Clinical trial NCT05213325: Evaluation of Serum Interleukin 6 and 8 in Children With Acute Gastroenteritis
Official title: Evaluation of Serum Interleukin 6 and 8 in Children With Acute Gastroentritis
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Acute Gastroenteritis
Acute Diarrhea
Lead sponsor: Sohag University
Sponsor class: OTHER
First posted: 2022-01-28
Enrollment: 60
Sex: ALL
Minimum age (years): 6
Maximum age (years): 5
Standard ages: CHILD
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Children presented to the Pediatric Department and Outpatient Clinic at Sohag University Hospital

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.


Eligibility criteria: 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

Primary outcomes:
measure: Serum level of Interleukin 6
timeFrame: Within the first 3 days of acute diarrhea
measure: Serum level of Interleukin 8
timeFrame: Within the first 3 days of acute diarrhea
Secondary outcomes:
Other outcomes:
Locations:
city: Sohag
country: Egypt
facility: Sohag University Hospital
Study officials:
References:
citation: 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.
citation: 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.
citation: 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.