Fecal Calprotectin in Patients Infected with Intestinal Protozoan Infections

March 17, 2025 updated by: Youstina Kamel Boles, Sohag University
Calprotectin extracted from stool can be detected easily using ELISA. Numerous studies have shown that fecal calprotectin concentrations demonstrate a good correlation with intestinal inflammation This study aims to detect the relationship between fecal calprotectin and Blastocystis hominis and Entamoeba histolytica infections.

Study Overview

Status

Not yet recruiting

Conditions

Study Type

Observational

Enrollment (Estimated)

120

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Sampling Method

Probability Sample

Study Population

120 fecal samples will be collected as the following:

  • 40 samples from patients complaining of gastrointestinal manifestations and only infected with B.hominis and E.histolytica.
  • 40 samples from patients complaining of gastrointestinal manifestations without any protozoal infection.
  • 40 healthy control cross-matched volunteers (without gastrointestinal manifestations, or intestinal parasites).

Description

Inclusion Criteria:

120 fecal samples will be collected as the following:

  • 40 samples from patients complaining of gastrointestinal manifestations and only infected with B.hominis and E.histolytica.
  • 40 samples from patients complaining of gastrointestinal manifestations without any protozoal infection.
  • 40 healthy control cross-matched volunteers (without gastrointestinal manifestations, or intestinal parasites).

Exclusion Criteria:

  • persons received antiparasitic drugs or antibiotic 2 weeks before sample collection Patients with mixed intestinal protozoa Patients with intestinal protozoa rather than Entamoeba histolytica and Blastocystis

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Case group
40 patients complaining of gastrointestinal manifestations and infected with Blastocystis or Entamoeba histolytica
Control group 1
40 persons complaining of gastrointestinal manifestations without any protozoal infections
Control group 2
- 40 healthy control cross-matched volunteers (without gastrointestinal manifestations, or intestinal parasites).

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Prevalence of Blastocystis and Entamoeba
Time Frame: 2 months
2 months

Secondary Outcome Measures

Outcome Measure
Time Frame
Number of persons have high fecal calprotectin
Time Frame: 6 months
6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sohag University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

March 1, 2025

Primary Completion (Estimated)

October 1, 2025

Study Completion (Estimated)

February 1, 2026

Study Registration Dates

First Submitted

March 17, 2025

First Submitted That Met QC Criteria

March 17, 2025

First Posted (Actual)

March 25, 2025

Study Record Updates

Last Update Posted (Actual)

March 25, 2025

Last Update Submitted That Met QC Criteria

March 17, 2025

Last Verified

March 1, 2025

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Soh-Med--25-3-07MS

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

IPD Plan Description

Not decided yet

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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