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

Sponsor
Sohag University (Other)
Overall Status
Recruiting
CT.gov ID
NCT05213325
Collaborator
(none)
60
1
12
5

Study Details

Study Description

Brief Summary

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.

Condition or Disease Intervention/Treatment Phase
  • Diagnostic Test: Evaluation of serum levels of IL-6 and IL-8

Study Design

Study Type:
Observational
Anticipated Enrollment :
60 participants
Observational Model:
Case-Control
Time Perspective:
Cross-Sectional
Official Title:
Evaluation of Serum Interleukin 6 and 8 in Children With Acute Gastroentritis
Actual Study Start Date :
Dec 15, 2021
Anticipated Primary Completion Date :
Dec 15, 2022
Anticipated Study Completion Date :
Dec 15, 2022

Arms and Interventions

Arm 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)

Outcome Measures

Primary Outcome Measures

  1. Serum level of Interleukin 6 [Within the first 3 days of acute diarrhea]

    Difference in serum level of interleukin 6 between cases and control groups

  2. Serum level of Interleukin 8 [Within the first 3 days of acute diarrhea]

    Difference in serum level of interleukin 8 between cases and control groups

Eligibility Criteria

Criteria

Ages Eligible for Study:
6 Months to 5 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No

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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Sohag University Hospital Sohag Egypt

Sponsors and Collaborators

  • Sohag University

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

Responsible Party:
John Samuel Shaker, resident doctor at pediateric department sohag university hospital, Sohag University
ClinicalTrials.gov Identifier:
NCT05213325
Other Study ID Numbers:
  • Soh-Med-21-12-07
First Posted:
Jan 28, 2022
Last Update Posted:
Jan 28, 2022
Last Verified:
Jan 1, 2022
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of Jan 28, 2022