NCT03869788

Brief 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

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
50

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Sep 2019

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 6, 2019

Completed
5 days until next milestone

First Posted

Study publicly available on registry

March 11, 2019

Completed
6 months until next milestone

Study Start

First participant enrolled

September 1, 2019

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2020

Completed
2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2022

Completed
Last Updated

July 5, 2019

Status Verified

March 1, 2019

Enrollment Period

6 months

First QC Date

March 6, 2019

Last Update Submit

July 1, 2019

Conditions

Fascioliasis

Outcome Measures

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 .

    One year

Eligibility Criteria

Age16 Years - 85 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodProbability 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 .

You may qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Assiut University Hospital

Asyut, Assiut University71515, Egypt

Location

Related Publications (1)

  • 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.

    PMID: 19696726BACKGROUND

Biospecimen

Retention: SAMPLES WITHOUT DNA

Stool samples

MeSH Terms

Conditions

Fascioliasis

Condition Hierarchy (Ancestors)

Trematode InfectionsHelminthiasisParasitic DiseasesInfectionsLiver Diseases, ParasiticLiver DiseasesDigestive System Diseases

Study Officials

  • Salma M Abdel-Rahman, prof

    unaffiliation

    STUDY DIRECTOR

Central Study Contacts

samah M Ahmad, demonstrator

CONTACT

00201025180292samahahmad0411@gmail.com

Hanaa Y Bakir, prof Dr

CONTACT

00201022550282hanaabakeer@yahoo.com

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
CROSS SECTIONAL
Target Duration
1 Day
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Teaching assistant at parasitology department

Study Record Dates

First Submitted

March 6, 2019

First Posted

March 11, 2019

Study Start

September 1, 2019

Primary Completion

March 1, 2020

Study Completion

March 1, 2022

Last Updated

July 5, 2019

Record last verified: 2019-03

Locations

EG(1)