FascioliasisNCT03869788
Parasitological Evaluation of Fascioliasis in Clinically Suspected Patients .
An observational study of Fascioliasis, run by Assiut University at 1 site in Egypt.
Trial summary
WHO considers foodborne trematodes as neglected tropical diseases. Fascioliasis is the most widely distributed trematode reported from over 81 countries around the world it imposes its highest burden in developing countries Read more about this study
- Who is it for?
- Ages 16 to 85 yearsHealthy volunteers can take part
- Conditions the study is for
- Fascioliasis
- How many people
- 50 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Sep 2019to 1 Mar 2022
- How long will I take part?
- 1 Day
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 16 to 85 years
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Study population: * Human cases complaining of previous symptoms . * Farmer . * Resident of rural area in Assiut governorate especially in Manfalout city . * Exposed to stagnant chanell water .
Who may be able to join
- vague gastrointestinal disturbances.
- intermittent eosinophilia.
- biliary obstruction.
- biliary colic pain.
- intermittent jaundice.
- right upper-quadrant abdominal tenderness.
Who cannot join
- no exclusion Criteria
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Parasitological Evaluation of Fascioliasis in Clinically Suspected Patients and the Effect of Some Plant Extract on The Adult Worm
WHO considers foodborne trematodes as neglected tropical diseases. Fascioliasis is the most widely distributed trematode reported from over 81 countries around the world it imposes its highest burden in developing countries
Read the detailed description
liver flukes are disease affecting herbivorous animals and caused by Fasciola hepatica and Fasciola gigantica In Egypt, donkeys and camels as well, are hosts for Fasciola gigantica. Fascioliasis also affects man . number of humans infected with Fasciola spp. has been estimated at 2.6 million . Globally, fascioliasis due to both fluke species is conservatively thought to cause production losses of over US$3 billion per annum .
These infection sources include foods, water and combinations of both. Ingestion of freshwater wild plants is the main source, with watercress and secondarily other vegetables involved. . Drinking of contaminated water, beverages and juices, ingestion of dishes and soups and washing of vegetables, fruits, tubercles and kitchen utensils with contaminated water are increasingly involved .
. Two clinical stages are recognized in humam fascioliasis: An acute stage coincides with the larval migration and worm maturation in the hepatic tissue, and a chronic stage coincides with the persistence of Fasciola worms in the bile ducts
- the acute phase of fascioliasis is characterized by fever, abdominal pain, hepatosplenomegaly, gastrointestinal disturbances, skin rashes, high leukocyte count, eosinophilia, anemia, and elevated erythrocyte sedimentation rate (ESR); abnormal liver function tests have also been reported .
- The latent phase is characterized by nonspecific symptoms, including vague gastrointestinal disturbances, and intermittent eosinophilia.
- The chronic phase is characterized by regular and constant biliary obstruction; symptoms include biliary colic pain, intermittent jaundice, eosinophilia, and right upper-quadrant abdominal tenderness. However, the percentage of asymptomatic infections is high .
Triclabendazole (TCBZ) is a benzimidazole derivative and is the current drug of choice for treating fascioliasis. What sets TCBZ aside from the other available fasciolicides is its ability to target flukes from as early as 3 days old right through to the fully mature stages ,. Due to the high prevalence of TCBZ resistance (TCBZ-R), effective management of drug resistance is now critical for sustainable livestock production Wich highlights the importance of plant essential oils as novel anti-parasitic agents; Some plant oils have immunomodulatory effects that could modify host- parasite immunobiology In addition, the safety and use of plant essential oils in drug resistant cases are considered the most advantages.
Allium sativum commonly called garlic belongs to the family Alliaceae. It has been used for centuries to fight infections as an antioxidant ,antibacterial, antiviral, antifungal , anti-parasitic , antihypertensive , anthelmintic, and anti- diabetic agent .
Lately, the anthelmintic effect of garlic has been a matter of interest of researchers .
It's Potentially Active Chemical Constituents are :
- Sulfur compounds: aliin, allicin, ajoene, allylpropyl disulfide, diallyl trisulfide, s- allylcysteine, vinyldithiines, S-allylmercaptocystein, and others .
- Enzymes: allinase, peroxidases, myrosinase, and others .
- Amino acids and their glycosides: arginine and others .
- Selenium, germanium, tellurium and other trace minerals . Cloves (Syzygium aromaticum) Are the dried flower buds of an aromatic tree that is used as a spice. It mainly contains volatile oil, i.e. eugenol 81.1%, caryophyllin, tannins and gum.Clove oil has been used as analgesic, antibacterial, anticonvulsant, anticoagulant, antifungal, anti-inflammatory, antioxidant, antiseptic, antitumor, antiviral, disinfectant, immune stimulant as well as insecticidal .
