Clinical trial NCT05208970: Cryptosporidium Species in Sohag Governorate
Official title: Genetic Diversity of Cryptosporidium Species Infecting Human in Sohag Governorate
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Cryptosporidiosis
Lead sponsor: Sohag University
Sponsor class: OTHER
First posted: 2022-01-26
Enrollment: 200
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_ONLY
Time perspective: CROSS_SECTIONAL
Sampling method: PROBABILITY_SAMPLE
Study population: Outpatients at Sohag University Hospital will be sampled.

Brief 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.


Eligibility criteria: 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

Primary outcomes:
measure: estimate the prevalence and clarify the species and genotypes/subtypes of Cryptosporidium spp. in sohag.
timeFrame: 24 weeks
Secondary outcomes:
measure: clarify the relationship of them in a phylogenetic context and to provide additional information on the molecular epidemiology of this parasite in our locality
timeFrame: 24 weeks
measure: clarify the predominant clinical manifestation of each genotypes/subtypes of Cryptosporidium spp
timeFrame: 24 weeks
measure: clarify the relationship between genotypes/subtypes of Cryptosporidium spp. and different risk factors.
timeFrame: 24 weeks
Other outcomes:
Locations:
city: Sohag
country: Egypt
facility: Faculty of Medicine, Sohag University
Study officials:
References:
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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.
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.
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.