No
• Study type: Observational

Clinical 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 200
• Est. completion date: January 2025
• Est. primary completion date: December 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: N/A and older

Eligibility

Inclusion Criteria:

1. Age: any age

2. Sex: male -female

3. Residence: rural-urban

4. Animal contact.

5. Immune status: immunocompetent - immunocompromised

6. Clinical manifestations: diarrhea -abdominal pain- fever- vomiting.

Exclusion Criteria:

• patients taking treatment for cryptosporidiosis

Related Conditions & MeSH terms

• Cryptosporidiosis

Locations

Country	Name	City	State
Egypt	Faculty of Medicine, Sohag University	Sohag

Sponsors (1)

Lead Sponsor	Collaborator
Sohag University

Country where clinical trial is conducted

Egypt, 

References & Publications (4)

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. — View Citation

Kvac 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. — View Citation

Mohammad 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. — View Citation

Ryan 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	estimate the prevalence and clarify the species and genotypes/subtypes of Cryptosporidium spp. in sohag.		24 weeks
Secondary	clarify the relationship of them in a phylogenetic context and to provide additional information on the molecular epidemiology of this parasite in our locality		24 weeks
Secondary	clarify the predominant clinical manifestation of each genotypes/subtypes of Cryptosporidium spp		24 weeks
Secondary	clarify the relationship between genotypes/subtypes of Cryptosporidium spp. and different risk factors.		24 weeks