Evaluation of Serum Interleukin 6 and 8 in Children With Acute Gastroenteritis

January 15, 2022 updated by: John Samuel Shaker, Sohag University

Evaluation of Serum Interleukin 6 and 8 in Children With Acute Gastroentritis

Cytokines, such as IL-6 and IL-8 can be used as markers of acute infections, including acute gastroenteritis. This study aims to evaluate serum levels of interleukins 6 and 8 in children with acute gastroenteritis.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Anticipated)

60

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 Contact Backup

  • Name: Ashraf M Radwan, MD, PhD

Study Locations

  • Egypt
      • Sohag, Egypt
        • Recruiting
        • Sohag University Hospital

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

6 months to 5 years (CHILD)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Children presented to the Pediatric Department and Outpatient Clinic at Sohag University Hospital

Description

Group 1: Cases (Children with acute diarrhea)

Inclusion Criteria:

  • Children aged 6 months to 5 years.
  • Acute diarrhea: defined according to WHO criteria as the "passage of loose or watery stools at least three times in a 24 h period", lasts less than 14 days, with or without fever or vomiting, but considering the importance of change in stool consistency rather than frequency, and the usefulness of parental insight in deciding whether children have diarrhea or not.

Exclusion Criteria:

  • Malnutrition or obesity
  • History of antibiotic therapy in the last 72 hours.
  • Acute diarrhea in association with systemic infections
  • Malignancy
  • Chronic diarrhea
  • Autoimmune and autoinflammatory diseases.
  • Chronic renal/liver failure
  • Diabetes mellitus

Group 2: Controls (Healthy control children)

Inclusion Criteria:

• Healthy children aged 6 months to 5 years.

Exclusion Criteria:

  • Acute diarrhea
  • Malnutrition or obesity
  • History of antibiotic therapy in the last 72 hours.
  • Acute diarrhea in association with systemic infections
  • Malignancy
  • Chronic diarrhea
  • Autoimmune and autoinflammatory diseases.
  • Chronic renal/liver failure
  • Diabetes mellitus

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
Intervention / Treatment
Cases
Children with acute diarrhea
Diagnostic test: Evaluation of serum levels of IL-6 and IL-8
Evaluation of serum levels of IL-6 and IL-8 by Luminex Assay (multiplexed ELISA kits)
Control
Healthy control children
Diagnostic test: Evaluation of serum levels of IL-6 and IL-8
Evaluation of serum levels of IL-6 and IL-8 by Luminex Assay (multiplexed ELISA kits)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Serum level of Interleukin 6
Time Frame: Within the first 3 days of acute diarrhea
Difference in serum level of interleukin 6 between cases and control groups
Within the first 3 days of acute diarrhea
Serum level of Interleukin 8
Time Frame: Within the first 3 days of acute diarrhea
Difference in serum level of interleukin 8 between cases and control groups
Within the first 3 days of acute diarrhea

Collaborators and Investigators

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

Sponsor

Sohag University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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 (ACTUAL)

December 15, 2021

Primary Completion (ANTICIPATED)

December 15, 2022

Study Completion (ANTICIPATED)

December 15, 2022

Study Registration Dates

First Submitted

December 26, 2021

First Submitted That Met QC Criteria

January 15, 2022

First Posted (ACTUAL)

January 28, 2022

Study Record Updates

Last Update Posted (ACTUAL)

January 28, 2022

Last Update Submitted That Met QC Criteria

January 15, 2022

Last Verified

January 1, 2022

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Soh-Med-21-12-07

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

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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