Fecal Calprotectin in Patients Infected with Intestinal P... | NCT06890455

Studies
Fecal Calprotectin in Patients Infected with Intestinal Protozoan Infections

NCT06890455

Sponsor

Sohag University

Status

Not yet recruiting

Last Update Posted

Mar 24, 2025Actual

Enrollment

120Estimated

Phase

Not provided

Conditions

Fecal Calprotectin in Intestinal Protozoa

Interventions

Not provided

Countries

Egypt

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Mar 2025

Overall Recruitment Status or Expanded Access Status

Not yet recruiting

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Mar 2025Estimated

Primary Completion Date

Oct 2025Estimated

Completion Date

Feb 2026Estimated

First Submitted Date

Mar 17, 2025

First Submission Date that Met QC Criteria

Mar 17, 2025

First Posted Date

Mar 24, 2025Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Mar 17, 2025

Last Update Posted Date

Mar 24, 2025Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

FDAAA801 Violation

Not provided

Description Module

Brief Summary

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.

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Yes

Target Follow-Up Duration

1 Day

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

120Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
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).

Interventions

Not provided

Measure	Description	Time Frame
Prevalence of Blastocystis and Entamoeba		2 months

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

Eligibility Module

Eligibility Criteria

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

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

Not provided

Maximum Age

Not provided

Standard Ages

ChildAdultOlder Adult

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).

Sampling Method

Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Youstina Kamel Boles, Demonstrator	Contact	+20 12 73435308		youstena.kamel@med.sohag.edu.eg

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Sohag University		Sohag			Egypt	Youstina Kamel Boles, Demonstrator

IPD Sharing Statement Module

Plan to Share IPD

Undecided

Description

Not decided yet

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided