ClinicalTrials.gg
Status unknownNCT03869788Updated Jul 5, 2019

Parasitological Evaluation of Fascioliasis in Clinically Suspected Patients .

An observational study in Fascioliasis, sponsored by Assiut University. Status unknown at 1 site in Egypt. Open to participants aged 16 Years to 85 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2019-07-05.

Sponsored by Assiut University · Observational

The sponsor has not verified this record recently (last verified Mar 2019), so the status shown — last known as Not yet recruiting — may be out of date.
Study type
Observational
Model
Case-only
Time perspective
Cross-sectional
Enrollment
50
Ages
16 Years to 85 Years
Sex
All
01

Study 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 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 .

02

Conditions studied

  • Fascioliasis
03

In context

Lead sponsor

Assiut University is the lead sponsor of 5,078 studies on the registry; 2,178 are open to participants now.

Of its 14 completed or terminated interventional studies of FDA-regulated products, 0 (0%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
16 Years to 85 Years
Sexes eligible
All
Accepts healthy volunteers
Yes
Sampling method
Probability sample

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 .

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • vague gastrointestinal disturbances.
  • intermittent eosinophilia.
  • biliary obstruction.
  • biliary colic pain.
  • intermittent jaundice.
  • right upper-quadrant abdominal tenderness.

Exclusion criteria

Exclusion Criteria:

  • no exclusion Criteria
05

Study design

Observational model
Case-only
Time perspective
Cross-sectional
Enrollment
50 participants (estimated)
Target follow-up
1 Day
Patient registry
Yes
Biospecimen retention
Samples without dna
06

What researchers measure

Primary outcomes

  1. 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 .

    Time frame: One year

07

Study locations

1 site
  • Assiut University Hospital
    Assiut, Assiut University71515, Egypt
08

References and documents

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 ↗

Individual participant data

Plan to share: Undecided

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jul 5, 2019, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT03869788
Lead sponsor
Assiut University
Responsible party
Samah Mohammad Hussein (Teaching assistant at parasitology department, Assiut University) — Principal investigator
First posted
Mar 11, 2019
Start date
Sep 1, 2019 (estimated)
Primary completion
Mar 1, 2020 (estimated)
Completion
Mar 1, 2022 (estimated)
Last update
Jul 5, 2019

Study contacts

samah M Ahmad, demonstrator
Contact
samahahmad0411@gmail.com
00201025180292
Hanaa Y Bakir, prof Dr
Contact
hanaabakeer@yahoo.com
00201022550282
Salma M Abdel-Rahman, prof
study director · unaffiliation

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Mar 2019. You cannot join it, but the record below documents what was studied.

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