Nanotechnology has a wide range of action in sciences like medicine, electronics, food and agriculture. Its application has strengthen systems to control diseases in animals, water disinfection, safety in systems of food supply, energy conversion, plague localization technology, advances in fast detection of morphological changes in the physicochemical properties of food, increment in nutrient value, quality control, food security, development of novel products and packing design .
It is the current trend in research field, using small size of materials with wide range of application . In nanotechnology there is treatment of atom, molecules or compounds to produce nanoparticle with different properties .The size and structure of nanoparticle is similar to most biological molecules, therefore nano particle can be useful for in research .
There are many types of nanoparticles: organic, inorganic, nanocrystals, nanotubes, polymeric structures such as dendrimers, etc. They are used primarily in research and drug delivery systems .
In that research garlic and cloves will be used in vitro to detect their fasciolicidal effects on adult Worm obtained from locally slaughtered animals .
- Conditions
- Fascioliasis
- Medical subject headings
- Fascioliasis
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of human cases whose stool examination positive for fasciola eggs .
Stool analysis will be done to detect eggs of fasciola worm by direct smear and concentration techniques .
to patients complaining of vague gastrointestinal disturbances, and biliary colic pain, intermittent jaundice and right upper quadrant abdominal tenderness .
Measured: One year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Mar 2019
- Study start1 Sep 2019 (estimated)
- Primary completion1 Mar 2020 (estimated)
- Study completion1 Mar 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for FascioliasisStudies of the same condition, open and under way.
- More trials run by Assiut UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Cross-sectional
- Enrolment
- 50 participants (estimated)
- Target duration
- 1 Day
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Samah Mohammad Hussein, Assiut University
- Investigators
- Salma M Abdel-Rahman, prof, Study director, unaffiliation
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03869788
- Sponsor's protocol ID
- PEOFCSP
- Status last verified
- Mar 2019
- First submitted
- 6 Mar 2019
- Last updated
- 5 Jul 2019
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Nahed HA, Hoda AT, Yomna IM. Effects of garlic on albino mice experimentally infected with Schistosoma mansoni: a parasitological and ultrastructural study. Trop Biomed. 2009 Apr;26(1):40-50.
PubMed 19696726
Study at a glance
From the registry record, last updated by the sponsor on 5 Jul 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Parasitological Evaluation of Fascioliasis in Clinically Suspected Patients and the Effect of Some Plant Extract on The Adult Worm
- ClinicalTrials.gov ID
- NCT03869788
- Acronym / sponsor ID
- PEOFCSP
- Conditions
- Fascioliasis
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- 1 Sep 2019 (estimated)
- Primary completion
- 1 Mar 2020 (estimated)
- Study completion
- 1 Mar 2022 (estimated)
- First posted
- 11 Mar 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
WHO considers foodborne trematodes as neglected tropical diseases. Fascioliasis is the most widely distributed trematode reported from over 81 countries around the world it imposes its highest burden in developing countries
Detailed description
liver flukes are disease affecting herbivorous animals and caused by Fasciola hepatica and Fasciola gigantica In Egypt, donkeys and camels as well, are hosts for Fasciola gigantica. Fascioliasis also affects man . number of humans infected with Fasciola spp. has been estimated at 2.6 million . Globally, fascioliasis due to both fluke species is conservatively thought to cause production losses of over US$3 billion per annum .
These infection sources include foods, water and combinations of both. Ingestion of freshwater wild plants is the main source, with watercress and secondarily other vegetables involved. . Drinking of contaminated water, beverages and juices, ingestion of dishes and soups and washing of vegetables, fruits, tubercles and kitchen utensils with contaminated water are increasingly involved .
. Two clinical stages are recognized in humam fascioliasis: An acute stage coincides with the larval migration and worm maturation in the hepatic tissue, and a chronic stage coincides with the persistence of Fasciola worms in the bile ducts
- the acute phase of fascioliasis is characterized by fever, abdominal pain, hepatosplenomegaly, gastrointestinal disturbances, skin rashes, high leukocyte count, eosinophilia, anemia, and elevated erythrocyte sedimentation rate (ESR); abnormal liver function tests have also been reported .
- The latent phase is characterized by nonspecific symptoms, including vague gastrointestinal disturbances, and intermittent eosinophilia.
