NCT05814861

Brief Summary

  • Detection of the presence of Blastocystis hominis among outpatients presented with GIT symptoms at Assiut University Hospitals in comparison with those in control group.
  • Assessment of different culture techniques for detection, and isolation of Blastocystis hominis.
  • Molecular identification of Blastocystis hominis using polymerase chain reaction (PCR).

Trial Health

35
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
72

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Dec 2023

Status
unknown

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

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 20, 2023

Completed
29 days until next milestone

First Posted

Study publicly available on registry

April 18, 2023

Completed
8 months until next milestone

Study Start

First participant enrolled

December 1, 2023

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2024

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2024

Completed
Last Updated

April 18, 2023

Status Verified

March 1, 2023

Enrollment Period

10 months

First QC Date

March 20, 2023

Last Update Submit

April 14, 2023

Conditions

Outcome Measures

Primary Outcomes (1)

  • -Morphological identification of Blastocystis hominis in stool.

    Microscopic Detection of Blastocystis hominis among outpatients presented with GIT symptoms at Assiut University Hospitals .

    1year

Secondary Outcomes (1)

  • Molecular identification of Blastocystis hominis

    1 year

Study Arms (2)

patients presented with GIT symptoms

Fresh Stool samples will be collected in clean sterile cups from patients suffering from gastrointestinal symptoms attending Assiut University Hospitals and examined for detection of Blastocystis hominis

Diagnostic Test: culture and PCR

clinically free persons undergo routine stool analysis for any reasons other than GIT complaint

Fresh Stool samples will be collected in clean sterile cups from clinically free persons under go routine stool examination for any cause other than GIT troubles and examined for detection of Blastocystis hominis

Diagnostic Test: culture and PCR

Interventions

culture and PCRDIAGNOSTIC_TEST

Stool samples will be cultured inTwo media : A-Locke egg serum medium (LE) B- Jones' medium Then Molecular identification of Blastocystis hominis using polymerase chain reaction (PCR).

clinically free persons undergo routine stool analysis for any reasons other than GIT complaintpatients presented with GIT symptoms

Eligibility Criteria

Sexall
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

The persons selected for the study are those who are: 1. Suffering from any GIT manifestations, attending outpatient clinics of Internal Medicine and Tropical Medicine Departments at Assiut University Hospitals (case group) * GIT manifestations such as diarrhea; (frequency ≥3 loose stool /day), either acute diarrhea (duration less than 2 weeks), or chronic diarrhea (duration more than 4 weeks), or other GIT complaints as abdominal pain, flatulence, nausea, vomiting, or weight loss. 2. clinically free persons undergo routine stool analysis for any reasons other than GIT complaint.(control group)

You may qualify if:

  • The persons selected for the study are those who are:
  • Suffering from any GIT manifestations, attending outpatient clinics of Internal Medicine and Tropical Medicine Departments at Assiut University Hospitals (case group)
  • clinically free persons undergo routine stool analysis for any reasons other than GIT complaint.(control group)

You may not qualify if:

  • We will exclude any patient who received antibiotic or anti-parasitic drugs the past 4 weeks prior to sample collection.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (3)

  • A. F. Bafghi, R. Hosseini, H. R. Mollaei, and K. Barzegar, "Geno-typing and Comparison of Conventional and Molecular Diagnostic Techniques for Detection of Blastocystis on health centers in Kerman , Iran," vol. 8, no. 01, pp. 10-16, 2021..

    BACKGROUND
  • S M. Journal, "SOHAG MEDICAL JOURNAL Vol. 21 No.3," vol. 21, no. 3, 2017.

    BACKGROUND
  • M. Q. Khairuzzaman, "No Title血清及尿液特定蛋白检测在糖尿病肾病早期诊断中的意义," vol. 4, no. 1, pp. 64-75, 2016.

    BACKGROUND

MeSH Terms

Conditions

Blastocystis Infections

Condition Hierarchy (Ancestors)

Intestinal Diseases, ParasiticParasitic DiseasesInfectionsAmebiasisProtozoan InfectionsIntestinal DiseasesGastrointestinal DiseasesDigestive System Diseases

Central Study Contacts

Fatma Alzahraa montaser Ali, demonstrator

CONTACT

magda mohamed atiya Elnazer, Prof.

CONTACT

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Investigator

Study Record Dates

First Submitted

March 20, 2023

First Posted

April 18, 2023

Study Start

December 1, 2023

Primary Completion

October 1, 2024

Study Completion

December 31, 2024

Last Updated

April 18, 2023

Record last verified: 2023-03

Data Sharing

IPD Sharing
Will not share