NCT05208970

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.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
200

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Mar 2022

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 12, 2022

Completed
14 days until next milestone

First Posted

Study publicly available on registry

January 26, 2022

Completed
1 month until next milestone

Study Start

First participant enrolled

March 1, 2022

Completed
2.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2024

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2025

Completed
Last Updated

April 17, 2024

Status Verified

April 1, 2024

Enrollment Period

2.8 years

First QC Date

January 12, 2022

Last Update Submit

April 15, 2024

Conditions

Cryptosporidiosis

Outcome Measures

Primary Outcomes (1)

  • estimate the prevalence and clarify the species and genotypes/subtypes of Cryptosporidium spp. in sohag.

    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

    24 weeks

  • clarify the predominant clinical manifestation of each genotypes/subtypes of Cryptosporidium spp

    24 weeks

  • clarify the relationship between genotypes/subtypes of Cryptosporidium spp. and different risk factors.

    24 weeks

Eligibility Criteria

Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Outpatients at Sohag University Hospital will be sampled.

You may qualify if:

  • Age: any age
  • Sex: male -female
  • Residence: rural-urban
  • Animal contact.
  • Immune status: immunocompetent - immunocompromised
  • Clinical manifestations: diarrhea -abdominal pain- fever- vomiting.

You may not qualify if:

  • patients taking treatment for cryptosporidiosis

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Faculty of Medicine, Sohag University

Sohag, Egypt

RECRUITING

Related 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.

    PMID: 23272093BACKGROUND

  • 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.

    PMID: 27454991BACKGROUND

  • 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.

    PMID: 26771460BACKGROUND

  • 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.

    PMID: 34780378BACKGROUND

MeSH Terms

Conditions

Cryptosporidiosis

Condition Hierarchy (Ancestors)

Intestinal Diseases, ParasiticParasitic DiseasesInfectionsProtozoan Infections, AnimalParasitic Diseases, AnimalCoccidiosisProtozoan InfectionsIntestinal DiseasesGastrointestinal DiseasesDigestive System DiseasesAnimal Diseases

Central Study Contacts

Salwa GA Omran, assistant lecturer

CONTACT

01011154173salwa.omran@med.sohag.edu.eg

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
assistant lecturer of medical parasitology

Study Record Dates

First Submitted

January 12, 2022

First Posted

January 26, 2022

Study Start

March 1, 2022

Primary Completion

December 1, 2024

Study Completion

January 1, 2025

Last Updated

April 17, 2024

Record last verified: 2024-04

Locations

EG(1)