Schistosoma Mansoni
Conditions
Brief summary
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.
Interventions
DIAGNOSTIC_TESTMolecular biology analyses
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
Sponsors
IRCCS Sacro Cuore Don Calabria di Negrar
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
BASIC_SCIENCE
Masking
NONE
Eligibility
Sex/Gender
ALL
Healthy volunteers
No
Inclusion criteria
* samples from patients who gave consent to the storage and use for research purposes of their samples. In the case a network centre necessitates a template for the storage and use for research purposes of their samples; * samples collected before any treatment with praziquantel and/or benzimidazole and/or avermectin and/or diethylcarbamazine and/or doxycycline drug; * samples collected and stored in conditions suitable for this study (Annex 2); * known country of birth of the patient or of most likely infection (if different from the country of birth)
Exclusion criteria
\- no compliance with at least one of the above-mentioned inclusion criteria.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of M. perstans microfilariae | Baseline | 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. |
| Percentage of M. perstans microfilariae | Baseline | 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. |
| Number of Schistosoma eggs | Baseline | 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. |
| Percentage of Schistosoma eggs | Baseline | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of samples positive for Wolbachia | Baseline | 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. |
| Identification of hybrid species of Schistosoma spp. | Baseline | Identification of hybrid species from each parental species of Schistosoma spp. |
| Percentage of samples positive for Wolbachia | Baseline | 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. |
| Number of samples positive for Schistosoma hybrid species | Baseline | 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. |
| Percentage of samples positive for Schistosoma hybrid species | Baseline | 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. |
Countries
Italy
Outcome results
None listed