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

NCT05213325 | Unknown

• 1 other identifier: Soh-Med-21-12-07
• Study Type: observational
• Target: 60
• Locations: 1 country
• Sites: 1

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.

Conditions

Acute Gastroenteritis; Acute Diarrhea

Outcome Measures

Primary Outcomes (2)

• Serum level of Interleukin 6

  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

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

  Within the first 3 days of acute diarrhea

Study Arms (2)

Cases

Children with acute diarrhea

Diagnostic Test: Evaluation of serum levels of IL-6 and IL-8

Control

Healthy control children

Diagnostic Test: Evaluation of serum levels of IL-6 and IL-8

Interventions

Evaluation of serum levels of IL-6 and IL-8 DIAGNOSTIC_TEST

Evaluation of serum levels of IL-6 and IL-8 by Luminex Assay (multiplexed ELISA kits)

Cases; Control

Eligibility Criteria

• Age: 6 Months - 5 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

• 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.

You may not qualify if:

• 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)
• Healthy children aged 6 months to 5 years.
• Acute diarrhea
• Malnutrition or obesity
• History of antibiotic therapy in the last 72 hours.
• Acute diarrhea in association with systemic infections
• Malignancy

Sponsors & Collaborators

• Sohag University: lead

Study Sites (1)

Sohag University Hospital

Sohag, Egypt

RECRUITING

Related Publications (3)

• Muhsen K, Kassem E, Rubenstein U, Goren S, Ephros M, Shulman LM, Cohen D. No evidence of an increase in the incidence of norovirus gastroenteritis hospitalizations in young children after the introduction of universal rotavirus immunization in Israel. Hum Vaccin Immunother. 2019;15(6):1284-1293. doi: 10.1080/21645515.2019.1599522. Epub 2019 May 3.

  PMID: 30945960 BACKGROUND

• Chen SM, Lin CP, Tsai JD, Chao YH, Sheu JN. The significance of serum and fecal levels of interleukin-6 and interleukin-8 in hospitalized children with acute rotavirus and norovirus gastroenteritis. Pediatr Neonatol. 2014 Apr;55(2):120-6. doi: 10.1016/j.pedneo.2013.05.008. Epub 2013 Jul 27.

  PMID: 23899552 BACKGROUND

• Hamiel U, Bahat H, Kozer E, Hamiel Y, Ziv-Baran T, Goldman M. Diagnostic markers of acute infections in infants aged 1 week to 3 months: a retrospective cohort study. BMJ Open. 2018 Jan 24;8(1):e018092. doi: 10.1136/bmjopen-2017-018092.

  PMID: 29371270 BACKGROUND

Central Study Contacts

John s shaker, MBBCH

CONTACT

012057258026; johnshaker@med.sohag.edu.eg

Ashraf M Radwan, MD, PhD

CONTACT

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: resident doctor at pediateric department sohag university hospital

Study Record Dates

• First Submitted: December 26, 2021
• First Posted: January 28, 2022
• Study Start: December 15, 2021
• Primary Completion: December 15, 2022
• Study Completion: December 15, 2022
• Last Updated: January 28, 2022

Record last verified: 2022-01

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)