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

• Conditions: Acute Gastroenteritis; Acute Diarrhea
• Interventions: Diagnostic Test: Evaluation of serum levels of IL-6 and IL-8

• Registration Number: NCT05213325
• Lead Sponsor: Sohag University

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2021-12-15
• Study First Submitted: 2021-12-26
• Status Verified: 2022-01
• Study First Submitted QC: 2022-01-15
• Last Update Submitted: 2022-01-15
• Study First Posted: 2022-01-28
• Last Update Posted: 2022-01-28
• Primary Completion: 2022-12-15
• Study Completion: 2022-12-15

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 60

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Cases	Evaluation of serum levels of IL-6 and IL-8	Children with acute diarrhea
Control	Evaluation of serum levels of IL-6 and IL-8	Healthy control children

Primary Outcome Measures

Name	Time	Method
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
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

Trial Locations

Locations (1)

Sohag University Hospital; 🇪🇬 Sohag, Egypt