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

Acute Gastroenteritis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05213325
• Other study ID #: Soh-Med-21-12-07
• Status: Recruiting
• Start date: December 15, 2021
• Est. completion date: December 15, 2022

Study information

• Verified date: January 2022
• Source: Sohag University
• Contact: John s shaker, MBBCH
• Phone: 012057258026
• Email: johnshaker[@]med.sohag.edu.eg
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 60
• Est. completion date: December 15, 2022
• Est. primary completion date: December 15, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 6 Months to 5 Years

Eligibility

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

Related Conditions & MeSH terms

• Acute Diarrhea
• Acute Gastroenteritis
• Diarrhea
• Gastroenteritis

Intervention

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)

Locations

Country	Name	City	State
Egypt	Sohag University Hospital	Sohag

Sponsors (1)

Lead Sponsor	Collaborator
Sohag University

Country where clinical trial is conducted

Egypt, 

References & Publications (3)

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. — View 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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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