Clinical Trial Details
— Status: Not yet recruiting
Administrative data
| NCT number |
NCT03614286 |
| Other study ID # |
T V Genotyping |
| Secondary ID |
|
| Status |
Not yet recruiting |
| Phase |
|
| First received |
|
| Last updated |
|
| Start date |
October 2018 |
| Est. completion date |
March 2020 |
Study information
| Verified date |
August 2018 |
| Source |
Assiut University |
| Contact |
Ahmed Kamal Dyab, Professor |
| Phone |
+201018614645 |
| Email |
ahmedsaf2001[@]yahoo.com |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Observational
|
Clinical Trial Summary
The worldwide incidence of trichomoniasis was estimated to be 276.4 million new cases per
year in 2008 .In Egypt, the reported prevalence rate ranges from 5% to 79.16% we aim to study
genetic variability of Trichomonas vaginalis using PCR
Description:
In women, trichomoniasis has a wide range of presentations, from asymptomatic to acute or
chronic inflammatory disease they include urethral discharge and dysuria. Among women, common
sites of infection include the vagina, urethra and endocervix. Symptoms include vaginal
discharge (which is often diffuse, malodorous, yellow-green), dysuria, itching, vulvar
irritation and abdominal pain. The normal vaginal pH is 4.5, but with TV infection this
increases markedly, often to >5 Colpitis macularis or strawberry cervix is seen in about 5 %
of women, though with colposcopy this rises to nearly 50 % .Other complications include
infection of the adnexa, endometrium, and Skene and Bartholin glands. In men, it can cause
epididymitis, prostatitis, and decreased sperm cell motility .
A lot of risk factors of infection are related to age, educational level, residence,
race/ethnicity, marital status, number of sex partners, use of condom/IUD, history of
sexually transmitted diseases and presence of vaginal discharge .
Traditionally physicians make the diagnosis based on clinical grounds, but in women, the
characteristics of the vaginal discharge, including color and odor, are poor predictors of T.
vaginalis. Since no symptom alone or in combination is sufficient to diagnose T. vaginalis
infection reliably, laboratory diagnosis is necessary ,Diagnosis of T. vaginalis infection is
established by the traditional method wet mount test, in which "corkscrew" motility observed
. Anyhow, culture has long been the gold standard for diagnosing T. vaginalis infection ,
with a sensitivity range from 85-95 % . Other used methods for diagnosis include
enzyme-linked immunosorbent assay , staining methods latex agglutination ,
immunochromatography and nucleic acid amplification tests .In order to develop protocol for
the diagnosis of trichomoniasis, ideal test should have high sensitivity and specificity and
be easily available, simple to perform, and inexpensive Knowledge of the genetic
characteristics of T. vaginalis populations is valuable for the prevention and control of
trichomoniasis in humans .
The lengths of specific regions in the small subunit of nuclear ribosomal RNA (SSU nrRNA,
also known as 18S rRNA) are not conserved among different groups, and these differences can
be significant. Thus, 18S rRNA is suitable to study genetic variations and genotypes of
organisms.
The use of reliable classification and genetic characterization methods can help to clarify
the ambiguities in this field.
Multiple approaches to typing Trichomonas isolates have been described; antigenic
characterization, ribosomal gene and intergenic region sequence polymorphisms, random
amplified polymorphic DNA analysis, and restriction fragment length polymorphism .These
studies produced differing results, even when using similar techniques, in attempting to
demonstrate concordance between parasite genotypes and phenotypic expressions during
infection, such as virulence and metronidazole resistance. The T. vaginalis genome
composition provides a potential explanation for this difficulty in correlating genotype with
phenotype.
