This is an experimental, multicenter, non-profit study promoted by the Department of Infectious and Tropical Diseases of the IRCCS (Istituto di Ricerca e Cura a carattere scientifico) Sacro Cuore Don Calabria of Negrar which aims to evaluate the presence of endosymbiont Wolbachia in circulating microfilariae obtained from biological samples of individuals infected with M .perstans and the presence of infection with hybrid Schistosoma species in the population of Schistosoma eggs isolated from biological samples of patients with active schistosomiasis.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
BASIC_SCIENCE
Masking
NONE
Enrollment
200
Samples of M. perstans microfilariae will be processed by PCR to investigate the presence (or absence) of Wolbachia using a set of primers targeting the genes ftsZ and 16S and optimized using reference material during the first year of the study. Samples of Schistosoma eggs from urine and feces will be processed for DNA extraction. Each sample will be genetically characterised by multi locus analysis of the mitochondrial cox1 region and the nuclear ITS and 18S rRNA regions. PCR products will be analysed by agarose gel electrophoresis and selected amplicons will be purified and Sanger sequenced. For the individuation of Schistosoma hybrids, the nuclear DNA for each sample will be confirmed by analysis of the species-specific polymorphic positions of the ITS1+2 and 18S. The mitochondrial and nuclear DNA genetic profiles for each individual sample will be recorded to determine the species involved in the infections and also any hybrid schistosomes
IRCCS Sacro Cuore Don Calabria hospital
Negrar, Verona, Italy
RECRUITINGNumber of M. perstans microfilariae
Number of samples, defined as the whole M. perstans microfilariae retrieved from one blood sample from each patient, positive for the presence of Wolbachia as assessed by PCR.
Time frame: Baseline
Percentage of M. perstans microfilariae
Percentage of samples, defined as the whole M. perstans microfilariae retrieved from one blood sample from each patient, positive for the presence of Wolbachia as assessed by PCR.
Time frame: Baseline
Number of Schistosoma eggs
Number of samples defined as the whole Schistosoma eggs retrieved from one stool or urine sample from each patient, positive for the presence Schistosoma hybrid species.
Time frame: Baseline
Percentage of Schistosoma eggs
Percentage of samples defined as the whole Schistosoma eggs retrieved from one stool or urine sample from each patient, positive for the presence Schistosoma hybrid species.
Time frame: Baseline
Number of samples positive for Wolbachia
number of samples, defined as the whole M. perstans microfilariae retrieved from one blood sample from each patient, positive for the presence of Wolbachia as assessed by PCR, by country of origin of the patient or most likely country of infection.
Time frame: Baseline
Percentage of samples positive for Wolbachia
Percentage of samples, defined as the whole M. perstans microfilariae retrieved from one blood sample from each patient, positive for the presence of Wolbachia as assessed by PCR, by country of origin of the patient or most likely country of infection.
Time frame: Baseline
Number of samples positive for Schistosoma hybrid species
number of samples defined as the whole Schistosoma eggs retrieved from one stool or urine sample from each patient, positive for the presence Schistosoma hybrid species by country of origin of the patient or most likely country of infection.
Time frame: Baseline
Percentage of samples positive for Schistosoma hybrid species
percentage of samples defined as the whole Schistosoma eggs retrieved from one stool or urine sample from each patient, positive for the presence Schistosoma hybrid species by country of origin of the patient or most likely country of infection.
Time frame: Baseline
Identification of hybrid species of Schistosoma spp.
Identification of hybrid species from each parental species of Schistosoma spp.
Time frame: Baseline
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