- The chronic phase is characterized by regular and constant biliary obstruction; symptoms include biliary colic pain, intermittent jaundice, eosinophilia, and right upper-quadrant abdominal tenderness. However, the percentage of asymptomatic infections is high .
Triclabendazole (TCBZ) is a benzimidazole derivative and is the current drug of choice for treating fascioliasis. What sets TCBZ aside from the other available fasciolicides is its ability to target flukes from as early as 3 days old right through to the fully mature stages ,. Due to the high prevalence of TCBZ resistance (TCBZ-R), effective management of drug resistance is now critical for sustainable livestock production Wich highlights the importance of plant essential oils as novel anti-parasitic agents; Some plant oils have immunomodulatory effects that could modify host- parasite immunobiology In addition, the safety and use of plant essential oils in drug resistant cases are considered the most advantages.
Allium sativum commonly called garlic belongs to the family Alliaceae. It has been used for centuries to fight infections as an antioxidant ,antibacterial, antiviral, antifungal , anti-parasitic , antihypertensive , anthelmintic, and anti- diabetic agent .
Lately, the anthelmintic effect of garlic has been a matter of interest of researchers .
It's Potentially Active Chemical Constituents are :
- Sulfur compounds: aliin, allicin, ajoene, allylpropyl disulfide, diallyl trisulfide, s- allylcysteine, vinyldithiines, S-allylmercaptocystein, and others .
- Enzymes: allinase, peroxidases, myrosinase, and others .
- Amino acids and their glycosides: arginine and others .
- Selenium, germanium, tellurium and other trace minerals . Cloves (Syzygium aromaticum) Are the dried flower buds of an aromatic tree that is used as a spice. It mainly contains volatile oil, i.e. eugenol 81.1%, caryophyllin, tannins and gum.Clove oil has been used as analgesic, antibacterial, anticonvulsant, anticoagulant, antifungal, anti-inflammatory, antioxidant, antiseptic, antitumor, antiviral, disinfectant, immune stimulant as well as insecticidal .
Nanotechnology has a wide range of action in sciences like medicine, electronics, food and agriculture. Its application has strengthen systems to control diseases in animals, water disinfection, safety in systems of food supply, energy conversion, plague localization technology, advances in fast detection of morphological changes in the physicochemical properties of food, increment in nutrient value, quality control, food security, development of novel products and packing design .
It is the current trend in research field, using small size of materials with wide range of application . In nanotechnology there is treatment of atom, molecules or compounds to produce nanoparticle with different properties .The size and structure of nanoparticle is similar to most biological molecules, therefore nano particle can be useful for in research .
There are many types of nanoparticles: organic, inorganic, nanocrystals, nanotubes, polymeric structures such as dendrimers, etc. They are used primarily in research and drug delivery systems .
In that research garlic and cloves will be used in vitro to detect their fasciolicidal effects on adult Worm obtained from locally slaughtered animals .
Study design
- Observational model
- Case only
- Time perspective
- Cross-sectional
- Target follow-up
- 1 Day
Who may qualify
- Ages
- 16 to 85 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- Study population
- * Human cases complaining of previous symptoms . * Farmer . * Resident of rural area in Assiut governorate especially in Manfalout city . * Exposed to stagnant chanell water .
Key inclusion criteria (6 listed)
- vague gastrointestinal disturbances.
- intermittent eosinophilia.
- biliary obstruction.
- biliary colic pain.
- intermittent jaundice.
Key exclusion criteria (1 listed)
- no exclusion Criteria
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Number of human cases whose stool examination positive for fasciola eggs .
Time frame: One year
Stool analysis will be done to detect eggs of fasciola worm by direct smear and concentration techniques . to patients complaining of vague gastrointestinal disturbances, and biliary colic pain, intermittent jaundice and right upper quadrant abdominal tenderness .
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Jul 2019.
- Background: PubMed 19696726Nahed HA, Hoda AT, Yomna IM. Effects of garlic on albino mice experimentally infected with Schistosoma mansoni: a parasitological and ultrastructural study. Trop Biomed. 2009 Apr;26(1):40-50.
- Individual participant dataSharing planned: Undecided
Related trials for Fascioliasis
Not yet recruitingPhase 2
One and Two Doses of Oxfendazole Versus a Schedule of Two Doses of Triclabendazole in Chronic Fascioliasis
Fascioliasis
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Salma M Abdel-Rahman, prof study director
unaffiliation
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Fascioliasis, run by Assiut University at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 5 Jul 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact samah M Ahmad, demonstrator (00201025180292, samahahmad0411@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of human cases whose stool examination positive for fasciola eggs . (time frame: One year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03869788, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Jul 2019.